Telisotuzumab Adizutecan (Temab-A, ABBV-400) Clinical Trials (October 2026): 12 Recruiting Interventional Studies in Refractory Colorectal Cancer, EGFR Wild-Type and EGFR-Mutant NSCLC, Pancreatic Cancer, Head and Neck Cancer, and MET-Amplified Solid Tumors

Last updated: October 21, 2026

Drug profile:

Telisotuzumab adizutecan (Temab-A, ABBV-400) is AbbVie's next-generation c-Met-directed antibody-drug conjugate (ADC). It reuses telisotuzumab — the humanized bivalent IgG1 anti-c-Met antibody of the FDA-approved Emrelis (telisotuzumab vedotin) — but swaps Emrelis's microtubule-inhibitor MMAE payload for a topoisomerase 1 inhibitor (Top1i) on AbbVie's adizutecan linker-payload platform. It is being developed across solid tumors in the AndroMETa program: colorectal, non-small cell lung, pancreatic and pancreatobiliary, head and neck, gastroesophageal, hepatocellular, and MET-amplified tumors.

Mechanism of action:

The antibody binds c-Met (the MET receptor tyrosine kinase, the receptor for hepatocyte growth factor), a protein overexpressed in many carcinomas and linked to progression and treatment resistance. After binding, the ADC is internalized, the cleavable valine-alanine linker is cut by lysosomal proteases, and the released Top1i payload traps topoisomerase 1 on DNA, causing double-strand breaks during replication and apoptosis. Like other Top1i payloads (deruxtecan in Enhertu and Datroway, SN-38 in Trodelvy), the payload is membrane-permeable and exerts a bystander effect on neighboring tumor cells, so activity does not require every cell to express c-Met.

Regulatory status:

Not FDA-approved. On October 7, 2026 the FDA granted telisotuzumab adizutecan its first two Breakthrough Therapy Designations: (1) in combination with bevacizumab for refractory metastatic colorectal cancer after fluoropyrimidine, irinotecan, oxaliplatin, anti-VEGF and (if indicated) anti-EGFR therapy; and (2) as monotherapy for previously treated, EGFR wild-type, c-Met protein-expressing non-squamous NSCLC after platinum chemotherapy and an anti-PD-(L)1 antibody. A Breakthrough Therapy Designation expedites FDA interaction and review on the basis of preliminary clinical evidence — it is not an approval, and the confirmatory Phase 3 trials have not read out. Access today is through clinical trials only.

Why Telisotuzumab Adizutecan Matters — In Plain Language

c-Met has been a frustrating target for a long time. The MET pathway is switched on in a large share of colorectal, lung, gastric, pancreatic and head and neck cancers, but a decade of MET-blocking antibodies and kinase inhibitors in unselected patients mostly failed, and the one group that clearly benefits from MET kinase inhibitors is the small population whose tumors carry MET exon 14 skipping mutations (capmatinib, tepotinib). An ADC changes the logic: it does not need to shut down MET signaling — it only needs c-Met to be present on the cell surface as an address for delivering chemotherapy. That is why the first c-Met ADC, Emrelis, could win FDA accelerated approval (May 2025) in c-Met-overexpressing NSCLC where MET inhibitors never did.

Telisotuzumab adizutecan is the second-generation version of that idea. Replacing Emrelis's MMAE payload with a topoisomerase 1 inhibitor matters for two reasons. First, Top1i payloads are the chemistry behind the most successful ADCs of the past five years (Enhertu, Datroway, Trodelvy) and have a bystander effect that MMAE largely lacks, which may let the drug work in tumors with patchy or moderate c-Met expression. Second, the payload class changes the side-effect profile: away from the peripheral neuropathy and eye toxicity of MMAE and toward the nausea, fatigue and low blood counts — plus a monitored interstitial lung disease risk — of Top1i ADCs.

The two Breakthrough Therapy Designations point to where the drug may land first. The colorectal designation targets patients whose cancer has already progressed through every standard chemotherapy and antibody — a setting where the current options (LONSURF plus bevacizumab, regorafenib) add months, not years. The NSCLC designation targets patients without an EGFR mutation whose cancer has progressed after platinum chemotherapy and immunotherapy, where docetaxel has been the default for twenty years. Honest framing: the designations rest on early-phase data, principally the first-in-human study (NCT05029882) and the AndroMETa Phase 2 dose-optimization trials, which have not been peer-reviewed in full; the randomized Phase 3 trials that will decide whether telisotuzumab adizutecan actually extends survival are either recruiting now (colorectal) or about to open (NSCLC). This page does not quote response rates from those early studies because they are interim and dose-dependent.

Regulatory Milestones

Telisotuzumab adizutecan has 0 FDA approvals and 2 Breakthrough Therapy Designations (both granted October 7, 2026). For comparison, its MMAE-payload sibling Emrelis (telisotuzumab vedotin) has 1 accelerated approval (May 14, 2025, c-Met-overexpressing NSCLC).

1. Breakthrough Therapy Designation — Refractory Metastatic Colorectal Cancer, with Bevacizumab (October 7, 2026)

Population: adults with refractory metastatic colorectal cancer previously treated with fluoropyrimidine, irinotecan, oxaliplatin, an anti-VEGF monoclonal antibody and, if indicated, an anti-EGFR monoclonal antibody · Regimen: telisotuzumab adizutecan + bevacizumab · Confirmatory trial: global Phase 3 (NCT07525206, n≈990) vs LONSURF (trifluridine/tipiracil) + bevacizumab, the current standard in this line · Supporting Phase 2: AndroMETa-CRC-064 dose optimization (NCT06614192, active, not recruiting) and the Phase 2 bevacizumab / FOLFIRI combination study (NCT06107413, active, not recruiting) · What it means: the FDA sees preliminary evidence of substantial improvement over available therapy in a line where options are limited — not an approval.

2. Breakthrough Therapy Designation — Previously Treated EGFR Wild-Type, c-Met-Expressing Non-Squamous NSCLC, Monotherapy (October 7, 2026)

Population: adults with locally advanced or metastatic, EGFR wild-type, c-Met protein-expressing, non-squamous NSCLC previously treated with platinum-based chemotherapy and an anti-PD-(L)1 antibody · Regimen: telisotuzumab adizutecan monotherapy · Confirmatory trial: Phase 3 (NCT07821684, n≈660) vs docetaxel or ramucirumab, registered and not yet recruiting as of October 2026 (planned start January 2027) · Biomarker: c-Met protein expression above a defined cutoff by immunohistochemistry — the same testing concept as Emrelis, with the trial-specific threshold set in the protocol · Note the EGFR wild-type restriction: EGFR-mutant patients are studied separately (see the osimertinib combination trials below).

★ Breakthrough Therapy Designation Is Not Approval — What Changes and What Does Not

A Breakthrough Therapy Designation (BTD) is an FDA process status. It is granted when preliminary clinical evidence indicates a drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint. The sponsor receives intensive FDA guidance on trial design, organizational commitment from senior reviewers, rolling review, and eligibility for priority review. It frequently precedes an accelerated approval based on response rate, with full approval contingent on a confirmatory Phase 3.

What does not change: the drug is not available by prescription, insurers do not cover it, and no survival benefit has been demonstrated. Patients and families reading "FDA Breakthrough" headlines should understand that the practical route to telisotuzumab adizutecan in late 2026 is enrollment in one of the AndroMETa trials listed below, or, where offered, an expanded-access program through the sponsor and treating oncologist.

What the two designations do tell you is where AbbVie and the FDA believe the signal is strongest: refractory colorectal cancer in combination with bevacizumab, and EGFR wild-type c-Met-expressing NSCLC after chemotherapy and immunotherapy. If you are in either of those situations, the Phase 3 trials for those populations are the most directly relevant studies on this page.

Recruiting Telisotuzumab Adizutecan Trials

All 12 recruiting interventional telisotuzumab adizutecan / ABBV-400 trials on ClinicalTrials.gov as of October 21, 2026, each verified in the ClinTrialFinder corpus. Grouped by clinical setting and ordered by phase. All are sponsored by AbbVie unless noted.

Phase 3 — Refractory Metastatic Colorectal Cancer (BTD Confirmatory)

NCT07525206 — Phase 3 (Global, Open-Label, Randomized; n≈990): Telisotuzumab adizutecan + bevacizumab vs LONSURF (trifluridine/tipiracil) + bevacizumab in refractory metastatic colorectal cancer. The confirmatory trial behind the colorectal Breakthrough Therapy Designation — LONSURF + bevacizumab (SUNLIGHT regimen) is the current third-line standard, so a win here would establish a new standard of care rather than an add-on. Started May 2026. Status: Recruiting.

Phase 2 — Colorectal Cancer (ctDNA-Positive Adjuvant, Combination Master Protocol)

NCT07023289 — Phase 2 (Randomized; n≈140): Telisotuzumab adizutecan monotherapy vs standard of care in post-adjuvant, ctDNA-positive colorectal cancer with no radiographic evidence of disease. A molecular-residual-disease trial — patients who have finished surgery and adjuvant chemotherapy but whose blood test still detects tumor DNA, a group at very high relapse risk with no established intervention. One of the first ADC trials in the ctDNA-positive NED setting. Status: Recruiting.
NCT06820463 — Phase 2 (Open-Label, Randomized Master Protocol; n≈390): Telisotuzumab adizutecan in multiple combinations — with FOLFOX (oxaliplatin, fluorouracil, folinic acid), bevacizumab, and panitumumab — in metastatic colorectal cancer. Tests the drug in earlier lines alongside the standard chemotherapy and antibody backbones, exploring whether a c-Met ADC can move up from the refractory setting. Status: Recruiting.

Phase 2/3 — EGFR-Mutant Non-Squamous NSCLC (with Osimertinib)

NCT07005102 — Phase 2/3 (Randomized; n≈854): Telisotuzumab adizutecan + osimertinib as first-line treatment vs standard of care (osimertinib-based, with platinum/pemetrexed chemotherapy arms) in locally advanced unresectable or metastatic EGFR-mutated non-squamous NSCLC. Tests whether adding a c-Met ADC to first-line osimertinib delays resistance — MET amplification is one of the most common ways EGFR-mutant tumors escape osimertinib, so pairing the two from the start is mechanistically rational. Status: Recruiting.
NCT07155187 — Phase 2/3 (AndroMETa-Lung-713, Randomized; n≈490): Telisotuzumab adizutecan monotherapy or + osimertinib vs standard of care in EGFR-mutated non-squamous NSCLC after progression on a third-generation EGFR TKI. The post-osimertinib setting, where platinum chemotherapy (with or without amivantamab) is the current standard and several ADCs (Datroway, patritumab deruxtecan) are competing. Status: Recruiting.

Phase 1b/2 — First-Line Non-Squamous NSCLC Without Actionable Mutations (with PD-1 Inhibitor)

NCT06772623 — Phase 1b/2 (Multi-Cohort; n≈252): Telisotuzumab adizutecan + a PD-1 inhibitor (budigalimab or pembrolizumab), with or without platinum/pemetrexed, as first-line treatment for advanced non-squamous NSCLC with no actionable genomic alterations. The ADC + immunotherapy first-line question — tests whether a c-Met ADC can replace or augment chemotherapy in the KEYNOTE-189-type population. Status: Recruiting.

Phase 2/3 and Phase 2 — Pancreatic and Pancreatobiliary Cancers

NCT07490301 — Phase 2/3 (AndroMETa-PDAC-288, Open-Label, Randomized; n≈900): Telisotuzumab adizutecan + FOLFOX vs standard of care (FOLFIRINOX-type or gemcitabine-based) as first-line treatment for metastatic pancreatic ductal adenocarcinoma. One of the largest first-line pancreatic cancer trials of any ADC — c-Met is broadly overexpressed in PDAC, and the FOLFOX backbone lets the Top1i payload stand in for the irinotecan component of FOLFIRINOX. Started April 2026. Status: Recruiting.
NCT07769502 — Phase 2 (AndroMETa-118, Open-Label Master Protocol; n≈168): Telisotuzumab adizutecan combinations with gemcitabine and nab-paclitaxel in pancreatobiliary cancers (pancreatic ductal adenocarcinoma and biliary tract cancers). Companion to AndroMETa-PDAC-288 testing the other first-line chemotherapy backbone. Status: Recruiting.

Phase 2 — First-Line Recurrent / Metastatic Head and Neck Squamous Cell Carcinoma (with Pembrolizumab)

NCT07744126 — Phase 2 (Open-Label, Randomized, Dose-Optimization; n≈150): Telisotuzumab adizutecan + pembrolizumab vs pembrolizumab + platinum/fluorouracil as first-line treatment for recurrent or metastatic HNSCC. Tests a chemotherapy-sparing first-line regimen in a disease where c-Met overexpression is common and the KEYNOTE-048 pembrolizumab-based standards leave most patients progressing within a year. Status: Recruiting.

Phase 2 — Tumor-Agnostic MET-Amplified Solid Tumors (Age 12+)

NCT07196644 — Phase 2 (Single-Arm; n≈100): Telisotuzumab adizutecan monotherapy in participants 12 years and older with locally advanced or metastatic solid tumors harboring MET amplification. A tissue-agnostic biomarker trial — MET amplification (extra gene copies, detected by NGS or FISH) drives very high c-Met surface expression, making these tumors a natural fit for a c-Met ADC regardless of organ of origin. Also notable for including adolescents. Status: Recruiting.

Phase 1 — Expansion in Selected Solid Tumors and Combination Platforms

NCT06084481 — Phase 1 (Open-Label Expansion; n≈325): ABBV-400 monotherapy and with bevacizumab in selected advanced solid tumors — hepatocellular carcinoma, pancreatic ductal adenocarcinoma, biliary tract cancers, esophageal squamous cell carcinoma, and others. The signal-finding study that identifies which additional tumor types justify their own Phase 2/3 program. Includes a drug-interaction sub-study with itraconazole. Status: Recruiting.
NCT05005403 — Phase 1 (First-in-Human Combination Platform; n≈694): Azirkitug (an AbbVie investigational immunotherapy) alone and in combination with budigalimab, bevacizumab, or telisotuzumab adizutecan in NSCLC, HNSCC and other solid tumors. Telisotuzumab adizutecan is one of several combination partners here rather than the lead agent. Status: Recruiting.

Registered, Not Yet Recruiting — and Closed-to-Enrollment Trials Worth Knowing

NCT07821684 — Phase 3 (Open-Label, Randomized; n≈660): Telisotuzumab adizutecan vs standard of care (docetaxel or ramucirumab) in previously treated, EGFR wild-type, c-Met-expressing non-squamous NSCLC. The confirmatory trial for the NSCLC Breakthrough Therapy Designation. Planned start January 2027. Status: Not yet recruiting.
NCT07874282 — Phase 2 (RemeGen; n≈200): Telisotuzumab adizutecan + RC148 (a RemeGen bispecific) as first-line therapy for non-squamous NSCLC, in China. Status: Not yet recruiting.
Closed to enrollment (active, not recruiting): the first-in-human Phase 1 NCT05029882 (ABBV-400 monotherapy and + bevacizumab, advanced solid tumors, n≈520 — the principal source of the early colorectal and NSCLC data), AndroMETa-CRC-064 dose optimization NCT06614192, the Phase 2 colorectal bevacizumab / FOLFIRI combination study NCT06107413, and AndroMETa-GEA-977 NCT06628310 (first-line gastric / GEJ / esophageal adenocarcinoma with fluorouracil, leucovorin and budigalimab). Their readouts will shape the next wave of trials.

Showing all 12 recruiting interventional telisotuzumab adizutecan / ABBV-400 trials as of October 21, 2026 (ClinicalTrials.gov term search "telisotuzumab adizutecan OR ABBV-400", recruiting + interventional = 12). For the latest list: view all recruiting telisotuzumab adizutecan trials on ClinicalTrials.gov.

Mechanism: Anti-c-Met IgG1 × Topoisomerase 1 Inhibitor (Adizutecan Platform)

Target: c-Met (MET receptor tyrosine kinase; hepatocyte growth factor receptor) — a transmembrane receptor expressed at low levels on normal epithelium and overexpressed in a large fraction of colorectal, non-small cell lung, gastric / gastroesophageal, pancreatic, hepatocellular, and head and neck cancers. Binding of its ligand HGF drives proliferation, invasion and survival signaling, and MET activation is a well-documented resistance mechanism to EGFR inhibitors in lung and colorectal cancer. For an ADC, what matters is not MET signaling but surface protein density: more c-Met per cell means more ADC internalized and more payload delivered. c-Met protein is measured by immunohistochemistry (IHC) on tumor tissue; AbbVie's trials define expression cutoffs in each protocol.

Antibody: telisotuzumab, a humanized bivalent IgG1 monoclonal antibody that binds c-Met with high affinity and is internalized efficiently — the same antibody that carries MMAE in Emrelis (telisotuzumab vedotin, ABBV-399). Reusing a clinically validated antibody de-risked the second-generation ADC: the question in AndroMETa is about the payload, not the targeting.

Linker-payload — the adizutecan platform: a topoisomerase 1 inhibitor (Top1i) attached through a cleavable valine-alanine dipeptide linker with a stable bromoacetamide attachment to the antibody. After c-Met-mediated internalization, lysosomal proteases cleave the dipeptide and release free payload, which stabilizes the topoisomerase 1–DNA complex, causes DNA double-strand breaks in replicating cells, and triggers apoptosis. The released payload is membrane-permeable, producing a bystander effect on adjacent c-Met-low tumor cells — the property that lets Top1i ADCs work in heterogeneous tumors.

How it compares with other Top1i ADCs: telisotuzumab adizutecan belongs to the same payload class as the deruxtecan (DXd) platform behind Enhertu (T-DXd), Datroway (Dato-DXd) and patritumab deruxtecan, and the SN-38 payload of Trodelvy — but with a different target (c-Met rather than HER2, TROP2 or HER3) and a different proprietary linker and payload chemistry. The practical consequence is a shared class toxicity profile (nausea, cytopenias, interstitial lung disease risk) and an open question about cross-resistance: whether tumors that progressed on one Top1i ADC remain sensitive to another with a different target. See the HER2 ADC hub and TROP2 ADC hub for the sibling platforms.

c-Met Testing: Overexpression vs Amplification vs Exon 14 Skipping

Three different MET abnormalities appear in trial eligibility criteria, and they are not interchangeable. Knowing which one your tumor has (or has been tested for) decides which telisotuzumab adizutecan trials — and which other MET drugs — are relevant:

c-Met protein overexpression (IHC): too much c-Met protein on the cell surface, measured by immunohistochemistry on a tumor biopsy and reported as a staining intensity (0 to 3+) and percentage of cells. This is the biomarker for c-Met ADCs — Emrelis's label requires high overexpression (3+ intensity in at least 50% of cells), and the telisotuzumab adizutecan NSCLC Breakthrough Therapy Designation and Phase 3 (NCT07821684) use a protocol-defined cutoff. Overexpression is common (roughly a quarter to a half of non-squamous NSCLC and colorectal cancers at some level) and usually occurs without any MET gene alteration.
MET amplification (NGS / FISH): extra copies of the MET gene, detected by next-generation sequencing or fluorescence in situ hybridization. Rare de novo (1–5% of NSCLC) but one of the most frequent acquired resistance mechanisms to osimertinib in EGFR-mutant NSCLC (roughly 10–15% of progressions). Amplified tumors usually have very high c-Met protein, which is why the tumor-agnostic Phase 2 (NCT07196644) and the post-osimertinib AndroMETa-Lung-713 trial (NCT07155187) are built around this group.
MET exon 14 skipping mutation (NGS): a splice-site mutation found in about 3–4% of NSCLC that produces a constitutively active receptor. This is the biomarker for MET kinase inhibitors (capmatinib, tepotinib), not for c-Met ADCs; exon 14 tumors are not the primary target of the AndroMETa program, although they may be eligible for some basket cohorts.

In practice: if you have colorectal cancer, ask whether c-Met IHC has been or can be run on your archival tissue (several AndroMETa colorectal trials select or stratify on it). If you have EGFR-mutant NSCLC progressing on osimertinib, ask for NGS or FISH for MET amplification — it opens both the telisotuzumab adizutecan trials and other MET-directed combinations. If you have EGFR wild-type NSCLC after chemo-immunotherapy, c-Met IHC is the relevant test, and the same result also determines Emrelis eligibility. See the NSCLC trials page and the Colorectal Cancer trials page for the broader biomarker-defined landscapes.

Sequencing and Comparison: Where Might Telisotuzumab Adizutecan Fit?

Because the drug is investigational, "fit" today means which trial population you match. The notes below describe the standard-of-care context of each setting so you can judge what the trial comparator represents.

Refractory metastatic colorectal cancer (third line and beyond): after FOLFOX / FOLFIRI (or FOLFOXIRI) with bevacizumab and, for RAS/BRAF wild-type tumors, anti-EGFR therapy, the approved options are LONSURF + bevacizumab (SUNLIGHT; median OS ~10.8 vs 7.5 months vs LONSURF alone), regorafenib, and fruquintinib — all modest. The Phase 3 NCT07525206 uses LONSURF + bevacizumab as its comparator, so enrolling means a 1-in-2 chance of the current best standard versus the ADC combination. Patients with MSI-H tumors, BRAF V600E, HER2 amplification or KRAS G12C have their own targeted options first; see the Colorectal Cancer trials page.
EGFR wild-type non-squamous NSCLC after platinum chemotherapy and immunotherapy: the standard is docetaxel, with or without ramucirumab — median PFS of roughly 4 months and OS around 10–12 months in most trials. Several ADCs are racing for this slot (Datroway missed its OS endpoint here in TROPION-Lung01; others are in Phase 3). Telisotuzumab adizutecan's Phase 3 (NCT07821684, not yet recruiting) uses docetaxel or ramucirumab as comparator and restricts to c-Met-expressing tumors. If your tumor has high c-Met overexpression, Emrelis is already approved in this setting and should be part of the conversation.
EGFR-mutant NSCLC: first-line osimertinib (or osimertinib + chemotherapy, or amivantamab + lazertinib) is standard; after progression, platinum/pemetrexed with or without amivantamab is standard. MET amplification at progression is the specific scenario where a c-Met ADC + osimertinib makes mechanistic sense, and AndroMETa-Lung-713 (NCT07155187) tests exactly that. The first-line combination (NCT07005102) is a bigger bet — adding an ADC to osimertinib in all comers to prevent resistance — with correspondingly more added toxicity to weigh.
Metastatic pancreatic ductal adenocarcinoma, first line: FOLFIRINOX / NALIRIFOX for fit patients and gemcitabine + nab-paclitaxel for the rest remain the standards, with median OS of roughly 11 months. AndroMETa-PDAC-288 (NCT07490301) replaces the irinotecan component with a c-Met-targeted Top1i payload on a FOLFOX backbone. Patients with KRAS G12C, BRCA/PALB2 or MSI-H alterations have targeted options that should be weighed alongside; see the Pancreatic Cancer trials page.
Frame fairly: ask your oncologist (a) whether c-Met IHC or MET amplification testing has been done and what it showed, (b) whether you meet the prior-therapy requirements of the relevant AndroMETa trial, (c) what the comparator arm would mean for you if randomized to it, and (d) whether Emrelis (approved) is an option before an investigational c-Met ADC if you have high-c-Met NSCLC.

Side Effects and Practical Considerations

⚠ Investigational Drug — No FDA Label, Safety Profile Still Being Defined

Telisotuzumab adizutecan has no FDA prescribing information. Its adverse-event profile is being characterized in the first-in-human study (NCT05029882), the Phase 2 dose-optimization trials, and the recruiting Phase 2/3 and Phase 3 trials. The information in this section describes the toxicity class of topoisomerase 1 inhibitor ADCs and known on-target effects of c-Met antibodies; it is not a list of verified incidence rates for this drug. Trial participants receive the current investigator's brochure summary from the study team, which supersedes anything here.

Interstitial lung disease (ILD) / pneumonitis is a recognized class risk for Top1i-payload ADCs (it carries a boxed warning on Enhertu and Datroway) and is monitored in AndroMETa protocols with baseline imaging, exclusion of patients with significant prior ILD, and dose hold or discontinuation rules. Report any new cough, shortness of breath or fever to the study team immediately.

Expected Top1i-Payload Class Effects

Nausea, vomiting, decreased appetite — the most common Top1i-ADC effects; managed with antiemetic prophylaxis.
Cytopenias — anemia, neutropenia and thrombocytopenia from payload released into circulation; monitored with regular blood counts, managed with dose delays or reductions and growth-factor support per protocol.
Fatigue and diarrhea — common and usually low-grade; diarrhea is a particular feature of SN-38-type payloads and is watched for with other Top1i payloads.
Transient liver enzyme elevations — typically reversible.
Alopecia — variable across Top1i ADCs; ask the trial team what has been observed.

What Changes Relative to Emrelis (MMAE Payload)

Emrelis's label warnings — peripheral neuropathy, ocular surface disorders, and infusion-related reactions — are largely driven by its MMAE payload and are not expected to carry over at the same magnitude to a Top1i-payload ADC, although infusion reactions can occur with any antibody. Conversely, Emrelis has a lower ILD signal than Top1i ADCs. Because the antibody is shared, on-target effects of c-Met binding on normal epithelium (for example, edema or hypoalbuminemia reported with some c-Met antibodies) may be common to both; these are being characterized in the trials.

Practical Considerations for Trial Participants

Tissue requirement: many AndroMETa trials require archival or fresh tumor tissue for c-Met IHC; ask early whether your pathology block is available.
Lung history: prior pneumonitis, interstitial lung disease or significant radiation fibrosis may exclude you; disclose it at screening.
Randomization: the Phase 3 and Phase 2/3 trials are open-label and randomized — you will know which arm you are on, and the comparator is the current standard of care, not placebo.
Visit burden: intravenous dosing every 2–3 weeks (schedule varies by trial and combination) with frequent labs in the first cycles.

Frequently Asked Questions

What is telisotuzumab adizutecan (Temab-A, ABBV-400)?

Telisotuzumab adizutecan (Temab-A; development code ABBV-400) is an investigational antibody-drug conjugate (ADC) from AbbVie that targets the c-Met protein (the MET receptor tyrosine kinase, also called the hepatocyte growth factor receptor), which is overexpressed in many solid tumors including colorectal, lung, gastric, pancreatic and head and neck cancers. It pairs telisotuzumab — the same humanized bivalent IgG1 anti-c-Met antibody used in the FDA-approved Emrelis (telisotuzumab vedotin) — with a topoisomerase 1 inhibitor (Top1i) payload attached via a cleavable valine-alanine linker on AbbVie's adizutecan platform, replacing the microtubule-inhibitor MMAE payload of Emrelis. Once the ADC binds c-Met and is internalized, the linker is cleaved and the Top1i payload damages tumor DNA during replication. Telisotuzumab adizutecan is being studied in AbbVie's AndroMETa program across colorectal, non-small cell lung, pancreatic, pancreatobiliary, head and neck and other solid tumors. As of October 2026 it has 12 recruiting interventional trials on ClinicalTrials.gov and is not yet FDA-approved.

Is telisotuzumab adizutecan FDA-approved? What do the two Breakthrough Therapy Designations mean?

No. Telisotuzumab adizutecan is not FDA-approved for any indication as of October 2026. On October 7, 2026 the FDA granted it two Breakthrough Therapy Designations (BTDs), its first: (1) in combination with bevacizumab for adults with refractory metastatic colorectal cancer previously treated with fluoropyrimidine, irinotecan, oxaliplatin, an anti-VEGF monoclonal antibody and, if indicated, an anti-EGFR monoclonal antibody; and (2) as monotherapy for adults with locally advanced or metastatic EGFR wild-type, c-Met protein-expressing, non-squamous NSCLC previously treated with platinum-based chemotherapy and an anti-PD-(L)1 antibody. A BTD means the FDA considers preliminary clinical evidence to show the drug may offer substantial improvement over available therapy on a clinically significant endpoint, and it commits the agency to intensive guidance and expedited review. It does not mean the drug is approved, available outside trials, or proven to extend survival — the confirmatory Phase 3 trials (NCT07525206 in colorectal cancer versus LONSURF plus bevacizumab; NCT07821684 in NSCLC versus docetaxel or ramucirumab) have not read out. For patients today, access is through a clinical trial.

How does telisotuzumab adizutecan differ from Emrelis (telisotuzumab vedotin)?

Both drugs use the same anti-c-Met antibody (telisotuzumab) but carry different payloads, which changes both their anticancer activity and their side-effect profile. Emrelis (telisotuzumab vedotin-tllv, ABBV-399) carries monomethyl auristatin E (MMAE), a microtubule inhibitor, and received FDA accelerated approval on May 14, 2025 for previously treated, locally advanced or metastatic non-squamous NSCLC with high c-Met protein overexpression, based on the LUMINOSITY trial. MMAE-payload ADCs characteristically cause peripheral neuropathy and ocular toxicity. Telisotuzumab adizutecan replaces MMAE with a topoisomerase 1 inhibitor (Top1i) payload on a cleavable valine-alanine linker — the same payload class as the deruxtecan (DXd) used in Enhertu and Datroway and the SN-38 used in Trodelvy. Top1i payloads act on DNA rather than microtubules, exert a bystander effect on neighboring tumor cells, and carry a different toxicity profile dominated by nausea, fatigue and cytopenias, with interstitial lung disease a class risk to monitor. Clinically, the two drugs are being developed in different populations: Emrelis is approved in high-c-Met NSCLC, whereas telisotuzumab adizutecan's Breakthrough Therapy Designations cover refractory metastatic colorectal cancer (with bevacizumab) and previously treated EGFR wild-type c-Met-expressing NSCLC, and it is also in Phase 2/3 trials in pancreatic cancer and EGFR-mutant NSCLC.

Who might be a candidate for a telisotuzumab adizutecan clinical trial?

The recruiting AndroMETa trials enroll several distinct patient groups, each with its own eligibility rules — ask your oncologist which, if any, fits your situation. (1) Refractory metastatic colorectal cancer after fluoropyrimidine, oxaliplatin, irinotecan and anti-VEGF (and anti-EGFR if RAS wild-type) therapy: the global Phase 3 NCT07525206 randomizes telisotuzumab adizutecan plus bevacizumab against LONSURF plus bevacizumab; a Phase 2 master protocol (NCT06820463) tests combinations with FOLFOX, bevacizumab and panitumumab. (2) Colorectal cancer that is ctDNA-positive after adjuvant therapy with no visible disease on scans: Phase 2 NCT07023289. (3) EGFR-mutant non-squamous NSCLC: first-line with osimertinib (NCT07005102) or after progression on a third-generation EGFR TKI such as osimertinib (NCT07155187, AndroMETa-Lung-713). (4) Non-squamous NSCLC without actionable mutations, first-line, with a PD-1 inhibitor (NCT06772623). (5) Newly diagnosed metastatic pancreatic ductal adenocarcinoma, first-line with FOLFOX (NCT07490301, AndroMETa-PDAC-288) or with gemcitabine/nab-paclitaxel in pancreatobiliary cancers (NCT07769502). (6) Recurrent or metastatic head and neck squamous cell carcinoma, first-line with pembrolizumab (NCT07744126). (7) Any locally advanced or metastatic solid tumor with MET amplification, age 12 or older (NCT07196644). Most trials require measurable disease, adequate organ function and no significant interstitial lung disease; several select or stratify on c-Met protein expression by immunohistochemistry, so tumor tissue may be needed.

What side effects are expected with telisotuzumab adizutecan?

Because telisotuzumab adizutecan has no FDA label, its safety profile is still being defined in the Phase 1 and Phase 2/3 trials; the information here describes the toxicity class of a topoisomerase 1 inhibitor (Top1i) ADC, not verified per-patient percentages for this drug. Top1i-payload ADCs (the same payload class as Enhertu, Datroway and Trodelvy) typically cause nausea, vomiting, decreased appetite, fatigue, diarrhea, and cytopenias (anemia, neutropenia, thrombocytopenia) from payload released into the circulation, and interstitial lung disease / pneumonitis is a monitored class risk that trial protocols screen for and manage with dose holds. The microtubule-inhibitor toxicities of Emrelis (peripheral neuropathy, ocular surface effects) are not expected to carry over because the payload is different, although on-target effects of the shared anti-c-Met antibody — c-Met is expressed on normal epithelium — may be shared. Trial participants are monitored with regular blood counts, liver tests and symptom checks, and should report new cough, shortness of breath or fever promptly. Ask the trial team for the current investigator's brochure summary of adverse events observed to date.

Find Telisotuzumab Adizutecan and c-Met-Targeted Trials Matched to Your Situation

Use ClinTrialFinder's AI-powered matching to find telisotuzumab adizutecan (Temab-A, ABBV-400) and other c-Met- and MET-directed trials based on your specific cancer type (colorectal, NSCLC, pancreatic, head and neck, gastroesophageal, hepatocellular), EGFR and MET biomarker status, prior lines of therapy, and country.

Find Matching Trials