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Last updated: June 18, 2026
A HER2 antibody-drug conjugate (ADC) is a monoclonal antibody that recognizes HER2 (human epidermal growth factor receptor 2, also called ERBB2) on the surface of cancer cells, chemically linked to a cytotoxic chemotherapy payload via a cleavable or non-cleavable linker. The antibody delivers the payload selectively to HER2-expressing tumor cells; once internalized, the payload is released and damages the cancer cell's DNA or microtubules. The ADC platform has three engineering variables that meaningfully differ between agents: antibody scaffold, linker chemistry (cleavable vs non-cleavable), and payload + drug-to-antibody ratio (DAR).
Two main payload classes in current HER2 ADCs:
HER2 status is required upfront. Eligibility depends on pathology HER2 IHC results (and ISH for IHC 2+ cases) on tumor tissue — usually the primary tumor block or a metastatic biopsy. Modern HER2 IHC has known interobserver variability, especially distinguishing IHC 1+ from IHC 0 and IHC 0 from IHC 0 with staining (the HER2-ultra-low category established by DESTINY-Breast06). Many trials require central HER2 IHC review. For HER2-mutant disease (an ERBB2 genomic alteration, separate from overexpression), next-generation sequencing on tumor or ctDNA is needed.
| Drug | Sponsor | Payload / DAR | Regulatory Status | Lead Recruiting Indications |
|---|---|---|---|---|
| T-DXd / Trastuzumab Deruxtecan (Enhertu, DS-8201) | AstraZeneca / Daiichi Sankyo | Deruxtecan (topo I inhibitor) / DAR ~8 / cleavable linker | FDA-approved: HER2+ breast, HER2-low breast, HER2-ultra-low breast, HER2+ gastric/GEJ, HER2-mutant NSCLC, HER2+ (IHC 3+) pan-tumor solid (accelerated approval Apr 2024). Readers should consult the current FDA prescribing information. | Breast (1L, neoadjuvant, brain mets), Gastric, NSCLC, Biliary, Endometrial, Ovarian, CRC, salivary basket, prostate. 82 corpus trials. |
| Disitamab Vedotin / RC48 (Aidixi) | RemeGen | MMAE (tubulin) / cleavable linker | NMPA-approved (China) for HER2+ urothelial cancer. Not FDA-approved. | Urothelial (1L Ph3 vs chemo+IO), Bladder (NMIBC + MIBC bladder preservation), Gastric/GEJ, Breast, Biliary, NSCLC, CRC, Cervical. 78 corpus trials. |
| SHR-A1811 / Trastuzumab Rezetecan | Hengrui Pharma (Jiangsu) | Topo I inhibitor / DAR ~6 / cleavable | Investigational. Phase 3 head-to-head vs T-DM1 in HER2+ breast (NCT06126640); Ph3 in HER2+ gastric (NCT06123494); Ph3 in HER2-mutant NSCLC (NCT06430437); Ph3 in ovarian (NCT06828354); Ph3 in TNBC (NCT07111832). | Breast (HER2+, HER2-low, HER2-ultra-low, TNBC, neoadjuvant, brain mets), Gastric, NSCLC (HER2-mutant), Ovarian, Biliary, Bladder. 64 corpus trials. |
| IBI354 | Innovent Biologics | Topo I inhibitor (deruxtecan-family) | Investigational. Phase 3 vs THP (taxane + trastuzumab + pertuzumab) in 1L HER2+ metastatic breast cancer (NCT07377643); Ph3 in platinum-resistant ovarian (NCT06834672). | Breast (1L HER2+ metastatic), Ovarian (platinum-resistant), pan-tumor Ph1/2. 3 corpus trials. |
| DP303c | Doer Biologics (Sino Biopharm subsidiary) | Topo I inhibitor | Investigational. Phase 3 vs T-DM1 in HER2+ advanced breast (NCT06313086). | Breast (HER2+ advanced), Gastric. 3 corpus trials. |
| ARX-788 | Ambrx / NovoCodex | MMAF (tubulin, non-cleavable, no bystander effect) | Investigational. Phase 2 in HER2+ metastatic breast post-T-DXd salvage (NCT06578286, NCT06663748); Ph2 in HER2-low breast (NCT06224673); Ph2 neoadjuvant + pyrotinib in breast (NCT04983121). | Breast (HER2+ post-T-DXd, HER2-low, neoadjuvant). 4 corpus trials. |
| MRG002 | Shanghai Miracogen | MMAE (tubulin) / cleavable | Investigational. Phase 3 vs investigator's choice of chemotherapy in HER2+ urothelial (NCT05754853). | Urothelial (Ph3 vs chemo), Cancer of Unknown Primary (Ph2). 2 corpus trials. |
| A166 | Sichuan Klus Pharma | Duo-5 (tubulin-binding) / cleavable | Investigational. Phase 2 in HER2+ unresectable or metastatic breast (NCT07299825). | Breast (HER2+). 1 corpus trial. |
What about trastuzumab duocarmazine (SYD985 / Byondis)? SYD985 received a Complete Response Letter from the FDA in May 2023 for HER2-positive metastatic breast cancer after T-DM1. The agent is not surfaced as actively recruiting in the ClinTrialFinder corpus as of June 18, 2026 and is not included on this hub. Readers should verify the latest SYD985 development status if interested.
What about T-DM1 (trastuzumab emtansine, Kadcyla)? T-DM1 is a 2013-approved HER2 ADC with an emtansine (DM1) payload that remains in active clinical use in the adjuvant and 2L+ HER2+ breast settings, but is not the focus of this hub. Several new HER2 ADCs are being tested head-to-head against T-DM1 as the established comparator (SHR-A1811 NCT06126640 in breast; DP303c NCT06313086 in HER2+ advanced breast), so T-DM1 appears in this hub as the comparator arm in the most consequential investigational Phase 3 trials. For T-DM1-specific information, consult the current FDA prescribing information.
The FDA-approved anchor with the broadest HER2 ADC label in oncology. Initial breast cancer approval December 2019; expanded to HER2-low December 2022 (DESTINY-Breast04); expanded to HER2-ultra-low January 2025 (DESTINY-Breast06); HER2+ gastric approval January 2021; HER2-mutant NSCLC approval August 2022; pan-tumor HER2+ (IHC 3+) accelerated approval April 2024 (DESTINY-PanTumor02). Deruxtecan topoisomerase I inhibitor payload with DAR ~8 and bystander effect — the molecular property that makes T-DXd work in HER2-low and HER2-ultra-low where T-DM1 and trastuzumab do not. Side-effect signal includes interstitial lung disease / pneumonitis (a class-defining and potentially fatal toxicity requiring CT-driven surveillance), nausea/vomiting, neutropenia, alopecia, fatigue, and infusion reactions. 82 ClinTrialFinder corpus trials — spanning 1L HER2+ breast (NCT05900206), brain metastases (NCT06088056), HER2-low maintenance (DESTINY-Endometrial01 NCT06989112 + NCT07022483), HER2+ biliary (NCT06467357 vs SoC), HER2+ NSCLC 1L (NCT06899126), HER2+ gastric 1L (NCT06731478), HER2-expressing ovarian maintenance (NCT06819007 / DESTINY-Ovarian01), HER2-expressing CRC, HER2+ urothelial, and HER2-expressing salivary gland (NCT05408845).
RemeGen's MMAE-payload HER2 ADC, NMPA-approved in China for HER2-positive locally advanced or metastatic urothelial cancer. Three Phase 3 trials in the ClinTrialFinder corpus: NCT05302284 (RC48 + toripalimab vs SOC in 1L urothelial), NCT07315750 (RC48 + trastuzumab + tislelizumab vs chemotherapy in HER2+ gastric/GEJ), and NCT05904964 (RC48 in HR+/HER2-low metastatic breast). Major program focus on HER2+ bladder cancer with a bladder-preservation strategy, where RC48 + IO is being tested as an alternative to cystectomy in multiple Phase 2 trials. 78 ClinTrialFinder corpus trials — bladder cancer NMIBC and MIBC dominate the not-yet-recruiting Chinese pipeline (16+ trials), urothelial 1L Ph3, HER2+ gastric/GEJ, HER2+ breast post-T-DXd salvage (NCT07065435 + bevacizumab/pyrotinib), HER2+ biliary (NCT07159217), HER2+ CRC, HER2+ cervical, HER2+ NSCLC with HER2 alterations.
Hengrui Pharma's topo I-payload HER2 ADC (deruxtecan-family, distinct chemistry from T-DXd). The agent is being tested head-to-head against established standards in five concurrent registrational Phase 3 trials: NCT06126640 (head-to-head vs T-DM1 in HER2+ breast — the definitive challenger trial), NCT06123494 (HER2+ gastric/GEJ adenocarcinoma), NCT06430437 (1L HER2-mutant advanced NSCLC), NCT06828354 (HER2-expressing ovarian cancer), and NCT07111832 (HER2-low TNBC). Plus NCT05814354 (Ph3 vs investigator's chemo in recurrent/metastatic breast), NCT07118527 (Ph3 + adebrelimab IO combo), and NCT07196774 (Ph3 neoadjuvant). 64 ClinTrialFinder corpus trials — the breast cancer Phase 2 pipeline is particularly deep, including brain-met trials (NCT06975462, NCT06975475, NCT07177950), suboptimal-neoadjuvant-response salvage (NCT07129187), and head-to-head vs T-DXd (NCT07416253).
Innovent's topo I-payload HER2 ADC, in two registrational Phase 3 trials in the ClinTrialFinder corpus: NCT07377643 (IBI354 ± pertuzumab vs taxane + trastuzumab + pertuzumab in 1L HER2+ metastatic breast — challenging the established THP standard of care) and NCT06834672 (IBI354 vs investigator's choice of chemotherapy in platinum-resistant ovarian, primary peritoneal, or fallopian tube cancer — an unusual HER2 ADC indication tracking the rising interest in HER2 expression in ovarian disease, paralleling T-DXd's NCT06819007 / DESTINY-Ovarian01). Plus NCT05636215 (Ph1/2 first-in-human pan-tumor). 3 ClinTrialFinder corpus trials, all RECRUITING.
Doer Biologics's topo I-payload HER2 ADC, in Phase 3 head-to-head vs T-DM1 (Kadcyla) in HER2+ advanced breast cancer (NCT06313086). The agent is being positioned as a T-DM1 successor in a parallel program to SHR-A1811 (which also has a vs-T-DM1 Phase 3 NCT06126640). Plus Ph3 NCT05901935 (HER2+ advanced breast) and Ph1/2 NCT06577376 (simmitinib or irinotecan liposomes + DP303c in gastric/GEJ). 3 ClinTrialFinder corpus trials.
Ambrx's MMAF-payload HER2 ADC. The non-cleavable MMAF linker means ARX-788 does not have a meaningful bystander effect — the agent is positioned for HER2+ disease specifically rather than HER2-low. The lead indications in the corpus are post-T-DXd salvage (NCT06578286: ARX788 in HER2+ MBC previously treated with T-DXd; NCT06663748: ARX788 in HER2+ MBC) and HER2-low breast (NCT06224673: ARX788 in HER2-low locally advanced or metastatic breast) and neoadjuvant breast + pyrotinib (NCT04983121). 4 ClinTrialFinder corpus trials.
Miracogen's MMAE-payload HER2 ADC. Phase 3 (NCT05754853): MRG002 vs investigator's choice of chemotherapy in HER2+ unresectable advanced or metastatic urothelial. Plus a Phase 2 trial (NCT06869174) in HER2+ Cancer of Unknown Primary (CUP) — an unusual HER2 ADC indication addressing the diagnostic / treatment gap in CUP patients with HER2 expression. 2 ClinTrialFinder corpus trials.
Klus Pharma's Duo-5-payload (tubulin-binding) HER2 ADC. Phase 2 (NCT07299825) in HER2+ unresectable or metastatic breast cancer. 1 ClinTrialFinder corpus trial.
The 149 recruiting (and 88 not-yet-recruiting) HER2 ADC trials are grouped below by primary cancer type. HER2 status (HER2-positive, HER2-low, HER2-ultra-low, or HER2-mutant) is required upfront — ask your oncologist for pathology HER2 IHC results before screening for any HER2 ADC trial.
The deepest HER2 ADC trial pool by far. T-DXd's established label spans 2L+ HER2+ MBC, brain mets, and neoadjuvant settings; the investigational Phase 3 pipeline (SHR-A1811, IBI354, DP303c) is concentrated here.
The DESTINY-Breast04 / DESTINY-Breast06 expansion that redefined which breast cancer patients can receive T-DXd. Multiple investigational Phase 3 trials test next-generation HER2 ADCs in HER2-low, plus combinations and post-T-DXd salvage.
HER2 ADC activity in CNS metastases is a clinically critical question. Multiple trials test T-DXd and SHR-A1811 with or without local CNS radiation.
T-DXd is FDA-approved for 2L+ HER2+ gastric (DESTINY-Gastric01); the 1L space is the most contested frontier, with three concurrent registrational trials adding T-DXd or HER2 ADCs to chemotherapy + pembrolizumab + trastuzumab backbones.
T-DXd is FDA-approved for HER2-mutant NSCLC (DESTINY-Lung01/02). Three registrational Phase 3 trials test 1L expansion and head-to-head challengers.
A small but rapidly developing HER2 ADC indication.
Disitamab vedotin's home court. NMPA-approved in China; Phase 3 in 1L vs IO + chemo. Plus an unusually deep Chinese pipeline of HER2 ADC bladder-preservation trials (RC48 + IO ± radiation as an alternative to cystectomy).
HER2 amplification is rare in CRC (~3-5%) but actionable. RC48 + tislelizumab combinations + T-DXd dominate this space.
A rapidly developing HER2 ADC indication, with two registrational Phase 3 T-DXd trials.
A newer HER2 ADC frontier. Two registrational Phase 3 trials and an unusual cross-class IBI354 Ph3 in platinum-resistant ovarian.
T-DXd received pan-tumor (HER2 IHC 3+) accelerated approval in April 2024 based on DESTINY-PanTumor02. The salivary gland HER2 basket and other rare HER2-expressing tumors fall under this umbrella.
The most clinically pressing real-world question for HER2 ADC use: what works after T-DXd progression? Multiple trials test sequencing strategies.
Showing 149 RECRUITING + 88 not-yet-recruiting HER2 ADC interventional trials in the ClinTrialFinder corpus as of June 18, 2026. T-DM1 (trastuzumab emtansine, Kadcyla, FDA-approved 2013) appears in this hub only as a comparator arm in head-to-head Phase 3 trials (SHR-A1811 NCT06126640, DP303c NCT06313086). HER2-targeted bispecifics (zanidatamab, KN026, ZW171), HER2 small-molecule TKIs (tucatinib, neratinib, lapatinib), non-ADC anti-HER2 antibodies (trastuzumab, pertuzumab, margetuximab), and HER2 vaccines / CAR-T are out of scope. For the latest searches: trastuzumab deruxtecan, disitamab vedotin, SHR-A1811, HER2 ADC.
HER2 ADCs are one of four HER2-directed treatment classes. The four-class comparison below frames where HER2 ADCs fit relative to the other anti-HER2 modalities:
| Class | Approved Drugs | Distinctive Side Effects | Where it fits |
|---|---|---|---|
| HER2 ADCs (this page) | T-DXd (Enhertu) — FDA-approved across HER2+ breast / HER2-low / HER2-ultra-low / HER2+ gastric / HER2-mutant NSCLC / HER2+ pan-tumor (Apr 2024). T-DM1 (Kadcyla) — FDA-approved 2013, persists in adjuvant + 2L+ HER2+ breast. Disitamab vedotin (RC48) — NMPA-approved (China) for HER2+ urothelial. | Interstitial lung disease / pneumonitis (T-DXd class signal, potentially fatal, requires CT surveillance), nausea/vomiting, neutropenia, alopecia, fatigue. T-DM1 carries thrombocytopenia + AST/ALT elevation. RC48 carries MMAE-class neuropathy + neutropenia + alopecia. | HER2+ disease across breast / gastric / NSCLC / pan-tumor (T-DXd label) + the HER2-low/ultra-low expansion via T-DXd. Adjuvant HER2+ breast residual disease (T-DM1, KATHERINE label). Post-T-DXd progression sequencing is the most pressing real-world question. |
| HER2 mAb backbone | Trastuzumab (Herceptin), pertuzumab (Perjeta), margetuximab (Margenza) | Cardiac dysfunction (LVEF decline — cumulative class signal), infusion reactions; pertuzumab adds diarrhea | The historical backbone of HER2+ breast and gastric care. THP (taxane + trastuzumab + pertuzumab) remains the 1L HER2+ MBC standard challenged by IBI354 Ph3 (NCT07377643). Adjuvant trastuzumab ± pertuzumab is the long-established curative backbone. Margetuximab is third-line. |
| HER2 small-molecule TKIs | Tucatinib (Tukysa), neratinib (Nerlynx), lapatinib (Tykerb) | Diarrhea (especially neratinib), rash, hand-foot syndrome, transaminitis; tucatinib has best CNS penetration | HER2+ MBC with brain metastases (tucatinib + trastuzumab + capecitabine, HER2CLIMB) is the established positioning. Extended adjuvant after trastuzumab (neratinib, ExteNET). Combinations with HER2 ADCs are tested (RC48 + pyrotinib). |
| HER2 bispecific antibodies (not on this hub) | Zanidatamab (HER2 × HER2 biparatopic) — FDA-approved (Ziihera) Nov 2024 in HER2+ biliary; KN026 (Alphamab) investigational | Diarrhea, infusion reactions, fatigue; cardiac monitoring as with all HER2-directed therapies | HER2+ biliary (zanidatamab, the only HER2 ADC-adjacent FDA-approved class outside this hub) + HER2+ gastric/breast investigational. Could become a future mechanism hub at /mechanisms/her2-bispecifics. |
How HER2 ADCs are positioned in practice. T-DXd has the broadest label and is the first choice for 2L+ HER2+ MBC (post-trastuzumab), HER2-low/ultra-low MBC, HER2+ gastric (post-trastuzumab), HER2-mutant NSCLC, and HER2+ pan-tumor solid (April 2024 accelerated approval). T-DM1 remains relevant in adjuvant HER2+ breast (residual disease post-neoadjuvant THP, KATHERINE) and as a 2L option where T-DXd hasn't been used. Disitamab vedotin is the lead HER2 ADC in urothelial (NMPA-approved) with a deep Chinese bladder-preservation pipeline. The investigational Chinese HER2 ADCs (SHR-A1811, IBI354, DP303c, MRG002, A166) are being positioned as T-DM1 successors (head-to-head challengers) and 1L HER2+ MBC alternatives to THP.
Cross-trial efficacy comparisons between T-DXd and emerging investigational HER2 ADCs — or between HER2 ADCs and HER2 bispecifics / HER2 TKIs — have not been validated in most head-to-head randomized trials and should not be inferred from separate single-arm studies. The choice of HER2-directed treatment sequence is a discussion with the patient's medical oncologist (and for gastric / GI cases, the GI oncologist).
HER2 ADCs carry a payload-driven cytotoxic signal distinct from the cardiac / infusion signals of trastuzumab + pertuzumab backbones:
By contrast, trastuzumab + pertuzumab carry cardiac LVEF / infusion signals; T-DXd's pneumonitis is the most patient-impactful new class signal of the last decade; tucatinib + capecitabine carries diarrhea + hand-foot syndrome. The HER2 ADC signal — ILD / pneumonitis + nausea + cytopenias on a HER2-confirmed patient — is class-distinctive and requires upfront patient education and clinical vigilance.
What is a HER2 antibody-drug conjugate (ADC)?
A HER2 antibody-drug conjugate is a monoclonal antibody that recognizes HER2 (human epidermal growth factor receptor 2, also called ERBB2) on the surface of cancer cells, chemically linked to a cytotoxic chemotherapy payload via a cleavable or non-cleavable linker. The antibody delivers the payload selectively to HER2-expressing tumor cells. Once internalized, the payload is released and damages the cancer cell's DNA or microtubules. T-DXd (trastuzumab deruxtecan, Enhertu) uses a deruxtecan payload (a topoisomerase I inhibitor — same class as irinotecan and topotecan) with a high drug-to-antibody ratio (~8) and the bystander effect that lets the payload diffuse to nearby HER2-negative cells. Disitamab vedotin (RC48) uses an MMAE (monomethyl auristatin E) tubulin-binding payload. ARX-788 uses MMAF. SHR-A1811 uses a topoisomerase I inhibitor similar to T-DXd. The choice of payload, linker, and drug-to-antibody ratio is what distinguishes the different agents in the class.
What's the difference between HER2-positive, HER2-low, and HER2-ultra-low?
HER2 expression is reported by immunohistochemistry (IHC) on a 0 to 3+ scale, with in-situ hybridization (ISH) for 2+ cases. HER2-positive means IHC 3+ OR IHC 2+ with positive ISH amplification — the classic 'HER2+' subset where trastuzumab and T-DM1 have worked for decades. HER2-low (a category established by DESTINY-Breast04 for T-DXd) means IHC 1+ OR IHC 2+ with negative ISH — historically considered HER2-negative for trastuzumab purposes, but T-DXd works here. HER2-ultra-low (established by DESTINY-Breast06) means IHC 0 with some HER2 staining at any membrane — the newest expansion of the T-DXd label. Many emerging HER2 ADC trials enroll across HER2-positive AND HER2-low/ultra-low together because the deruxtecan-payload ADCs deliver enough cytotoxic via the bystander effect even at low expression. For HER2+ status confirmation you need pathology IHC ± ISH on tumor tissue — typically the primary tumor block or a metastatic biopsy. Some trials also accept HER2 amplification by next-generation sequencing or HER2-mutant disease (separate from overexpression).
Is T-DXd (Enhertu) approved for my cancer?
T-DXd (trastuzumab deruxtecan, Enhertu, AstraZeneca / Daiichi Sankyo) is FDA-approved for: (1) unresectable or metastatic HER2-positive breast cancer after one or more prior anti-HER2-based regimens (DESTINY-Breast03 / DESTINY-Breast02); (2) unresectable or metastatic HER2-low breast cancer (IHC 1+ or IHC 2+/ISH-negative) — DESTINY-Breast04; (3) unresectable or metastatic HER2-ultra-low breast cancer (IHC 0 with HER2 staining) — DESTINY-Breast06 expansion; (4) HER2-positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma after prior trastuzumab-based regimen — DESTINY-Gastric01; (5) HER2-mutant unresectable or metastatic NSCLC — DESTINY-Lung01/02; (6) HER2-positive (IHC 3+) unresectable or metastatic solid tumors that have progressed after prior systemic therapy and have no satisfactory alternative — accelerated approval April 2024 based on DESTINY-PanTumor02. Disitamab vedotin (RC48) has NMPA approval in China for HER2-positive urothelial cancer (not FDA-approved). All other HER2 ADCs (SHR-A1811, IBI354, DP303c, ARX-788, MRG002, A166) are investigational. Readers should consult the current FDA prescribing information for the most up-to-date label.
What if my HER2 status is IHC 0 (HER2-zero) or unknown?
DESTINY-Breast06 expanded the T-DXd label into HER2-ultra-low breast cancer (IHC 0 with some membrane HER2 staining at any intensity) — so 'HER2 IHC 0 with staining' is a distinct category from 'HER2-zero / HER2-null' (no detectable HER2 staining whatsoever). Some emerging trials are testing T-DXd and other HER2 ADCs in HER2-zero IHC 0 patients to see if cytotoxic payload activity persists below detection threshold; NCT05950945 is a Phase 3 T-DXd trial enrolling both HER2-low and HER2 IHC 0 patients. If HER2 status is unknown, IHC testing on the most recent tumor tissue (primary or metastatic biopsy) is required before HER2 ADC eligibility can be established. Modern HER2 IHC has known interobserver variability, especially distinguishing IHC 1+ from IHC 0 and IHC 0 from IHC 0 with staining — many trials require central HER2 IHC review. For HER2-mutant disease (a separate category from HER2 expression — a genomic alteration in the ERBB2 gene), next-generation sequencing on tumor or ctDNA is needed.
Are there HER2 ADCs available besides T-DXd?
T-DXd is the FDA-approved anchor across HER2+ breast, HER2-low/ultra-low breast, HER2+ gastric, HER2+ NSCLC, and HER2-mutant pan-tumor. Disitamab vedotin (RC48 / Aidixi, RemeGen) is NMPA-approved in China for HER2-positive urothelial cancer (not FDA-approved); Phase 3 trials are open globally in HER2+ gastric (NCT07315750) and HER2+ first-line urothelial (NCT05302284). The other 6 HER2 ADCs are all investigational: SHR-A1811 / Trastuzumab Rezetecan (Hengrui Pharma) has the largest investigational pipeline with Phase 3 head-to-head vs T-DM1 in HER2+ breast (NCT06126640), Ph3 in HER2+ gastric (NCT06123494), and Ph3 in HER2-mutant NSCLC (NCT06430437); IBI354 (Innovent) has Phase 3 in HER2+ breast vs taxane+trastuzumab+pertuzumab (NCT07377643) and Ph3 in platinum-resistant ovarian (NCT06834672); DP303c (Doer Biologics) has Phase 3 vs T-DM1 in HER2+ breast (NCT06313086); ARX-788 (Ambrx) is in Phase 2 for post-T-DXd salvage and HER2-low; MRG002 (Miracogen) has Phase 3 in HER2+ urothelial vs chemo (NCT05754853); A166 (Klus Pharma) is in Phase 2 for HER2+ breast (NCT07299825). Multiple Chinese-developed agents are entering global trials, often head-to-head against T-DXd or T-DM1.
How do I find a HER2 ADC clinical trial that fits my situation?
Use ClinTrialFinder's AI-powered matching to surface HER2 ADC trials based on your specific situation — primary cancer type (breast, gastric, NSCLC, biliary, urothelial, CRC, endometrial, ovarian, salivary), HER2 status (IHC 3+, IHC 2+/ISH amp, IHC 2+/ISH-, IHC 1+, IHC 0 with staining, IHC 0, HER2-mutant), hormone receptor status (HR+/HR-, triple-negative), prior therapy (treatment-naive, prior trastuzumab, prior T-DM1, prior T-DXd, post-T-DXd salvage), line of therapy (neoadjuvant, adjuvant, 1L metastatic, 2L+, post-progression), brain metastases status (several brain-met-specific trials open), and country. Use the patient-match button below to enter the disease-specific matching wizard. Before eligibility can be established, you'll need pathology HER2 IHC results (and ISH for IHC 2+ cases) — ask your oncologist for the most recent tumor block to confirm HER2 status. For the broader disease-specific trial landscapes including HER2 ADCs alongside other classes, see the matching disease pages: /trials/breast-cancer, /trials/gastric-cancer, /trials/lung-cancer-nsclc, /trials/cholangiocarcinoma, /trials/bladder-cancer, /trials/colorectal-cancer.
Find Matching HER2 ADC Trials
Use ClinTrialFinder's AI-powered matching to find T-DXd, disitamab vedotin, SHR-A1811, IBI354, DP303c, ARX-788, MRG002, and A166 trials based on your cancer type, HER2 IHC status, prior therapy history, and country.
Find Matching HER2 ADC TrialsThis page is for information only and is not medical advice. ClinTrialFinder helps you find clinical trials that may match your situation, but enrollment decisions and treatment choices should always be made with your medical oncologist (and for gastric / GI cases, the GI oncologist). Trial eligibility, recruitment status, and treatment details can change — verify directly with the trial sponsor or on ClinicalTrials.gov before acting on any information here. FDA approval dates and indications are summarized for context only; consult the current FDA prescribing information for each drug for authoritative regulatory status.