12 Rilvegostomig (AZD2936) Clinical Trials Recruiting Now (May 2026): NSCLC, Biliary, Gastric, HCC, Endometrial — PD-1/TIGIT Bispecific (AstraZeneca) — DESTINY-BTC01, AB02, ARTEMIDE, TROPION-Lung10

Last updated: May 31, 2026

🗓️ Investigational status: As of May 2026, rilvegostomig is not yet approved by any regulatory agency. Access is available only through enrollment in one of the ongoing clinical trials listed below. ASCO 2026 (May 29 — June 2) may include interim data presentations or trial-in-progress posters from several of these Phase 3 programs.

About Rilvegostomig

Drug profile:

Rilvegostomig (development code AZD2936) is an investigational bispecific antibody developed by AstraZeneca. It simultaneously blocks two distinct inhibitory receptors on T cells and natural killer cells: PD-1 (Programmed Death-1, the same checkpoint targeted by pembrolizumab, nivolumab, cemiplimab) and TIGIT (T-cell immunoreceptor with Ig and ITIM domains).

Mechanism of action:

PD-1 and TIGIT use non-overlapping pathways to suppress anti-tumor immunity. PD-1 signaling exhausts T cells via the PD-L1 ligand in the tumor microenvironment; TIGIT signaling separately dampens both T-cell and NK-cell activation via CD155 and CD112 ligands. The therapeutic hypothesis is that simultaneously blocking both checkpoints with a single bispecific molecule may produce deeper and more durable responses than blocking PD-1 alone — particularly in tumor types where PD-1 monotherapy plateaus around 20-40% response rates. The same therapeutic concept is being pursued by separate-molecule combinations (e.g., vibostolimab + pembrolizumab from Merck, tiragolumab + atezolizumab from Roche/Genentech), but rilvegostomig is designed as one molecule for simplified dosing and potentially better tumor-selective activity.

Regulatory status:

As of May 2026, rilvegostomig has no regulatory approvals anywhere in the world. The development program is in Phase 3 confirmatory trials across NSCLC (4 trials), biliary tract cancer (2), HER2-positive gastric/GEJ cancer, Claudin 18.2-positive gastric/GEJ/esophageal cancer, hepatocellular carcinoma, and endometrial cancer. The earliest pivotal readouts are expected over 2026-2027 depending on event accrual; the first regulatory submissions would follow positive Phase 3 results.

Active Research Directions in 2026

Non-small-cell lung cancer (NSCLC) — 4 trials, all 4 Phase 3 head-to-head against pembrolizumab. Includes monotherapy comparisons (TROPION-Lung10 vs pembrolizumab mono + Dato-DXd combination arm; ARTEMIDE-Lung04 vs pembrolizumab mono) and chemo-combination comparisons (ARTEMIDE-Lung02 squamous; ARTEMIDE-Lung03 non-squamous). NSCLC is the largest indication cluster.
Biliary tract cancer — 2 Phase 3 trials (DESTINY-BTC01 with T-DXd in HER2-expressing BTC; AB02 / ARTEMIDE-Biliary02 vs durvalumab + chemo) plus 2 not-yet-recruiting perioperative/neoadjuvant studies in resectable intrahepatic cholangiocarcinoma (NEOLANGIO, PEHRICCA).
HER2-positive gastric / GEJ cancer — Phase 3 with T-DXd backbone (D702AC00001), combining the dual checkpoint approach with the most active HER2-targeted ADC.
Claudin 18.2-positive gastric / GEJ / esophageal cancer — Phase 3 with sonesitatug vedotin + capecitabine (D9803C00001). Sonesitatug vedotin is a Claudin 18.2-targeted ADC; this trial expands rilvegostomig into the HER2-negative, Claudin18.2-positive biomarker subset.
Hepatocellular carcinoma — ARTEMIDE-HCC01 Phase 3 evaluating rilvegostomig + bevacizumab ± tremelimumab vs atezolizumab + bevacizumab (the IMbrave150 1L SoC).
Endometrial cancer — DESTINY-Endometrial01 Phase 3 combining rilvegostomig + T-DXd vs T-DXd + pembrolizumab vs carboplatin + paclitaxel + pembrolizumab in HER2-expressing (IHC 3+/2+), pMMR primary advanced or recurrent endometrial cancer.
Subcutaneous formulation development — ARTEMIDE-subQ Phase 1 in advanced solid tumors testing the SC formulation pharmacokinetics and safety, supporting a future patient-friendly administration option.
Head and neck squamous cell carcinoma — intratumoral microdosing (PBI-MST-01 substudy AZN-05) testing rilvegostomig alongside 3 other AZ investigational agents (volrustomig PD-1×CTLA-4, sabestomig PD-1×LAG-3, AZD9592 EGFR/MET ADC) via the Presage Biosciences CIVO microdosing platform.

Recruiting Trials by Indication

Non-Small Cell Lung Cancer (NSCLC) — 4 trials, 4 Phase 3

The largest rilvegostomig indication cluster, with multiple head-to-head Phase 3 trials against pembrolizumab combinations:

NCT06357533 — TROPION-Lung10, Phase 3 3-arm study of Dato-DXd (datopotamab deruxtecan, TROP2 ADC) + rilvegostomig, rilvegostomig monotherapy, or pembrolizumab monotherapy in 1L NSCLC. Restricted to PD-L1-high (TC ≥ 50%), non-squamous, without actionable genomic alterations. First-line head-to-head test of TROP2 ADC + PD-1/TIGIT vs pembrolizumab.
NCT06627647 — D702FC00001 / ARTEMIDE-Lung03, Phase 3 rilvegostomig or pembrolizumab + platinum-based chemotherapy in 1L non-squamous metastatic NSCLC whose tumors express PD-L1.
NCT06692738 — D702BC00001 / ARTEMIDE-Lung02, Phase 3 rilvegostomig or pembrolizumab + platinum-based chemotherapy in 1L metastatic squamous NSCLC whose tumors express PD-L1.
NCT06868277 — ARTEMIDE-Lung04, Phase 3 rilvegostomig or pembrolizumab monotherapy in 1L PD-L1-high metastatic NSCLC (no chemotherapy backbone).

Biliary Tract Cancer — 2 RECRUITING Phase 3 + 2 NOT_YET_RECRUITING perioperative

Biliary cancer is one of the highest-priority rilvegostomig indications, with combinations spanning HER2-expressing and broader BTC populations:

NCT06467357 — DESTINY-Biliary Tract Cancer-01, Phase 3 3-arm comparison: (A) T-DXd (trastuzumab deruxtecan) + rilvegostomig vs (B) T-DXd monotherapy vs (C) standard-of-care gemcitabine + cisplatin + durvalumab (the TOPAZ-1 regimen) in 1L HER2-expressing biliary tract cancer.
NCT07221253 — AB02 / ARTEMIDE-Biliary02, Phase 3 rilvegostomig or durvalumab plus gemcitabine + cisplatin in 1L biliary tract cancer. Direct head-to-head AstraZeneca-internal comparison of the new bispecific vs the established PD-L1 inhibitor durvalumab on top of chemotherapy.
NCT06569225 — NEOLANGIO, Phase 2 (not-yet-recruiting) Gemcitabine/Cisplatin/Nab-Paclitaxel + rilvegostomig in resectable intrahepatic cholangiocarcinoma (University Health Network Toronto, perioperative).
NCT07128290 — PEHRICCA, Phase 2 (not-yet-recruiting) Perioperative CISGEM + rilvegostomig in high-risk resectable iCCA (FFCD France).

HER2-Positive Gastric / GEJ Cancer — Phase 3 with T-DXd

NCT06764875 — D702AC00001, Phase 3 rilvegostomig + fluoropyrimidine + T-DXd vs trastuzumab + chemotherapy + pembrolizumab in 1L HER2-positive, PD-L1 CPS ≥ 1 locally advanced or metastatic gastric / gastroesophageal junction adenocarcinoma. Tests dual-checkpoint + HER2-ADC + fluoropyrimidine vs the current trastuzumab + chemo + pembro standard.

Gastric / GEJ / Esophageal Cancer (HER2-negative, Claudin 18.2-positive) — Phase 3

NCT07431281 — D9803C00001, Phase 3 sonesitatug vedotin + capecitabine ± rilvegostomig in Claudin 18.2-positive, HER2-negative gastric / GEJ / esophageal adenocarcinoma. Sonesitatug vedotin is a Claudin 18.2-targeted ADC (Claudin 18.2 is a tight-junction protein normally restricted to gastric epithelium that becomes accessible on gastric/GEJ/esophageal tumor surfaces); combining with rilvegostomig tests whether dual checkpoint blockade adds to ADC-based approaches in this biomarker-defined population.

Hepatocellular Carcinoma (HCC) — Phase 3 with bevacizumab

NCT06921785 — ARTEMIDE-HCC01, Phase 3 3-arm: (A) rilvegostomig + bevacizumab vs (B) rilvegostomig + bevacizumab + tremelimumab vs (C) atezolizumab + bevacizumab (current 1L SoC per IMbrave150) in advanced HCC not amenable to curative or locoregional therapy. Tests dual-checkpoint + anti-VEGF approach against the established atezo+bev standard, with an optional CTLA-4 addition arm.

Endometrial Cancer — DESTINY-Endometrial01 Phase 3

NCT06989112 — DESTINY-Endometrial01 / DE-01, Phase 3 3-arm comparison: (A) T-DXd + rilvegostomig vs (B) T-DXd + pembrolizumab vs (C) carboplatin + paclitaxel + pembrolizumab in 1L HER2-expressing (IHC 3+/2+), mismatch repair proficient (pMMR) primary advanced (Stage III/IV) or recurrent endometrial cancer.

Phase 1 Programs

NCT07161414 — ARTEMIDE-subQ, Phase 1 subcutaneous rilvegostomig pharmacokinetics and safety in advanced solid tumors. Supports a future patient-friendly SC-injection administration option vs IV infusion.
NCT06366451 — PBI-MST-01 substudy AZN-05, Phase 1 (technically Phase 0 per the official title) intratumoral microdosing of 4 AstraZeneca investigational agents: rilvegostomig (PD-1 × TIGIT), volrustomig (PD-1 × CTLA-4), sabestomig (PD-1 × LAG-3), and AZD9592 (EGFR/MET ADC). Tested in HNSCC patients with surface-accessible lesions via the Presage Biosciences CIVO device, allowing localized in-tumor pharmacodynamic measurement at microdose quantities.

Showing all 12 recruiting rilvegostomig trials plus 2 not-yet-recruiting Phase 2 perioperative iCCA studies in setup. The development program is heavily AstraZeneca-sponsored (11 of 12 recruiting trials; the lone non-AZ trial is a Phase 1 intratumoral-microdosing program from Presage Biosciences on the AZN-05 substudy). View the latest on ClinicalTrials.gov.

Patient Selection and Biomarkers

HER2 expression — required for DESTINY-BTC01 (HER2-expressing biliary tract), D702AC00001 (HER2-positive gastric/GEJ with PD-L1 CPS ≥ 1), and DESTINY-Endometrial01 (HER2-expressing IHC 3+/2+ endometrial). HER2 IHC/ISH/FISH status determines eligibility.
PD-L1 expression — central to the NSCLC program: TROPION-Lung10 and ARTEMIDE-Lung04 require PD-L1-high (TC ≥ 50%); ARTEMIDE-Lung02 (squamous) and ARTEMIDE-Lung03 (non-squamous) require PD-L1-expressing tumors (specific threshold defined in trial protocol). D702AC00001 requires PD-L1 CPS ≥ 1.
Mismatch repair status — DESTINY-Endometrial01 is restricted to pMMR (mismatch repair proficient) endometrial cancer. The dMMR/MSI-H endometrial population, which has high response rates to single-agent PD-1 inhibitors (dostarlimab, pembrolizumab), is excluded from this trial.
Claudin 18.2 expression — required for D9803C00001 (gastric/GEJ/esophageal adenocarcinoma). The trial selects HER2-negative and Claudin18.2-positive tumors. Claudin 18.2 (CLDN18.2) is a tight-junction protein normally restricted to gastric epithelium that becomes accessible on gastric/GEJ/esophageal tumor surfaces.
Actionable genomic alterations — TROPION-Lung10 specifically excludes NSCLC with actionable driver mutations (EGFR, ALK, ROS1, etc.) since those are treated with targeted therapy first.
Histology and stage — ARTEMIDE-Lung02 vs ARTEMIDE-Lung03 are differentiated by squamous vs non-squamous histology. The resectable iCCA studies (NEOLANGIO, PEHRICCA) require resectable disease with high-risk features; advanced/metastatic studies require unresectable or stage IV disease.
Prior therapy — most rilvegostomig trials are 1L (first-line) studies, reflecting AstraZeneca's strategy of testing dual checkpoint blockade as front-line standard-of-care. Patients with prior immunotherapy exposure are generally excluded.

Side Effects and Practical Considerations

Immune-related events (PD-1 axis) — fatigue, skin rash, hypothyroidism and other endocrinopathies, immune-mediated colitis, hepatitis, pneumonitis. Pre-existing autoimmune disease warrants careful pre-treatment evaluation.
TIGIT-axis adverse events — the broader anti-TIGIT class has shown infusion reactions, fatigue, and pruritus as commonly reported events in other PD-1/TIGIT programs (e.g., vibostolimab + pembrolizumab from Merck; tiragolumab + atezolizumab from Roche). Rilvegostomig trials will inform the specific TIGIT-related adverse-event profile of this molecule.
Combination toxicities — the indication-specific combinations add their own toxicities: chemotherapy adds myelosuppression and neuropathy; T-DXd adds nausea and pneumonitis; bevacizumab adds hypertension and bleeding; sonesitatug vedotin adds peripheral neuropathy.
Tremelimumab arm (ARTEMIDE-HCC01) — the optional CTLA-4 addition arm carries the higher autoimmune toxicity profile of CTLA-4 inhibition (immune-mediated colitis and hepatitis are most concerning).
Investigational caveat — rilvegostomig is investigational. The safety database is smaller than for approved checkpoint inhibitors, and full Phase 3 toxicity readouts are still pending.

Frequently Asked Questions

What is rilvegostomig?

Rilvegostomig (development code AZD2936) is an investigational bispecific antibody from AstraZeneca that simultaneously blocks PD-1 (an immune checkpoint on T cells) and TIGIT (T-cell immunoreceptor with Ig and ITIM domains, an inhibitory receptor on T cells and natural killer cells). The rationale is that PD-1 and TIGIT use non-overlapping pathways to suppress anti-tumor immunity, so blocking both may produce deeper and more durable responses than PD-1 alone. As of May 2026, rilvegostomig has no regulatory approvals — it is investigational, currently in 10 Phase 3 trials across NSCLC, biliary tract, HER2-positive gastric/GEJ, HCC, and endometrial cancer.

How is rilvegostomig different from durvalumab?

Both are AstraZeneca checkpoint products, but they target different molecules and serve different roles. Durvalumab (brand name Imfinzi) is a single-antibody anti-PD-L1 inhibitor, already approved in multiple cancer types including NSCLC, biliary tract cancer (TOPAZ-1 regimen), HCC, and bladder cancer. Rilvegostomig is a single bispecific molecule blocking both PD-1 and TIGIT. The two are being developed as separate clinical assets, not replacements for one another. In the AB02 Phase 3 trial in biliary tract cancer, AstraZeneca is comparing rilvegostomig + chemotherapy directly against durvalumab + chemotherapy to determine whether the TIGIT addition improves outcomes over PD-L1 inhibition alone.

Is rilvegostomig the same as ivonescimab?

No. Rilvegostomig and ivonescimab are different bispecific antibodies from different companies, targeting different pathway combinations. Rilvegostomig (AstraZeneca, AZD2936) targets PD-1 plus TIGIT. Ivonescimab (Akeso / Summit Therapeutics, AK112) targets PD-1 plus VEGF. The PD-1 arm is shared, but the second targets are mechanistically different: TIGIT is another immune-checkpoint receptor on T cells and NK cells (like PD-1), while VEGF is the angiogenesis signal tumors use to grow blood vessels. Side-effect profiles, clinical positioning, and ideal patient populations differ accordingly. If you are searching for ivonescimab (AK112) trials, those are sponsored by Akeso / Summit Therapeutics, not AstraZeneca — see our ivonescimab page for that program.

What rilvegostomig trials are currently recruiting?

12 recruiting interventional rilvegostomig trials as of May 2026, plus 2 not-yet-recruiting in setup. All but one are sponsored by AstraZeneca. 10 are Phase 3 pivotal studies across: NSCLC (4 trials — TROPION-Lung10 with Dato-DXd; ARTEMIDE-Lung04 monotherapy vs pembrolizumab; ARTEMIDE-Lung03 / D702FC00001 non-squamous + ARTEMIDE-Lung02 / D702BC00001 squamous with chemo); biliary tract cancer (2 — DESTINY-BTC01 with T-DXd in HER2-expressing BTC; AB02 / ARTEMIDE-Biliary02 vs durvalumab + chemo); HER2-positive gastric/GEJ (D702AC00001 with fluoropyrimidine + T-DXd); Claudin 18.2-positive gastric/GEJ/esophageal (D9803C00001 with sonesitatug vedotin + capecitabine); HCC (ARTEMIDE-HCC01 with bevacizumab ± tremelimumab vs atezolizumab + bev); and endometrial cancer (DESTINY-Endometrial01 with T-DXd in HER2-expressing pMMR). Two Phase 1 trials cover subcutaneous formulation pharmacokinetics (ARTEMIDE-subQ) and intratumoral microdosing in HNSCC (PBI-MST-01 AZN-05 substudy, also testing volrustomig + sabestomig + AZD9592).

What are the main side effects of rilvegostomig?

As an investigational drug, rilvegostomig's full safety profile is still emerging from ongoing trials. Expected side effects combine immune-related events from both checkpoint targets: from the PD-1 arm — fatigue, skin rash and pruritus, hypothyroidism and other endocrinopathies, immune-mediated colitis, hepatitis, pneumonitis; from the TIGIT arm — the broader anti-TIGIT class has shown infusion reactions, fatigue, and pruritus as common events in other PD-1/TIGIT combination programs. Some PD-1/TIGIT programs from other sponsors have raised questions about whether dual checkpoint blockade increases immune-related adverse events beyond PD-1 alone; rilvegostomig trials will inform this for this specific molecule. Combination-specific toxicities: chemotherapy adds myelosuppression and neuropathy; T-DXd adds nausea and pneumonitis; bevacizumab adds hypertension and bleeding.

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