Investigational Drug
Rilvegostomig
TrialFetch AI Analysis
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Overview
Rilvegostomig (AZD2936) is an investigational bispecific immune-checkpoint antibody being developed for solid tumors, most extensively studied in non-small-cell lung cancer (NSCLC). Clinical evidence remains preliminary and largely comes from the nonrandomized phase I/II ARTEMIDE-01 trial; randomized phase III NSCLC studies are ongoing. (pubmed.ncbi.nlm.nih.gov)
Mechanism of action
Rilvegostomig is a humanized IgG1 antibody that simultaneously targets PD-1 and TIGIT, inhibitory receptors found on T cells and natural killer cells. Dual blockade is intended to restore antitumor immune activity more effectively than inhibition of either pathway alone. Its Fc region contains three mutations designed to minimize Fc-mediated immune-effector activity. (ascopubs.org)
Efficacy
In checkpoint-inhibitor–experienced, PD-L1-positive advanced NSCLC, ARTEMIDE-01 established 750 mg intravenously every three weeks as the recommended phase II dose. Among patients treated at this dose, the objective response rate (ORR) was 5.6%, the six-month disease-control rate was 31.5%, and median progression-free survival (PFS) was 3.8 months. (pubmed.ncbi.nlm.nih.gov)
Updated results in 65 checkpoint-inhibitor–naïve patients receiving 750 mg every three weeks showed:
- PD-L1 TPS 1–49%: ORR 29.0% (9/31), median duration of response 9.9 months, and median PFS 6.1 months.
- PD-L1 TPS ≥50%: ORR 61.8% (21/34), including one complete response; median PFS was 12.3 months, while median duration of response was not yet reached.
These single-arm results cannot establish whether rilvegostomig is superior to currently available checkpoint inhibitors. (annalsofoncology.org)
Safety
In 83 checkpoint-inhibitor–experienced patients, 54.2% experienced a treatment-related adverse event, including 8.4% with grade 3 events; no dose-limiting toxicities were observed, and 2.4% discontinued because of treatment-related toxicity. Immune-mediated adverse events occurred in 18.1%. (pubmed.ncbi.nlm.nih.gov)
Among the 65 checkpoint-inhibitor–naïve patients in the later analysis, grade 3 treatment-related adverse events occurred in 12.3%, treatment-related discontinuations in 3.1%, and no grade 4 or 5 treatment-related events were reported. (annalsofoncology.org)
Further reading
- Peer-reviewed first-in-human ARTEMIDE-01 report (PubMed)
- Updated ARTEMIDE-01 results in checkpoint-inhibitor–naïve NSCLC
- ARTEMIDE-01 trial registration
- 2024 World Conference on Lung Cancer abstract book
Last updated: Sep 2026
Active trials using Rilvegostomig
Found 17 active trials using this drug:
TrialFetch AI summary: Adults with previously untreated, unresectable or metastatic CLDN18.2-positive, HER2-negative gastric, gastroesophageal junction, or distal esophageal adenocarcinoma receive first-line treatment according to PD-L1 status and checkpoint-inhibitor eligibility. The study compares capecitabine plus sonesitatug vedotin, a CLDN18.2-directed antibody–drug conjugate, with or without rilvegostomig, a PD-1/TIGIT-blocking antibody, against nivolumab-based chemotherapy or zolbetuximab-based or oxaliplatin-based chemotherapy.
ClinicalTrials.gov ID: NCT07431281
TrialFetch AI summary: This trial enrolls patients with previously untreated, unresectable locally advanced or metastatic cholangiocarcinoma or gallbladder adenocarcinoma and ECOG performance status 0–1. It compares first-line gemcitabine/cisplatin plus rilvegostomig, an investigational PD-1/TIGIT bispecific antibody, with gemcitabine/cisplatin plus durvalumab.
ClinicalTrials.gov ID: NCT07221253
TrialFetch AI summary: Adults with locally advanced or metastatic NSCLC and ECOG 0–1 are enrolled in first-line cohorts without known actionable alterations (PD-L1 ≥1%) or a second-line nonsquamous cohort with actionable alterations after progression on targeted therapy. First-line treatment is rilvegostomig (a PD-1/TIGIT bispecific antibody) with or without ramucirumab (anti-VEGFR2), depending on PD-L1 expression; second-line treatment is datopotamab deruxtecan (a TROP2-directed, topoisomerase I inhibitor–delivering antibody–drug conjugate) plus ramucirumab, with or without rilvegostomig.
ClinicalTrials.gov ID: NCT07098338
TrialFetch AI summary: Adults with ECOG 0–1 and selected advanced or metastatic solid tumors receive AZD6750, an investigational CD8-guided IL-2 agent designed to preferentially stimulate CD8-positive T cells. A separate cohort of patients with stage IV NSCLC receives AZD6750 plus rilvegostomig, an investigational PD-1/TIGIT bispecific antibody.
ClinicalTrials.gov ID: NCT07115043
TrialFetch AI summary: For adults with previously untreated stage IV squamous or nonsquamous NSCLC, PD-L1 TPS ≥1%, and no actionable alteration with approved first-line targeted therapy, this study evaluates rilvegostomig, an investigational PD-1/TIGIT bispecific antibody, combined with either AB248, a CD8-targeted IL-2 fusion protein, or platinum-based chemotherapy. Chemotherapy combinations include ramucirumab (anti-VEGFR2) in the squamous expansion cohort and are tested with or without it in nonsquamous disease.
ClinicalTrials.gov ID: NCT06996782
TrialFetch AI summary: Adults with previously untreated, unresectable locally advanced or metastatic HCC, Child-Pugh A liver function, and ECOG 0–1 receive rilvegostomig plus bevacizumab, with or without tremelimumab, or atezolizumab plus bevacizumab. Rilvegostomig is an investigational bispecific antibody targeting PD-1 and TIGIT.
ClinicalTrials.gov ID: NCT06921785
TrialFetch AI summary: This trial enrolls adults with previously untreated, PD-L1-high metastatic NSCLC without actionable drivers for approved first-line targeted therapy and with ECOG performance status 0–1. It compares first-line rilvegostomig, an investigational bispecific antibody targeting PD-1 and TIGIT, with pembrolizumab monotherapy.
ClinicalTrials.gov ID: NCT06868277
TrialFetch AI summary: Adults with HER2 IHC 2+/3+, pMMR, primary advanced or first recurrent endometrial carcinoma and no prior first-line systemic therapy are randomized to trastuzumab deruxtecan plus rilvegostomig or pembrolizumab, versus carboplatin/paclitaxel plus pembrolizumab. Trastuzumab deruxtecan is a HER2-directed antibody–drug conjugate delivering a topoisomerase I inhibitor; rilvegostomig is an investigational PD-1/TIGIT bispecific antibody.
ClinicalTrials.gov ID: NCT06989112
TrialFetch AI summary: This trial enrolls adults with previously untreated, unresectable locally advanced or metastatic HER2-positive, PD-L1–positive gastric or GEJ adenocarcinoma. It compares rilvegostomig, an investigational PD-1/TIGIT bispecific antibody, plus HER2-directed trastuzumab deruxtecan and a fluoropyrimidine against pembrolizumab, trastuzumab, and chemotherapy; a third arm receives rilvegostomig, trastuzumab, and chemotherapy.
ClinicalTrials.gov ID: NCT06764875
TrialFetch AI summary: For patients with untreated metastatic non-squamous NSCLC, PD-L1 expression ≥1%, and no actionable driver with an approved first-line targeted therapy, this trial compares rilvegostomig plus platinum–pemetrexed chemotherapy with pembrolizumab plus the same chemotherapy. Rilvegostomig is an investigational bispecific antibody targeting PD-1 and TIGIT; both groups continue their assigned immunotherapy with pemetrexed maintenance.
ClinicalTrials.gov ID: NCT06627647
TrialFetch AI summary: For patients with previously untreated, PD-L1–positive (≥1%) metastatic squamous NSCLC without an actionable driver alteration, this trial compares rilvegostomig, an investigational PD-1/TIGIT bispecific antibody, with pembrolizumab. Both are given with carboplatin plus paclitaxel or nab-paclitaxel, followed by the assigned immunotherapy alone.
ClinicalTrials.gov ID: NCT06692738
TrialFetch AI summary: Adults with previously untreated, unresectable stage IIIB/IIIC or metastatic non-squamous NSCLC, PD-L1 expression ≥50%, no actionable genomic alteration, and ECOG 0–1 are randomized to datopotamab deruxtecan plus rilvegostomig, rilvegostomig alone, or pembrolizumab alone. Datopotamab deruxtecan is a TROP2-directed antibody–drug conjugate carrying a topoisomerase I inhibitor; rilvegostomig is a bispecific PD-1/TIGIT antibody.
ClinicalTrials.gov ID: NCT06357533
TrialFetch AI summary: Adults with locally advanced or metastatic hepatocellular carcinoma receive the investigational PD-1/CTLA-4 bispecific antibody volrustomig alone or in combinations with bevacizumab, lenvatinib, or the investigational PD-1/TIGIT bispecific antibody rilvegostomig; a separate cohort receives rilvegostomig plus bevacizumab. Adults with previously untreated advanced or metastatic biliary tract cancer receive either bispecific antibody with gemcitabine and cisplatin.
ClinicalTrials.gov ID: NCT05775159
TrialFetch AI summary: Adults with previously untreated, HER2-negative, unresectable locally advanced or metastatic gastric or GEJ adenocarcinoma receive first-line combinations of chemotherapy with volrustomig (PD-1/CTLA-4), rilvegostomig (PD-1/TIGIT), or AZD7789 (PD-1/TIM-3), all investigational bispecific antibodies. Selected substudies instead pair one of these antibodies with the CLDN18.2-directed antibody–drug conjugate AZD0901 and fluoropyrimidine chemotherapy; these substudies require central CLDN18.2 testing.
ClinicalTrials.gov ID: NCT05702229
TrialFetch AI summary: Adults with advanced or metastatic endometrial, gastric, castration-resistant prostate, ovarian, colorectal, urothelial, or biliary tract cancer receive datopotamab deruxtecan, a TROP2-directed antibody–drug conjugate delivering a topoisomerase I inhibitor, either alone or in tumor-specific combinations. Combination partners include fluoropyrimidines, platinum chemotherapy, bevacizumab, corticosteroids, or the investigational bispecific antibodies volrustomig (PD-1/CTLA-4) and rilvegostomig (PD-1/TIGIT).
ClinicalTrials.gov ID: NCT05489211
TrialFetch AI summary: This study enrolls patients with HER2-overexpressing, unresectable locally advanced or metastatic non-squamous NSCLC and ECOG performance status 0–1; current cohorts require no prior systemic therapy for advanced disease and exclude tumors with actionable drivers that have approved treatments. Patients receive trastuzumab deruxtecan, a HER2-directed antibody–drug conjugate delivering a topoisomerase I inhibitor, with either volrustomig (PD-1/CTLA-4 bispecific) or rilvegostomig (PD-1/TIGIT bispecific), with or without carboplatin.
ClinicalTrials.gov ID: NCT04686305
TrialFetch AI summary: Adults with unresectable locally advanced or metastatic gastric, GEJ, or esophageal adenocarcinoma are eligible after progression on trastuzumab if HER2-positive, or in the first-line setting if HER2-positive or HER2-low, depending on the arm. Treatment includes trastuzumab deruxtecan, a HER2-directed antibody–drug conjugate delivering a topoisomerase I inhibitor, alone or with chemotherapy and/or checkpoint inhibitors, including the investigational PD-1/CTLA-4 bispecific volrustomig or PD-1/TIGIT bispecific rilvegostomig; one arm uses trastuzumab-based chemotherapy as a comparator.
ClinicalTrials.gov ID: NCT04379596
