^
    2d
    STAR-121: Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=1021, Active, not recruiting, Gilead Sciences | Recruiting --> Active, not recruiting
    Enrollment closed • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • RET (Ret Proto-Oncogene) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    BRAF mutation • ALK mutation • RET mutation
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • albumin-bound paclitaxel • pemetrexed • Yutuo (zimberelimab) • domvanalimab (AB154)
    19d
    STAR-121: Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=1069, Recruiting, Gilead Sciences | Trial completion date: Jun 2028 --> Jan 2029
    Trial completion date • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • RET (Ret Proto-Oncogene) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    BRAF mutation • ALK mutation • RET mutation
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • albumin-bound paclitaxel • pemetrexed • Yutuo (zimberelimab) • domvanalimab (AB154)
    21d
    Trial of FOLFIRI + Zimberelimab + Domvanalimab vs FOLFIRI With a Hybrid Synthetic Control Arm in Second Line Treatment of Neuroendocrine Carcinoma of Gastro-enteropancreatic or Unknown Origin (REWENEC 01) (clinicaltrials.gov)
    P2, N=122, Not yet recruiting, Hospices Civils de Lyon
    New P2 trial
    |
    5-fluorouracil • irinotecan • Yutuo (zimberelimab) • leucovorin calcium • domvanalimab (AB154)
    27d
    AB154 Combined With AB122 for Recurrent Glioblastoma (clinicaltrials.gov)
    P1, N=46, Active, not recruiting, Yale University | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Nov 2025 --> Jul 2026
    Trial completion date • Trial primary completion date
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
    |
    Yutuo (zimberelimab) • domvanalimab (AB154)
    1m
    Zimberelimab + Domvanalimab in Gastroesophageal Adenocarcinoma (clinicaltrials.gov)
    P2, N=0, Withdrawn, Massachusetts General Hospital | Not yet recruiting --> Withdrawn
    Trial withdrawal
    |
    docetaxel • 5-fluorouracil • oxaliplatin • Yutuo (zimberelimab) • leucovorin calcium • domvanalimab (AB154)
    2ms
    Zimberelimab + Domvanalimab in Gastroesophageal Adenocarcinoma (clinicaltrials.gov)
    P2, N=28, Not yet recruiting, Massachusetts General Hospital
    New P2 trial
    |
    docetaxel • 5-fluorouracil • oxaliplatin • Yutuo (zimberelimab) • leucovorin calcium • domvanalimab (AB154)
    3ms
    Safety and Efficacy of Zimberelimab (AB122) in Combination With Domvanalimab (AB154) and Etrumadenant (AB928) in Patients With Previously Treated Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=30, Active, not recruiting, Washington University School of Medicine | Trial completion date: Dec 2029 --> Jun 2030 | Trial primary completion date: Oct 2025 --> Apr 2026
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Yutuo (zimberelimab) • domvanalimab (AB154) • etrumadenant (AB928)
    3ms
    STAR-221: A Clinical Trial of a New Combination Treatment, Domvanalimab and Zimberelimab, Plus Chemotherapy, for People With an Upper Gastrointestinal Tract Cancer That Cannot be Removed With Surgery That Has Spread to Other Parts of the Body (clinicaltrials.gov)
    P3, N=1040, Active, not recruiting, Arcus Biosciences, Inc. | Trial completion date: Feb 2027 --> Jun 2026 | Trial primary completion date: Dec 2026 --> Jun 2026
    Trial completion date • Trial primary completion date
    |
    Opdivo (nivolumab) • 5-fluorouracil • capecitabine • oxaliplatin • Yutuo (zimberelimab) • leucovorin calcium • domvanalimab (AB154)
    4ms
    Domvanalimab and zimberelimab in advanced gastric, gastroesophageal junction or esophageal cancer: a phase 2 trial. (PubMed, Nat Med)
    In arm A1, presented here, dual blockade of TIGIT and PD-1 with domvanalimab (Fc-silent anti-TIGIT) and zimberelimab (anti-PD-1) plus oxaliplatin, leucovorin, fluorouracil (FOLFOX) was evaluated in patients with previously untreated advanced HER2-negative gastric, gastroesophageal junction or esophageal adenocarcinoma. Dual TIGIT and PD-1 blockade with domvanalimab and zimberelimab plus chemotherapy demonstrated encouraging efficacy, and the regimen is being evaluated in the phase 3 STAR-221 trial. ClinicalTrials.gov identifier: NCT05329766 .
    P2 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
    |
    PD-L1 expression • HER-2 negative
    |
    5-fluorouracil • oxaliplatin • Yutuo (zimberelimab) • leucovorin calcium • domvanalimab (AB154)
    4ms
    VELOCITY-Lung: Study of Novel Treatment Combinations in Patients With Lung Cancer (clinicaltrials.gov)
    P2, N=593, Recruiting, Gilead Sciences | Trial completion date: Dec 2028 --> Sep 2029 | Trial primary completion date: Jan 2027 --> Sep 2029
    Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    Opdivo (nivolumab) • cisplatin • carboplatin • docetaxel • albumin-bound paclitaxel • pemetrexed • Yutuo (zimberelimab) • Trodelvy (sacituzumab govitecan-hziy) • domvanalimab (AB154) • etrumadenant (AB928)
    4ms
    IMMUNORARE5: A National Platform of 5 Academic Phase II Trials Coordinated by Lyon University Hospital to Assess the Safety and the Efficacy of the IMMUNOtherapy With Domvanalimab + Zimberelimab Combination in Patients With Advanced RARE Cancers (clinicaltrials.gov)
    P2, N=154, Recruiting, Hospices Civils de Lyon | Initiation date: May 2025 --> Oct 2025 | Not yet recruiting --> Recruiting
    Enrollment open • Trial initiation date
    |
    5-fluorouracil • oxaliplatin • Yutuo (zimberelimab) • leucovorin calcium • domvanalimab (AB154)
    4ms
    EDGE-Lung: Study With Various Immunotherapy Treatments in Participants With Lung Cancer (clinicaltrials.gov)
    P2, N=400, Active, not recruiting, Gilead Sciences | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    docetaxel • Yutuo (zimberelimab) • domvanalimab (AB154) • quemliclustat (AB680)