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DRUG:

Yutuo (zimberelimab)

i
Other names: AB122, WBP3055, GLS 010, GLS-010 , AB-122, WBP-3055, AB 122, GLS010, WBP 3055
Company:
Arcus Biosci, Gilead, Gloria Pharma, Ligand, Otsuka, WuXi AppTec
Drug class:
PD1 inhibitor
Related drugs:
5d
Trial completion date • IO biomarker
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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)
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BRAF mutation • ALK mutation • RET mutation
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Keytruda (pembrolizumab) • cisplatin • carboplatin • albumin-bound paclitaxel • pemetrexed • Yutuo (zimberelimab) • domvanalimab (AB154)
5d
Zimberelimab and Quemliclustat in Combination With Chemotherapy for the Treatment of Patients With Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma (clinicaltrials.gov)
P1/2, N=56, Recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Mar 2026 --> Mar 2027 | Trial primary completion date: Dec 2025 --> Dec 2026
Trial completion date • Trial primary completion date
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oxaliplatin • irinotecan • Yutuo (zimberelimab) • leucovorin calcium • fluorouracil topical • quemliclustat (AB680)
6d
New P2 trial
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5-fluorouracil • irinotecan • Yutuo (zimberelimab) • leucovorin calcium • domvanalimab (AB154)
11d
Spatiotemporal Immune Determinants of Response to Immune Rechallenge in Advanced Cervical Cancer. (PubMed, Cancer Discov)
Participants received a combined regimen of zimberelimab and lenvatinib (immune rechallenge). A population of CD45+CD3+Lyz+dyad cells, composed of T cells and myeloid cells, was correlated with clinical benefit. Our findings proved immune rechallenge could be an effective treatment for patients with advanced cervical cancer who progressed on or after prior ICIs therapy.
Journal
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PTPRC (Protein Tyrosine Phosphatase Receptor Type C)
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Lenvima (lenvatinib) • Yutuo (zimberelimab)
13d
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
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IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
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Yutuo (zimberelimab) • domvanalimab (AB154)
25d
Zimberelimab + Domvanalimab in Gastroesophageal Adenocarcinoma (clinicaltrials.gov)
P2, N=0, Withdrawn, Massachusetts General Hospital | Not yet recruiting --> Withdrawn
Trial withdrawal
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docetaxel • 5-fluorouracil • oxaliplatin • Yutuo (zimberelimab) • leucovorin calcium • domvanalimab (AB154)
1m
Zimberelimab + Domvanalimab in Gastroesophageal Adenocarcinoma (clinicaltrials.gov)
P2, N=28, Not yet recruiting, Massachusetts General Hospital
New P2 trial
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docetaxel • 5-fluorouracil • oxaliplatin • Yutuo (zimberelimab) • leucovorin calcium • domvanalimab (AB154)
2ms
Study design and rationale for the NeoTRACE trial: a multicenter phase II study of neoadjuvant sacituzumab govitecan plus zimberelimab followed by adjuvant zimberelimab with or without sacituzumab govitecan in patients with resectable non-small cell lung cancer. (PubMed, Future Oncol)
Previous studies showed ADC and immunotherapy combinations are effective in advanced NSCLC, suggesting potential perioperative benefit. This study aims to improve pCR rate, reduce toxicity, enhance surgical eligibility, and personalize adjuvant treatment to improve long-term outcomes.Clinical Trial Registration: EudraCT: 2024-517561-16.
P2 data • Journal • PD(L)-1 Biomarker • IO biomarker
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EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
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Yutuo (zimberelimab) • Trodelvy (sacituzumab govitecan-hziy)
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
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PD-L1 (Programmed death ligand 1)
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PD-L1 expression
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PD-L1 IHC 22C3 pharmDx
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Yutuo (zimberelimab) • domvanalimab (AB154) • etrumadenant (AB928)
3ms
Trial completion date • Trial primary completion date
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Opdivo (nivolumab) • 5-fluorouracil • capecitabine • oxaliplatin • Yutuo (zimberelimab) • leucovorin calcium • domvanalimab (AB154)
3ms
ARC-9: An Open Label Study Evaluating the Efficacy and Safety of Etrumadenant (AB928) Based Treatment Combinations in Participants With Metastatic Colorectal Cancer. (clinicaltrials.gov)
P1/2, N=227, Completed, Arcus Biosciences, Inc. | Active, not recruiting --> Completed | Trial completion date: Mar 2026 --> Sep 2025
Trial completion • Trial completion date
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Avastin (bevacizumab) • 5-fluorouracil • Stivarga (regorafenib) • Yutuo (zimberelimab) • leucovorin calcium • etrumadenant (AB928) • quemliclustat (AB680)
3ms
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
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HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
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PD-L1 expression • HER-2 negative
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5-fluorouracil • oxaliplatin • Yutuo (zimberelimab) • leucovorin calcium • domvanalimab (AB154)