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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:
    14d
    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
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
    |
    Yutuo (zimberelimab) • Trodelvy (sacituzumab govitecan-hziy)
    29d
    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)
    1m
    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)
    2ms
    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
    |
    Avastin (bevacizumab) • 5-fluorouracil • Stivarga (regorafenib) • Yutuo (zimberelimab) • leucovorin calcium • etrumadenant (AB928) • quemliclustat (AB680)
    2ms
    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)
    2ms
    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)
    2ms
    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)
    2ms
    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)
    3ms
    A Phase 2 Study to Evaluate the Triplet Combination of Pemetrexed Plus AB928 (Etrumadenant) + AB122 (Zimberelimab) in Patients With Previously Treated Advanced or Metastatic MTAP Deficient Urothelial Carcinoma (clinicaltrials.gov)
    P2, N=20, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Sep 2025 --> Sep 2027 | Trial primary completion date: Sep 2025 --> Sep 2027
    Trial completion date • Trial primary completion date
    |
    MTAP (Methylthioadenosine Phosphorylase) • IL17A (Interleukin 17A)
    |
    pemetrexed • Yutuo (zimberelimab) • etrumadenant (AB928)
    3ms
    Study of GS-9911 With or Without Antibody Treatment for Adults With Solid Tumors (clinicaltrials.gov)
    P1, N=45, Active, not recruiting, Gilead Sciences | Recruiting --> Active, not recruiting | N=120 --> 45
    Enrollment closed • Enrollment change
    |
    Yutuo (zimberelimab)
    3ms
    ARC-25: Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers (clinicaltrials.gov)
    P1, N=40, Active, not recruiting, Arcus Biosciences, Inc. | Recruiting --> Active, not recruiting | N=87 --> 40
    Enrollment closed • Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    5-fluorouracil • oxaliplatin • Yutuo (zimberelimab) • leucovorin calcium • AB598
    3ms
    Study of GS-4528 in Adults With Solid Tumors (clinicaltrials.gov)
    P1, N=182, Active, not recruiting, Gilead Sciences | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Yutuo (zimberelimab) • GS-4528