^
Contact us  to learn more about
our Premium Content:  News alerts, weekly reports and conference planners
DRUG:

Yutuo (zimberelimab)

i
Other names: AB122, WBP3055, GLS 010, GLS-010 , AB-122, WBP-3055
Company:
Arcus Biosci, Gilead, Gloria Pharma, Ligand, Otsuka, WuXi AppTec
Drug class:
PD1 inhibitor
Related drugs:
23h
Trial primary completion date • Checkpoint inhibition • Metastases
|
Yutuo (zimberelimab) • etrumadenant (AB928) • quemliclustat (AB680)
2d
Zimberelimab (AB122) With TIGIT Inhibitor Domvanalimab (AB154) in PD-1 Relapsed/Refractory Melanoma (clinicaltrials.gov)
P2, N=26, Recruiting, Diwakar Davar | Trial completion date: Jan 2028 --> Jan 2030 | Trial primary completion date: Jan 2025 --> Jan 2027
Trial completion date • Trial primary completion date
|
BRAF (B-raf proto-oncogene) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
|
BRAF mutation
|
Yutuo (zimberelimab) • domvanalimab (AB154)
26d
AB154 Combined With AB122 for Recurrent Glioblastoma (clinicaltrials.gov)
P1, N=46, Recruiting, Yale University | Trial completion date: Dec 2025 --> Feb 2025
Trial completion date • Combination therapy
|
Yutuo (zimberelimab) • domvanalimab (AB154)
29d
Enrollment closed • Combination therapy
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
PD-L1 IHC 22C3 pharmDx
|
Yutuo (zimberelimab) • domvanalimab (AB154) • etrumadenant (AB928)
30d
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=720, Recruiting, Gilead Sciences | Trial completion date: Dec 2027 --> Sep 2027 | Trial primary completion date: Dec 2027 --> Sep 2027
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
EGFR (Epidermal growth factor receptor) • 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)
30d
ARC-8: A Study to Evaluate the Safety and Tolerability of AB680 in Participants With Gastrointestinal Malignancies (clinicaltrials.gov)
P1, N=165, Active, not recruiting, Arcus Biosciences, Inc. | Trial completion date: Jun 2024 --> May 2027 | Trial primary completion date: Jun 2024 --> May 2027
Trial completion date • Trial primary completion date • Combination therapy
|
CD73 (5'-Nucleotidase Ecto)
|
gemcitabine • albumin-bound paclitaxel • Yutuo (zimberelimab) • quemliclustat (AB680)
1m
Study of GS-1811 Given Alone or With Zimberelimab in Adults With Advanced Solid Tumors (clinicaltrials.gov)
P1, N=376, Recruiting, Gilead Sciences | N=216 --> 376 | Trial completion date: Feb 2027 --> Dec 2027 | Trial primary completion date: Jun 2026 --> Dec 2027
Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
Yutuo (zimberelimab) • GS-1811
1m
EDGE-Gastric: A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants With Advanced Upper Gastrointestinal Tract Malignancies (clinicaltrials.gov)
P2, N=360, Recruiting, Arcus Biosciences, Inc. | N=200 --> 360 | Trial completion date: Nov 2025 --> Jun 2027 | Trial primary completion date: Sep 2025 --> Sep 2026
Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
PD-L1 (Programmed death ligand 1)
|
5-fluorouracil • oxaliplatin • Yutuo (zimberelimab) • leucovorin calcium • domvanalimab (AB154) • quemliclustat (AB680)
1m
VELOCITY-Lung: Study of Novel Treatment Combinations in Patients With Lung Cancer (clinicaltrials.gov)
P2, N=397, Recruiting, Gilead Sciences | Trial completion date: Jan 2028 --> Jan 2027
Trial 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
Enrollment change • Enrollment closed • Metastases
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression • PD-L1 overexpression
|
VENTANA PD-L1 (SP263) Assay
|
Keytruda (pembrolizumab) • carboplatin • paclitaxel • pemetrexed • Yutuo (zimberelimab) • domvanalimab (AB154)
2ms
Study to Evaluate Safety and Clinical Activity of AB122 in Biomarker Selected Participants With Advanced Solid Tumors (clinicaltrials.gov)
P1, N=18, Active, not recruiting, Arcus Biosciences, Inc. | Phase classification: P1b --> P1
Phase classification • IO biomarker • Metastases
|
TMB (Tumor Mutational Burden)
|
TMB-H
|
Yutuo (zimberelimab)
2ms
ELEVATE HNSCC: Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
P2, N=230, Active, not recruiting, Gilead Sciences | Recruiting --> Active, not recruiting
Enrollment closed • Combination therapy
|
PD-L1 (Programmed death ligand 1)
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • docetaxel • 5-fluorouracil • Yutuo (zimberelimab) • magrolimab (GS-4721)
2ms
AIRPanc: Combination Therapy in Patients With Localized Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov)
P2, N=60, Recruiting, Gulam Manji | Initiation date: Oct 2023 --> Jun 2024
Trial initiation date • Combination therapy • Checkpoint inhibition • Checkpoint block • Metastases
|
5-fluorouracil • oxaliplatin • irinotecan • Yutuo (zimberelimab) • leucovorin calcium • etrumadenant (AB928) • quemliclustat (AB680)
2ms
A Study to Evaluate the Safety and Tolerability of AB154 in Participants With Advanced Malignancies (clinicaltrials.gov)
P1, N=75, Active, not recruiting, Arcus Biosciences, Inc. | Trial completion date: Feb 2024 --> Nov 2024 | Trial primary completion date: Feb 2024 --> Nov 2024
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
Yutuo (zimberelimab) • domvanalimab (AB154)
3ms
AB122 Platform Study (clinicaltrials.gov)
P1, N=715, Recruiting, Taiho Pharmaceutical Co., Ltd. | N=367 --> 715 | Trial completion date: May 2024 --> May 2026 | Trial primary completion date: May 2024 --> May 2026
Enrollment change • Trial completion date • Trial primary completion date • Metastases
|
KRAS (KRAS proto-oncogene GTPase) • NRAS (Neuroblastoma RAS viral oncogene homolog)
|
KRAS mutation • NRAS mutation • KRAS wild-type • RAS wild-type • NRAS wild-type • KRAS exon 2 mutation
|
Avastin (bevacizumab) • Cyramza (ramucirumab) • Lytgobi (futibatinib) • Yutuo (zimberelimab) • Lonsurf (trifluridine/tipiracil) • Jeselhy (pimitespib) • pamufetinib (TAS-115)
3ms
Trial suspension • Combination therapy • Metastases
|
oxaliplatin • irinotecan • Yutuo (zimberelimab) • leucovorin calcium • fluorouracil topical • quemliclustat (AB680)
3ms
A Study to Evaluate AB308 in Combination With AB122 in Participants With Advanced Malignancies (clinicaltrials.gov)
P1, N=94, Active, not recruiting, Arcus Biosciences, Inc. | Trial completion date: Jan 2024 --> Mar 2025 | Trial primary completion date: Jan 2024 --> Mar 2025
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
Yutuo (zimberelimab) • ralzapastotug (AB308)
3ms
ARC-6: Adenosine Receptor Antagonist Combination Therapy for Metastatic Castrate Resistant Prostate Cancer (clinicaltrials.gov)
P1/2, N=173, Active, not recruiting, Arcus Biosciences, Inc. | Phase classification: P1b/2 --> P1/2 | Trial completion date: Apr 2024 --> Aug 2024 | Trial primary completion date: Apr 2024 --> Aug 2024
Phase classification • Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
docetaxel • Xtandi (enzalutamide capsule) • Yutuo (zimberelimab) • Trodelvy (sacituzumab govitecan-hziy) • etrumadenant (AB928) • quemliclustat (AB680)
3ms
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, Active, not recruiting, Arcus Biosciences, Inc. | Phase classification: P1b/2 --> P1/2 | Trial completion date: Jan 2024 --> Jul 2024 | Trial primary completion date: Jan 2024 --> Jul 2024
Phase classification • Trial completion date • Trial primary completion date • Metastases
|
Avastin (bevacizumab) • 5-fluorouracil • Stivarga (regorafenib) • Yutuo (zimberelimab) • leucovorin calcium • etrumadenant (AB928) • quemliclustat (AB680)
3ms
New P2 trial • Combination therapy • Mismatch repair
|
MSI (Microsatellite instability)
|
MSI-H/dMMR
|
Yutuo (zimberelimab) • domvanalimab (AB154)
3ms
STAR-121: A Phase III Randomized Study of Domvanalimab and Zimberelimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Untreated Metastatic Non-Small Cell Lung Cancer With No Actionable Gene Alterations. (PubMed, Clin Lung Cancer)
Enrollment in the STAR-121 study commenced on October 12, 2022, and is currently ongoing with completion planned by September 2024. The study completion is expected by December 2027.
P3 data • Journal • Combination therapy • PD(L)-1 Biomarker • IO biomarker • Metastases
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
|
PD-L1 expression • EGFR mutation • ALK mutation • EGFR mutation + ALK mutation
|
Keytruda (pembrolizumab) • Yutuo (zimberelimab) • domvanalimab (AB154)
3ms
New P1/2 trial
|
Yutuo (zimberelimab) • Trodelvy (sacituzumab govitecan-hziy)
4ms
ARC-27: A Study of AB801 Monotherapy and Combination Therapy in Participants With Advanced Malignancies (clinicaltrials.gov)
P1, N=80, Recruiting, Arcus Biosciences, Inc. | Not yet recruiting --> Recruiting
Enrollment open • Combination therapy • Metastases
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • STK11 (Serine/threonine kinase 11) • NTRK (Neurotrophic receptor tyrosine kinase)
|
EGFR mutation • STK11 mutation • ALK mutation
|
docetaxel • Yutuo (zimberelimab)
4ms
Enrollment open • Combination therapy • Metastases
|
Aidixi (disitamab vedotin) • Yutuo (zimberelimab)
4ms
Whether specific genetic feature predicted immunotherapy efficacy: A case report. (PubMed, Medicine (Baltimore))
PIK3CA-E542K, ErbB2 amplification, and SMAD4 mutations could be potential biomarkers for PD-1 inhibitors, but a single instance is insufficient to validate the hypotheses. A larger number of patients or more clinical data will be necessary to determine whether these gene mutations are appropriate biomarkers for patients when treatment with PD-1 inhibitors.
Journal • Tumor mutational burden • MSi-H Biomarker • PD(L)-1 Biomarker • IO biomarker
|
HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • SMAD4 (SMAD family member 4) • TYK2 (Tyrosine Kinase 2)
|
MSI-H/dMMR • HER-2 amplification • PIK3CA mutation • HER-2 mutation • PD-L1 negative • PIK3CA E545K • TMB-L • ALK mutation • PIK3CA E542K • SMAD4 mutation • PIK3CA E545 • PIK3CA E542
|
Yutuo (zimberelimab)
4ms
Domvanalimab and Zimberelimab in Advanced Liver Cancers (clinicaltrials.gov)
P2, N=58, Recruiting, University of Texas Southwestern Medical Center | Trial primary completion date: Jul 2025 --> Jul 2026
Trial primary completion date • Pan tumor • Metastases
|
Yutuo (zimberelimab) • domvanalimab (AB154)
4ms
Study of Gemcitabine, Cisplatin, AB680 and AB122 During First Line Treatment of Advanced Biliary Tract Cancers (clinicaltrials.gov)
P2, N=39, Recruiting, Nataliya Uboha | Trial completion date: Dec 2024 --> Jul 2025 | Trial primary completion date: Jun 2024 --> Jan 2025
Trial completion date • Trial primary completion date • Metastases
|
cisplatin • gemcitabine • Yutuo (zimberelimab) • quemliclustat (AB680)
4ms
Trial completion date • Trial primary completion date • Combination therapy
|
PD-L1 (Programmed death ligand 1)
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • docetaxel • 5-fluorouracil • Yutuo (zimberelimab) • magrolimab (GS-4721)
5ms
Enrollment open • Metastases
|
cisplatin • gemcitabine • Yutuo (zimberelimab) • quemliclustat (AB680)
5ms
Trial completion date • Trial primary completion date • Surgery • Metastases
|
Opdivo (nivolumab) • 5-fluorouracil • capecitabine • oxaliplatin • Yutuo (zimberelimab) • leucovorin calcium • domvanalimab (AB154)
5ms
New P2 trial
|
oxaliplatin • irinotecan • Yutuo (zimberelimab) • Teysuno (gimeracil/oteracil/tegafur)
5ms
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
Yutuo (zimberelimab)
5ms
ARC-8: Phase 1/1b randomized study of quemliclustat + gemcitabine/nab-paclitaxel ± zimberelimab in patients with treatment-naive metastatic pancreatic adenocarcinoma. (ASCO-GI 2024)
Results from ARC-8 demonstrate the addition of Q 100 mg ± Z to G/nP was safe and tolerable, with no significant added toxicity to GnP. Modulation of eADO with Q may confer benefit beyond radiographic measures of disease. The OS is promising and supports further development of Q in mPDAC.
Clinical • P1 data • PD(L)-1 Biomarker • IO biomarker • Metastases
|
CD73 (5'-Nucleotidase Ecto) • NT5E (5'-Nucleotidase Ecto)
|
CD73 elevation • CD73 expression
|
gemcitabine • albumin-bound paclitaxel • Yutuo (zimberelimab) • quemliclustat (AB680)
5ms
New P2 trial
|
PD-L1 (Programmed death ligand 1)
|
Focus V (anlotinib) • Halaven (eribulin mesylate) • Yutuo (zimberelimab)
5ms
Trial completion date • Trial primary completion date • Metastases
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • gemcitabine • Bavencio (avelumab) • Yutuo (zimberelimab) • Trodelvy (sacituzumab govitecan-hziy) • domvanalimab (AB154)
5ms
New P2 trial • Combination therapy • Metastases
|
Aidixi (disitamab vedotin) • Yutuo (zimberelimab)
6ms
Study of GS-9911 With or Without Antibody Treatment for Adults With Solid Tumors (clinicaltrials.gov)
P1, N=120, Recruiting, Gilead Sciences | Not yet recruiting --> Recruiting
Enrollment open • Combination therapy • Metastases
|
Yutuo (zimberelimab)
6ms
Adjuvant Chemoradiotherapy Followed by Zimberelimab for Locally Advanced Cervical Cancer. (clinicaltrials.gov)
P2, N=24, Not yet recruiting, Obstetrics & Gynecology Hospital of Fudan University
New P2 trial • Metastases
|
cisplatin • Yutuo (zimberelimab)
6ms
New P1 trial • Combination therapy • Metastases
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • STK11 (Serine/threonine kinase 11) • NTRK (Neurotrophic receptor tyrosine kinase)
|
EGFR mutation • STK11 mutation • ALK mutation
|
docetaxel • Yutuo (zimberelimab)
6ms
ARC-7: Study to Evaluate Monotherapy and Combination Immunotherapies in Participants With PD-L1 Positive Non-small Cell Lung Cancer (clinicaltrials.gov)
P2, N=151, Active, not recruiting, Arcus Biosciences, Inc. | Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Feb 2024 --> Feb 2025
Trial completion date • Trial primary completion date • Combination therapy
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression • PD-L1 overexpression
|
Yutuo (zimberelimab) • domvanalimab (AB154) • etrumadenant (AB928)
6ms
Enrollment change • Trial withdrawal • Combination therapy • IO biomarker • Metastases
|
cisplatin • Yutuo (zimberelimab) • etrumadenant (AB928)
7ms
ARC-8: A Study to Evaluate the Safety and Tolerability of AB680 in Participants With Gastrointestinal Malignancies (clinicaltrials.gov)
P1, N=165, Active, not recruiting, Arcus Biosciences, Inc. | Recruiting --> Active, not recruiting | Trial completion date: Jan 2024 --> Jun 2024 | Trial primary completion date: Jan 2024 --> Jun 2024
Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy
|
gemcitabine • albumin-bound paclitaxel • Yutuo (zimberelimab) • quemliclustat (AB680)