- |||||||||| Yutuo (zimberelimab) / Arcus Biosci, Gilead, etrumadenant (AB928) / Arcus Biosci, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead
Enrollment closed, Trial completion date, Trial primary completion date, Combination therapy, Monotherapy: ARC-7: Study to Evaluate Monotherapy and Combination Immunotherapies in Participants With PD-L1 Positive Non-small Cell Lung Cancer (clinicaltrials.gov) - Nov 14, 2022 P2, N=150, Active, not recruiting, Recruiting --> Active, not recruiting | Trial completion date: Feb 2023 --> Feb 2024 | Trial primary completion date: Nov 2022 --> Feb 2024
- |||||||||| Yutuo (zimberelimab) / Arcus Biosci, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead
Enrollment open, Surgery, Metastases: 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) - Nov 3, 2022 P3, N=970, Recruiting, Recruiting --> Active, not recruiting | Trial completion date: Feb 2023 --> Feb 2024 | Trial primary completion date: Nov 2022 --> Feb 2024 Not yet recruiting --> Recruiting
- |||||||||| domvanalimab (AB154) / Arcus Biosci, Gilead
Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, Metastases: A Study to Evaluate the Safety and Tolerability of AB154 in Participants With Advanced Malignancies (clinicaltrials.gov) - Oct 18, 2022 P1, N=75, Active, not recruiting, Not yet recruiting --> Recruiting Trial completion date: Oct 2022 --> Feb 2023 | Trial primary completion date: Oct 2022 --> Feb 2023
- |||||||||| Yutuo (zimberelimab) / Arcus Biosci, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead
New P3 trial, Surgery, Metastases: 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) - Oct 5, 2022 P3, N=970, Not yet recruiting,
- |||||||||| Yutuo (zimberelimab) / Arcus Biosci, Gilead, etrumadenant (AB928) / Arcus Biosci, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead
Trial completion date, Trial primary completion date, Combination therapy: 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) - Aug 9, 2022 P2, N=30, Recruiting, N=321 --> 643 Trial completion date: Feb 2028 --> Feb 2029 | Trial primary completion date: Nov 2023 --> Nov 2024
- |||||||||| Yutuo (zimberelimab) / Arcus Biosci, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead, quemliclustat (AB680) / Arcus Biosci, Gilead
Enrollment open, Combination therapy, IO biomarker, Metastases: 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) - Jul 27, 2022 P2, N=120, Recruiting, Enrolment is ongoing. Not yet recruiting --> Recruiting
- |||||||||| Yutuo (zimberelimab) / Arcus Biosci, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead, sotigalimab (PYX-107) / Pyxis Oncology
New P1/2 trial, Metastases: Switch Maintenance in Pancreatic (clinicaltrials.gov) - Jun 15, 2022 P1/2, N=46, Not yet recruiting,
- |||||||||| Yutuo (zimberelimab) / Arcus Biosci, Gilead, etrumadenant (AB928) / Arcus Biosci, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead
Trial completion date, Trial primary completion date, Combination therapy, Monotherapy: ARC-7: Study to Evaluate Monotherapy and Combination Immunotherapies in Participants With PD-L1 Positive Non-small Cell Lung Cancer (clinicaltrials.gov) - Apr 15, 2022 P2, N=150, Recruiting, Not yet recruiting --> Recruiting Trial completion date: Jun 2022 --> Feb 2023 | Trial primary completion date: Mar 2022 --> Nov 2022
- |||||||||| Yutuo (zimberelimab) / Arcus Biosci, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead, quemliclustat (AB680) / Arcus Biosci, Gilead
New P2 trial, Combination therapy, IO biomarker, Metastases: 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) - Apr 14, 2022 P2, N=120, Not yet recruiting,
- |||||||||| domvanalimab (AB154) / Arcus Biosci, Gilead
Enrollment closed, Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, Metastases: A Study to Evaluate the Safety and Tolerability of AB154 in Participants With Advanced Malignancies (clinicaltrials.gov) - Apr 11, 2022 P1, N=75, Active, not recruiting, Trial completion date: Jun 2022 --> Feb 2023 | Trial primary completion date: Mar 2022 --> Nov 2022 Recruiting --> Active, not recruiting | Trial completion date: May 2022 --> Oct 2022 | Trial primary completion date: May 2022 --> Oct 2022
- |||||||||| AB308 / Arcus Biosci, Gilead, Otsuka
Anti-TIGIT antibodies promote immune activation relevant to targeting stem-like and tumor-specific T cells in combination with anti-PD-1 (Exhibit Hall; P950) - Apr 8, 2022 - Abstract #IMMUNOLOGY2022IMMUNOLOGY_1910; In mice, while combining Fc-silent or Fc-enabled anti-mouse TIGIT antibody with anti-PD-1 resulted in greater tumor growth inhibition than with anti-PD-1 alone, the activity of Fc-enabled anti-TIGIT was associated with intratumoral Treg depletion. These data provide a rationale for combination with immune-activating agents and support ongoing clinical evaluation of AB154 and AB308 with biomarker strategies focused on understanding the role of Fc functionality.
- |||||||||| Trodelvy (sacituzumab govitecan-hziy) / Gilead
Trial completion date, Trial primary completion date, Metastases: TROPHY-U-01: Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread (clinicaltrials.gov) - Apr 6, 2022 P2, N=321, Recruiting, These data provide a rationale for combination with immune-activating agents and support ongoing clinical evaluation of AB154 and AB308 with biomarker strategies focused on understanding the role of Fc functionality. Trial completion date: Oct 2024 --> Jun 2025 | Trial primary completion date: Oct 2022 --> Jun 2023
- |||||||||| zimberelimab (AB122) / Arcus Biosci, Otsuka, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead
[VIRTUAL] ARC - 10: Phase 3 Study of Zimberelimab ± Domvanalimab vs Standard Chemotherapy in Front - Line, PD - L1 - High, Metastatic NSCLC (ePoster Hall) - Aug 19, 2021 - Abstract #IASLCWCLC2021IASLC_WCLC_1307; P3 Arm A patients may crossover to Arm B upon documented PD; however, no crossover is allowed from Arm B to Arm C. For Arm A vs Arm B, the primary endpoint is overall survival (OS) and for Arm B vs Arm C, the co-primary endpoints are investigator-assessed PFS and OS; additional endpoints include quality of life assessments and safety. Study recruitment is planned in Asia, Latin America, Africa, and Eastern Europe.
- |||||||||| domvanalimab (AB154) / Arcus Biosci, Gilead
Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, Metastases: A Study to Evaluate the Safety and Tolerability of AB154 in Participants With Advanced Malignancies (clinicaltrials.gov) - Aug 18, 2021 P1, N=74, Recruiting, Study recruitment is planned in Asia, Latin America, Africa, and Eastern Europe. Trial completion date: Nov 2021 --> May 2022 | Trial primary completion date: Jul 2021 --> Jan 2022
- |||||||||| Yutuo (zimberelimab) / Arcus Biosci, Gilead, etrumadenant (AB928) / Arcus Biosci, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead
Enrollment open, Combination therapy: 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) - Aug 11, 2021 P2, N=30, Recruiting, Trial completion date: Nov 2021 --> May 2022 | Trial primary completion date: Jul 2021 --> Jan 2022 Not yet recruiting --> Recruiting
- |||||||||| Yutuo (zimberelimab) / Arcus Biosci, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead
Enrollment open, Combination therapy: AB154 Combined With AB122 for Recurrent Glioblastoma (clinicaltrials.gov) - May 2, 2021 P1, N=46, Recruiting, Trial completion date: Aug 2023 --> Oct 2024 | Trial primary completion date: Jun 2023 --> Oct 2022 Not yet recruiting --> Recruiting
- |||||||||| Yutuo (zimberelimab) / Arcus Biosci, Gilead, etrumadenant (AB928) / Arcus Biosci, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead
New P2 trial, Combination therapy: 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) - Mar 9, 2021 P2, N=30, Not yet recruiting,
- |||||||||| zimberelimab (AB122) / Arcus Biosci, Otsuka, Gilead, AB928 / Arcus Biosci, Otsuka, domvanalimab (AB154) / Arcus Biosci, Gilead
[VIRTUAL] ARC-7: A phase II study to evaluate the safety and efficacy of zimberelimab alone, AB154 in combination with zimberelimab, and AB154 in combination with zimberelimab and AB928 in front-line, PD-L1 expressing, non-small cell lung cancer (NSCLC) (On-Demand) - Jul 24, 2020 - Abstract #ESMO2020ESMO_2199; P2 Funding: Arcus Biosciences. Clinical trial identification: NCT04262856.
- |||||||||| Yutuo (zimberelimab) / Arcus Biosci, Gilead, etrumadenant (AB928) / Arcus Biosci, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead
Trial initiation date, Combination therapy, Monotherapy: ARC-7: Study to Evaluate Monotherapy and Combination Immunotherapies in Participants With PD-L1 Positive Non-small Cell Lung Cancer (clinicaltrials.gov) - Jun 17, 2020 P2, N=150, Recruiting, Trial completion date: Dec 2020 --> Nov 2021 | Trial primary completion date: Jul 2020 --> Jul 2021 Initiation date: Jan 2020 --> May 2020
- |||||||||| Combination of anti-TIGIT and anti-PD-1 antibodies enhance antitumor response in a PD-1/TIGIT double HuGEMM™ model engrafted with mouse syngeneic tumors (Virtual Meeting II: E-Posters) - May 16, 2020 - Abstract #AACRII2020AACR-II_817;
TIGIT on CD8+ T cells can inhibit adjacent CD226 co-stimulatory signaling by binding to PVR at a higher affinity or disrupting the homodimerization of CD226.Therefore, various therapeutic monoclonal antibodies against TIGIT have been developed and are now undergoing clinical testing, for example, tiragolumab (Phase II), BMS-986207 (Phase II), AB-154 (Phase I), MK-7684 (Phase I), etc. However, we are still lacking suitable preclinical models for the efficacy assessment and PK/PD evaluation of human TIGIT antibodies...We also used Balb/c Background PD-1/TIGIT dKI HuGEMM mice to test the antitumor effects of tiragolumab monotherapy and its combination with the anti-PD1 antibody Keytruda®, where CT26.WT syngeneic tumors were treated... Our TIGIT KI HuGEMM and PD-1/TIGIT dKI HuGEMM provide powerful preclinical models to assess the efficacy of human TIGIT antibodies and their combination with human anti-PD-1 or other immune modulators.
- |||||||||| Baize’an (tislelizumab) / BeiGene, BMS, AB154 / Arcus Biosci, BGB-A1217 / BeiGene
Profiling exhausted T cells using Vectra® Polaris™multiplex immunofluorescence assay in HNSCC (Virtual Meeting II: E-Posters) - May 16, 2020 - Abstract #AACRII2020AACR-II_3750; Currently AB154, a fully humanized immunoglobulin G1 monoclonal antibody targeting human TIGIT is in phase I clinical trials in HNSCC patients and BGB-A1217, an anti-TIGIT monoclonal antibody in combination with anti-PD-1 monoclonal antibody Tislelizumab is in a Phase 1/1b clinical trial in patients with advanced solid tumors. The Vectra Polaris imaging reported in this study identifies T cell composition in the tumor microenvironment of patients facing high mortality.
- |||||||||| Yutuo (zimberelimab) / Arcus Biosci, Gilead, etrumadenant (AB928) / Arcus Biosci, Gilead, domvanalimab (AB154) / Arcus Biosci, Gilead
New P2 trial, Combination therapy, Monotherapy: ARC-7: Study to Evaluate Monotherapy and Combination Immunotherapies in Participants With PD-L1 Positive Non-small Cell Lung Cancer (clinicaltrials.gov) - Feb 9, 2020 P2, N=150, Recruiting,
- |||||||||| domvanalimab (AB154) / Arcus Biosci, Gilead
Enrollment change, Combination therapy, Monotherapy, Metastases: A Study to Evaluate the Safety and Tolerability of AB154 in Participants With Advanced Malignancies (clinicaltrials.gov) - Apr 16, 2019 P1, N=242, Recruiting, The data presented here provide: 1) rationale for clinical development of a non-depleting a-TIGIT blocking antibody (AB154), 2) evidence of AB154-related immune activation in subjects with advanced solid tumors, 3) evidence supporting AB154 as a rational combination partner with a-PD-1 (AB122). N=42 --> 242
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