QUEMLICLUSTAT for Upper gastrointestinal tract cancer | Advanced upper gastrointestinal tract malignancies | Gastrointestinal tract malignancies

Inclusion criteria

• {"criterion_text":"- Participants with histologically confirmed diagnosis of locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma with life expectancy ≥3 months as assessed by the Investigator"}
• {"criterion_text":"- Eastern cooperative oncology group (ECOG) Performance Score of 0-1"}
• {"criterion_text":"- At least one measurable target lesion per RECIST v1.1."}
• {"criterion_text":"- Adequate organ and marrow function"}
• {"criterion_text":"- Able to provide an archival tumor sample that is representative of the cancer under investigation and suitable for central PD-L1 testing"}

Exclusion criteria

• {"criterion_text":"- Participants with underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of investigational products hazardous"}
• {"criterion_text":"- Only for Cohort A: Known Human Epidermal Growth Factor Receptor 2 (HER-2) positive tumor"}
• {"criterion_text":"- Known untreated, symptomatic, or actively progressing central nervous system (brain) metastases. Participants with leptomeningeal metastases are excluded from enrollment."}
• {"criterion_text":"- Discontinued use of prior immune checkpoint therapy due to immune related adverse events; received prior treatment with an anti-TIGIT monoclonal antibody."}
• {"criterion_text":"- History of trauma or major surgery within 28 days prior to enrollment."}

Primary endpoints

• {"endpoint_text":"- The Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and any Clinically meaningful trends in safety parameters [Time Frame: Up to 18 months]","definition_or_measurement_approach":"Incidence and severity of AEs/SAEs and clinically meaningful trends in safety parameters assessed up to 18 months (safety monitoring per investigator/sponsor-defined procedures)."}
• {"endpoint_text":"- Objective Response Rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and assessed by the investigator [Time Frame: Up to 18 months]","definition_or_measurement_approach":"ORR measured per RECIST v1.1 and assessed by the investigator, time frame up to 18 months."}

Secondary endpoints

• {"endpoint_text":"- Objective Response Rate (ORR) as measured by PD-L1 Expression Level [Time Frame: Up to 18 months]","definition_or_measurement_approach":"ORR stratified/assessed according to PD-L1 expression level; time frame up to 18 months."}
• {"endpoint_text":"- Overall survival (OS) [Time Frame: From date of first dose until the date of death due to any cause (approximately 18 months)]","definition_or_measurement_approach":"OS measured from first dose until death from any cause (approximately 18 months)."}
• {"endpoint_text":"- Progression-free survival (PFS) as determined by the Investigator according to RECIST v1.1 [Time Frame: Up to 18 months]","definition_or_measurement_approach":"PFS determined by investigator per RECIST v1.1; time frame up to 18 months."}
• {"endpoint_text":"- Disease Control (complete response, partial response, or stable disease) for greater than equal to 12 weeks [Time Frame: Up to 18 months]","definition_or_measurement_approach":"Disease control defined as CR, PR, or SD for ≥12 weeks; assessed up to 18 months."}
• {"endpoint_text":"- Duration of response (DOR) as determined by the Investigator according to RECIST v1.1 [Time Frame: Up to 18 months]","definition_or_measurement_approach":"DOR per RECIST v1.1 assessed by investigator; time frame up to 18 months."}
• {"endpoint_text":"- Plasma concentration of domvanalimab [Time Frame: Up to 18 months]","definition_or_measurement_approach":"Pharmacokinetic plasma concentration measurements of domvanalimab up to 18 months."}
• {"endpoint_text":"- Plasma concentration of zimberelimab [Time Frame: Up to 18 months]","definition_or_measurement_approach":"Pharmacokinetic plasma concentration measurements of zimberelimab up to 18 months."}
• {"endpoint_text":"- Plasma concentration of quemliclustat [Time Frame: Up to 18 months]","definition_or_measurement_approach":"Pharmacokinetic plasma concentration measurements of quemliclustat up to 18 months."}
• {"endpoint_text":"- Percentage of participants with anti-drug antibodies to domvanalimab [Time Frame: Up to 18 months]","definition_or_measurement_approach":"Immunogenicity: percentage with anti-drug antibodies to domvanalimab up to 18 months."}
• {"endpoint_text":"- Percentage of participants with anti-drug antibodies to zimberelimab [Time Frame: Up to 18 months]","definition_or_measurement_approach":"Immunogenicity: percentage with anti-drug antibodies to zimberelimab up to 18 months."}

France

Earliest CTIS Part Ii Submission Date

02-10-2024

Latest Decision Or Authorization Date

25-11-2025

Processing Time Days

419

Number Of Sites

12

Number Of Participants

60

Primary sponsor

Full Name

Arcus Biosciences Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Clario

Responsibilities

Listed as third party (contact email: david.Horsley@clario.com) - sponsorDuties code 4

Name

Icon Clinical Research Limited

Responsibilities

Listed as third party (contact email: Erik.brooks@iconplc.com) - sponsorDuties code 4

Name

Icon Laboratory Services Inc.

Responsibilities

Listed as third party (contact email: Erik.brooks@iconplc.com) - sponsorDuties code 4

Third parties

• {"country":"Switzerland","full_name":"Clario","duties_or_roles":"sponsorDuties code 4","organisation_type":"Health care"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties code 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"sponsorDuties code 4","organisation_type":"Laboratory/Research/Testing facility"}