A safety and efficacy study of treatment combinations with and without chemotherapy in adult patients with advanced upper gastrointestinal tract malignancies

A Phase 2 Trial to Evaluate the Safety and Efficacy of Combination Therapies in Patients with Advanced Upper Gastrointestinal Tract Malignancies (EDGE-Gastric)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-006291-16-FR

Enrollment

360

Registered

2022-03-23

Start date

2022-05-24

Completion date

Unknown

Last updated

2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Upper Gastrointestinal Tract Malignancies

Interventions

Product Name: Domvanalimab Product Code: AB154 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Domvanalimab CAS Number: 2368219-35-4 Current Sponsor code: AB154 Concentration unit: mg/

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 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 2. Eastern cooperative oncology group (ECOG) Performance Score of 0-1 3. At least one measurable target lesion per RECIST v1.1. 4. Adequate organ and marrow function 5. Able to provide an archival tumor sample that is representative of the cancer under investigation and suitable for central PD-L1 testing Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 360 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Participants with underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of investigational products hazardous 2. Only for Cohort A: Known Human Epidermal Growth Factor Receptor 2 (HER-2) positive tumor 3. Known untreated symptomatic, or actively progressing Central Nervous System (brain) metastases. 4. Discontinued use of prior immune checkpoint therapy due to immune related adverse events; received prior treatment with an anti-TIGIT monoclonal antibody. 5. History of trauma or major surgery within 28 days prior to enrollment. 6. Use of any live vaccines against infectious diseases within 28 days prior to enrollment.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the safety and tolerability of combination therapies in patients with locally advanced unresectable or metastatic gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma. To assess the clinical activity of combination therapies in patients with locally advanced unresectable or metastatic gastric, GEJ, and esophageal adenocarcinoma.;Secondary Objective: To assess the clinical activity of the study treatment in each cohort according to PD-L1 expression. To describe the pharmacokinetic (PK) profile of domvanalimab, zimberelimab, and quemliclustat in combinations with and without chemotherapy. To describe immunogenic responses to domvanalimab and zimberelimab in immunotherapy-based combinations.;Primary end point(s): The incidence and severity of adverse events (AEs), serious adverse events (SAEs), and any clinically meaningful trends in safety parameters. Objective response rate (ORR) is defined as the percentage of patients with measurable disease who have achieved a confirmed best overall response of complete response (CR) or partial response (PR) to study therapy as measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and assessed by the investigator.;Timepoint(s) of evaluation of this end point: Please refer to protocol	—

Measure

Time frame

Main Objective: To assess the safety and tolerability of combination therapies in patients with locally advanced unresectable or metastatic gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma. To assess the clinical activity of combination therapies in patients with locally advanced unresectable or metastatic gastric, GEJ, and esophageal adenocarcinoma.;Secondary Objective: To assess the clinical activity of the study treatment in each cohort according to PD-L1 expression. To describe the pharmacokinetic (PK) profile of domvanalimab, zimberelimab, and quemliclustat in combinations with and without chemotherapy. To describe immunogenic responses to domvanalimab and zimberelimab in immunotherapy-based combinations.;Primary end point(s): The incidence and severity of adverse events (AEs), serious adverse events (SAEs), and any clinically meaningful trends in safety parameters. Objective response rate (ORR) is defined as the percentage of patients with measurable disease who have achieved a confirmed best overall response of complete response (CR) or partial response (PR) to study therapy as measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and assessed by the investigator.;Timepoint(s) of evaluation of this end point: Please refer to protocol

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Secondary

Measure	Time frame
Secondary end point(s): ORR as defined above. Overall survival (OS) is length of time from date of first dose (nonrandomized patients) or date of randomization (randomized patients) until the date of death from any cause. Progression-free survival (PFS) is the time from date of first dose (nonrandomized patients) or date of randomization (randomized patients) until disease progression or death from any cause, whichever comes first as measured per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the investigator. Disease control rate (DCR) is measured by the percentage of patients with a best overall confirmed response of CR or PR at any time plus Stable Disease (SD) = 12 weeks from start of study intervention until disease progression or death due to any cause. Duration of response (DoR) is measured from the time of first response (CR or PR) as assessed by the investigator, per RECIST 1.1 until the date of first documented disease progression or death, whichever comes first. Plasma or serum concentration of domvanalimab, zimberelimab and quemliclustat and estimated PK parameters. Percentage of patients who are anti-drug antibody (ADA)-positive and ADA negative.;Timepoint(s) of evaluation of this end point: Please refer to protocol	—

Measure

Time frame

Secondary end point(s): ORR as defined above. Overall survival (OS) is length of time from date of first dose (nonrandomized patients) or date of randomization (randomized patients) until the date of death from any cause. Progression-free survival (PFS) is the time from date of first dose (nonrandomized patients) or date of randomization (randomized patients) until disease progression or death from any cause, whichever comes first as measured per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the investigator. Disease control rate (DCR) is measured by the percentage of patients with a best overall confirmed response of CR or PR at any time plus Stable Disease (SD) = 12 weeks from start of study intervention until disease progression or death due to any cause. Duration of response (DoR) is measured from the time of first response (CR or PR) as assessed by the investigator, per RECIST 1.1 until the date of first documented disease progression or death, whichever comes first. Plasma or serum concentration of domvanalimab, zimberelimab and quemliclustat and estimated PK parameters. Percentage of patients who are anti-drug antibody (ADA)-positive and ADA negative.;Timepoint(s) of evaluation of this end point: Please refer to protocol

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Countries

Canada, Chile, France, Korea, Republic of, Serbia, United States

Contacts

Public ContactAllan Sison, Medical Monitor

Arcus Biosciences, Inc.

asison@arcusbio.com+1281-529-5195

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026