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

Phase 1

• Conditions: Advanced Upper Gastrointestinal Tract Malignancies; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-006291-16-FR
• Lead Sponsor: Arcus Biosciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-23
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 360

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified