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

Arcus Biosciences, Inc.0 个研究点目标入组 360 人开始时间: 2022年3月23日最近更新: 2024年7月15日

试验速览

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•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

•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.

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