A Study of AK112 With or Without AK117 in Metastatic Colorectal Cancer

• Status: Not yet recruiting
• Trial end date: 2025-01-07
• Target enrollment: 0
• Participant gender: All

Summary

This trial is a Phase II study. The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of AK112 with or without AK117 in participants with metastatic colorectal cancer who are not suitable for surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Akeso
• Treatments: Bevacizumab; Capecitabine; Fluorouracil; Irinotecan; Leucovorin; Oxaliplatin

Criteria

Inclusion Criteria:

• Histologically proven diagnosis of colorectal adenocarcinoma

• Part1: Initially unresectable metastatic colorectal cancer(metastasis detected at diagnosis) not previously systemic antitumor therapy for metastatic disease.

• Part2: Prior radiation therapy for lesions which were primary or metastatic from colorectal cancer.Patient must have received at least 2 prior line and no more than 4 prior lines of systemic anticancer therapy.

• Eastern Cooperative Oncology Group performance status of 0 or 1

• Measurable disease as defined by RECIST v1.1

• Adequate hematologic and end-organ function

Exclusion Criteria:

• Known MSI-H or dMMR

• Prior treatment with immunotherapy, including immunocheckpoint inhibitors (anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.), immunocheckpoint agonists (ICOS, CD40, CD137, GITR, OX40 antibody, etc.), immunocell therapy and any treatment targeting tumor immune pathway.

• History of autoimmune disease

• Prior allogeneic stem cell or solid organ transplantation

• Positive test for human immunodeficiency virus,Active hepatitis B or hepatitis C

• Receipt of a live, attenuated vaccine within 30 days prior to randomization, during treatment

• Pregnancy or lactation

• Dysphagia