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

Description

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.

Conditions

Metastatic Colorectal Cancer

Study Overview

Study Details

Study overview

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.

A Phase II Study of AK112 With or Without AK117 for Patients With Metastatic Colorectal Cancer

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

Condition
Metastatic Colorectal Cancer
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Valkyrie Clinical Trials, Los Angeles, California, United States, 90067

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Histologically proven diagnosis of colorectal adenocarcinoma
  • * Part1: Subjects who have not previously received any systemic antitumor therapy and who have previously received neoadjuvant or adjuvant therapy, the first detection of recurrence or metastasis should be ≥12 months after the last administration of neoadjuvant or adjuvant therapy
  • * Part2: Subjects who have previously received systemic therapy including fluorouracil, oxaliplatin, irinotecan, bevacizumab or anti-EGFR antibodies or could not tolerate or have contraindications to standard treatment
  • * Eastern Cooperative Oncology Group performance status of 0 or 1
  • * Measurable disease as defined by RECIST v1.1
  • * Adequate hematologic and organ function
  • * Known MSI-H(Microsatellite-Instability-High) or dMMR(Mismatch Repair-Deficient)
  • * Prior treatment with immunotherapy, including immune checkpoint inhibitors , immune checkpoint agonists, immune cell 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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Akeso,

Study Record Dates

2028-08-12