Status:
ACTIVE_NOT_RECRUITING
A Study of AK112 With or Without AK117 in Metastatic Colorectal Cancer
Lead Sponsor:
Akeso
Collaborating Sponsors:
Summit Therapeutics
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 12 2028
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT05382442
Start Date
June 27 2022
End Date
August 12 2028
Last Update
October 14 2025
Active Locations (4)
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1
Summit Therapeutics Research Site
Los Angeles, California, United States, 90067
2
Summit Therapeutics Research Site
Murrieta, California, United States, 92562
3
Summit Therapeutics Research Site
Fairfax, Virginia, United States, 22031
4
The Sixth Hospital,Sun Yat-sen University
Guanzhou, Guangdong, China, 510000