NCT05382442Active, not recruitingPhase 2
A Study of AK112 With or Without AK117 in Metastatic Colorectal Cancer
A Phase II Study of AK112 With or Without AK117 for Patients With Metastatic Colorectal Cancer
Source: ClinicalTrials.gov · Last updated 14 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 254 (estimated)
- First submitted
- 16 May 2022
- Start date
- 27 Jun 2022
- Primary completion date
- 15 May 2026
- Lead sponsor
- Akeso
- Diseases
- Colorectal cancer
- NCT number
- NCT05382442
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 254
- From 27 Jun 2022 to the primary completion date, 15 May 2026
- 4 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with immunotherapy, including immune checkpoint inhibitors , immune checkpoint agonists, immune cell therapy and any treatment targeting tumor immune pathway
- Prior allogeneic stem cell or solid organ transplantation
- Receipt of a live, attenuated vaccine within 30 days prior to randomization, during treatment
Other illness
- History of autoimmune disease
- Positive test for human immunodeficiency virus,Active hepatitis B or hepatitis C
Other
- Known MSI-H(Microsatellite-Instability-High) or dMMR(Mismatch Repair-Deficient)
- Pregnancy or lactation
- Dysphagia
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Sixth Hospital,Sun Yat-sen University Coordinator of this site? Confirm its status | Guanzhou | China | Unknown status |
| - Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Murrieta | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.