Evaluating AK112 with or without AK117 for metastatic colorectal cancer
A Phase II Study of AK112 With or Without AK117 for Patients With Metastatic Colorectal Cancer
This study is testing if a new drug called AK112, alone or with another drug called AK117, can help people with metastatic colorectal cancer who can’t have surgery, while they also receive standard chemotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 254 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Akeso Industry-sponsored |
| Drugs / interventions | bevacizumab, immunotherapy |
| Locations | 2 sites (Los Angeles, California and 1 other locations) |
| Trial ID | NCT05382442 on ClinicalTrials.gov |
What this trial studies
This Phase II trial aims to assess the efficacy, safety, and pharmacokinetics of AK112, both alone and in combination with AK117, in patients with metastatic colorectal cancer who are not candidates for surgery. Participants will be divided into two parts based on their previous treatment history, with specific eligibility criteria focusing on their cancer diagnosis and overall health status. The study will involve administering AK112 and AK117 alongside standard chemotherapy agents like Oxaliplatin, Capecitabine, and Irinotecan.
Who should consider this trial
Good fit: Ideal candidates include individuals with histologically confirmed colorectal adenocarcinoma who have not received prior systemic antitumor therapy or those who have previously received treatment but could not tolerate standard options.
Not a fit: Patients with known microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with metastatic colorectal cancer who have limited alternatives.
How similar studies have performed: Other studies have explored similar combinations in colorectal cancer, but the specific use of AK112 and AK117 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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
Where this trial is running
Los Angeles, California and 1 other locations
- Summit Therapeutics Research Site — Los Angeles, California, United States (Recruiting)
- The Sixth Hospital,Sun Yat-sen University — Guanzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Xufang Yu, MD
- Email: clincialtrails@akesobio.com
- Phone: +86(0760)89873999
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.