Active, not recruiting
Phase 2
A Study of AK112 With or Without AK117 in Metastatic Colorectal Cancer
Condition(s) studied
Metastatic Colorectal Cancer
Investigational drug(s) / intervention(s)
AK112AK117OxaliplatinCapecitabineIrinotecanLeucovorin5-fluorouracil
AK112: AK112 via intravenous (IV) infusion until disease progression or unacceptable toxicity
AK117: AK117 via intravenous (IV) infusion until disease progression or unacceptable toxicity
Oxaliplatin: Oxaliplatin via IV infusion
Capecitabine: Capecitabine via oral,The total daily dose was 2000mg/sqm, Each cycle was administered for 2 consecutive weeks, followed by a week of rest, with a treatment cycle every 21 days
Irinotecan: Irinotecan via IV infusion
Leucovorin: Leucovorin via IV infusion
5-fluorouracil: 5-fluorouracil via IV infusion
Study 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.
Eligibility
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
Primary outcome measure(s)
- Objective response rates (ORR) — Up to approximately 2 years
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1
- Number of participants with adverse events (AEs) — Up to approximately 2 years
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Trial sites (4)
| Facility | City | Region | Status |
|---|
| Summit Therapeutics Research Site |
Los Angeles |
California |
|
| Summit Therapeutics Research Site |
Murrieta |
California |
|
| Summit Therapeutics Research Site |
Fairfax |
Virginia |
|
| The Sixth Hospital,Sun Yat-sen University |
Guanzhou |
Guangdong |
|