AK104 in Locally Advanced MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer (NCT04556253) | Clinical Trial Compass
Active — Not RecruitingPhase 2
AK104 in Locally Advanced MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer
China47 participantsStarted 2024-02-28
Plain-language summary
This is a single-arm, multicenter phase II clinical study. The aim is to evaluate the safety, tolerability, and anti-tumor activities of AK104(a PD-1/CTLA-4 bispecific antibody) in MSI-H/dMMR locally advanced gastric adenocarcinoma and colorectal cancer during the perioperative period.Eligible patients will receive AK104 for three cycles before surgery and at most 6 months after surgery. The primary endpoint is the pathological complete response rate.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Written and signed informed consent.
* Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or
* The estimated life expectancy of ≥3 months.
* Confirmed MSI-H/dMMR status by the central laboratory.
* For cohort 1, histologically or cytologically documented locally advanced gastric carcinoma(cT3-T4a, Nx, M0). For cohort 2, histologically or cytologically documented locally advanced colorectal cancer(cT2-T4a, Nx, M0).
* Haven't received any chemotherapy or radiotherapy.
* Adequate organ function.
* All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment.
Exclusion Criteria:
* Is currently participating in a study of an investigational agent or using an investigational device;
* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy within 2 years prior to the first dose of study treatment;
* Has undergone major surgery within 30 days of Study Day 1;
* Has a known additional malignancy that is progressing or requires systemic treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
* Has known active central nervous system (CNS) metastases;
* Has carcinomatous meningitis;
* Has an active autoimmune disease that has required systemic treatment in the past…
What they're measuring
1
The rate of pathologic complete response(pCR%)
Timeframe: through study completion, an average of 1 year