A Study of AK104 in Subjects With Locally Advanced Unresectable or Metastatic MSI-H/dMMR Solid Tuā¦ (NCT04547101) | Clinical Trial Compass
TerminatedPhase 2
A Study of AK104 in Subjects With Locally Advanced Unresectable or Metastatic MSI-H/dMMR Solid Tumors
Stopped: Due to difficuty of erollment and consideration of clinical guideline,The sponsor decided to stop study.
China6 participantsStarted 2020-04-24
Plain-language summary
It is a single-arm, open-label, multicenter, phase II study to evaluate the safety, efficacy, pharmacokinetics (PK) and immunogenicity of AK104 as a single agent in subjects with previously-treated locally advanced unresectable or metastatic MSI-H or dMMR solid tumors.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Have signed written informed consent form voluntarily.
* Male or female, age ā„ 18 years on the day of signing informed consent form.
* ECOG of 0 or 1.
* Estimated life expectancy of ā„3 months.
* Histologically or cytologically documented locally advanced unresectable or metastatic solid tumors.
* Confirmed MSI-H/dMMR status by the central laboratory.
* Have experienced documented disease progression during or after at least first-line therapy.
* Have radiologically measurable disease based on RECIST 1.1.
* Adequate organ function.
* Have agreed to take effective contraception from the date of signing the informed consent form until 120 days after the last administration.
Exclusion Criteria:
* Prior use of investigational products or devices within 4 weeks prior to C1D1 (Cycle 1 Day 1, the first dose of study drug).
* Presence of active autoimmune disease that have received systematic treatment in the past 2 years; or that is judged to be possibly relapsed or requires planned treatment by investigators.
* Active inflammatory bowel disease or that required treatment (e.g. Crohn's disease, ulcerative colitis or chronic diarrhea).
* Prior use of systematic corticosteroid (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to C1D1.
* Prior exposure to tumor immunotherapy, such as checkpoint inhibitors (eg. anti-PD-1, anti-PD-L1, anti-CTLA-4 antibody), checkpoint agonists or cellular therapy.
* Known history oā¦