A Single-arm, Open-label, Multicenter, Phase II Study of AK104, a PD-1/CTLA-4 Bispecific Antibody, in Subjects With Locally Advanced Unresectable or Metastatic Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Solid Tumors

Akeso1 site in 1 country6 target enrollmentApril 24, 2020

ConditionsMSI-H/dMMR Solid Tumor

InterventionsAK104

DrugsAK104

Overview

Phase: Phase 2
Intervention: AK104
Conditions: MSI-H/dMMR Solid Tumor
Sponsor: Akeso
Enrollment: 6
Locations: 1
Primary Endpoint: Objective response rate (ORR)
Status: Terminated
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

April 24, 2020

End Date

September 30, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Akeso

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Have signed written informed consent form voluntarily.
•Male or female, age ≥ 18 years on the day of signing informed consent form.
•ECOG of 0 or
•Estimated life expectancy of ≥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.
•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 C1D
•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 of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
•Known presence or history of interstitial lung disease.
•History of gastrointestinal perforation and/or fistula within 6 months prior to C1D
•Serious infections within 4 weeks prior to C1D
•Known presence of active tuberculosis.

Arms & Interventions

AK104

Intervention: AK104

Outcomes

Primary Outcomes

Objective response rate (ORR)

Time Frame: Up to 2 years

ORR is defined as the proportion of subjects with confirmed CR or PR, based on RECIST v1.1.

Secondary Outcomes

Disease control rate (DCR)(Up to 2 years)
Observed pharmacokinetics (PK) exposure of AK104(From first dose of AK104 through to 90 days after last dose of AK104)
Progression-free survival (PFS)(Up to 2 years)
Adverse events (AEs)(From first dose of AK104 through to 90 days after last dose of AK104)
Duration of response (DoR)(Up to 2 years)
Overall survival (OS)(Up to 2 years)
Number of subjects who develop detectable anti-drug antibodies (ADAs)(From first dose of AK104 through to 90 days after last dose of AK104)