CI

At a glance

ClinicalIndex Comparison Record
Phase 2Terminated· 6 enrolled
Drug / intervention
AK104drug
Likely dose
AK104 6 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04547101
NCT04547101Phase 2Terminated
Terminated
CompareCT.gov

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

Akeso·interventional·Posted Sep 14, 2020·Updated Oct 19, 2022

In Brief

A Phase 2 clinical trial evaluating AK104 for MSI-H/dMMR Solid Tumor. Terminated early, enrolled 6 participants across 1 site.

Signals

Trial was terminated early

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMSI-H/dMMR Solid Tumor
CountriesChina
CollaboratorsAkeso Pharmaceuticals, Inc.

Timeline

Phase 2TerminatedFinished
202120222023202420252026
First PostedSep 14, 2020
Enrollment StartApr 24, 2020
Primary CompletionSep 30, 2022
TodayJul 1, 2026
Enrollment to primary: 2.4 yearsPosted 5.8 years ago

Interventions

AK104drug

AK104，6 mg/kg IV，every 2 weeks (Q2W)