Trial intelligence / Profile preview

Tislelizumab + Fruquintinib in ARID1A-mutated MSS mCRC

NCT05690035Phase 2

Key facts

Status
Withdrawn
Start
Jul 2025
Primary completion
Jul 2025
Countries
1
Sponsor
Sun Yat-sen University
Modality
Fragment-Derived Small Molecules, Monoclonal Antibodies, Orthosteric Ligands
Conditions
metastatic colorectal cancer (mCRC)
01

Overview

Phase 2, open-label, single-arm trial of tislelizumab and fruquintinib in metastatic colorectal cancer (mCRC), sponsored by Sun Yat-sen University. Primary endpoint: Objective Response Rate up to 3 years. Planned start Jul 2025; status: withdrawn.

02

Design

1 arm
Study design
Non-randomizedOpen-label
  • Tislelizumab + Fruquintinib

    Combination therapy with Tislelizumab and Fruquintinib.

03

Who it enrols

Patients with ARID1A-mutated pMMR/MSS metastatic colorectal cancer who have failed at least 2 lines of standard chemotherapy.

04

Endpoints

Primary

  • Objective Response Rate

Secondary

  • Progression-Free Survival

  • Overall Survival

  • Disease Control Rate

  • Incidence of Treatment-Emergent Adverse Events

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