A Multicenter, Phase Ib/II Clinical Trial to Evaluate the Efficacy and Safety of Concurrent Combination Therapy of S-531011 Plus Fruquintinib or S-531011 Plus Fruquintinib Plus Pembrolizumab in Patients With MSS/pMMR Colorectal Cancer

Sponsor
National Cancer Center Hospital East
Study ID
NCT07591597
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Metastatic Colorectal Neoplasms
  • Microsatellite Stable / Proficient Mismatch Repair Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • S-531011 — BIOLOGICAL
    S-531011 will be administered intravenously once every 3 weeks (q3w). In the Phase Ib part, A reduced dose of S-531011 may be used in Dose Level -1 according to the predefined dose-finding scheme by evaluating DLT profile. In the Phase II part, S-531011 will be administered at the recommended dose determined in the Phase Ib part.
  • Fruquintinib — DRUG
    Fruquintinib will be administered orally once daily on Days 1-21 of each 28-day cycle. In the Phase Ib part, fruquintinib will be started at 5 mg (Dose Level 0). A reduced dose of 4 mg may be used in Dose Level -1 according to the predefined dose-finding scheme by evaluating DLT profile. In the Phase II part, fruquintinib will be administered at the recommended dose determined in the Phase Ib part.
  • Pembrolizumab — BIOLOGICAL
    Pembrolizumab will be administered intravenously at a dose of 200 mg once every 3 weeks (q3w).

Study Details

This study aims to evaluate the efficacy and safety of the concurrent combination therapy of S 531011 + fruquintinib or S 531011 + fruquintinib + pembrolizumab in patients with MSS/pMMR colorectal cancer.

Key Dates

Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
Jul 31, 2027
Completion
May 31, 2029

Study Design

Enrollment
68 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A S-531011 + Fruquintinib
    Participants receive S-531011 and fruquintinib. In the Phase Ib part, dose levels may vary according to the dose finding scheme. In Phase II, the recommended dose determined in Phase Ib will be used.
  • Experimental: Arm B S-531011 + Fruquintinib + Pembrolizumab
    Participants receive S-531011, fruquintinib, and pembrolizumab. In the Phase Ib part, dose levels of S-531011 and fruquintinib may vary according to the dose finding scheme. In Phase II, the recommended dose determined in Phase Ib will be used. Pembrolizumab is administered at a fixed dose throughout both the Phase Ib and Phase II parts.

Primary Outcome Measure

Dose-Limiting Toxicity (DLT) Rate [Phase Ib Part] [ Time Frame: Up to 29 days after first dose ]

Central Contacts