Health TrialsbyHealthPanel

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

ConditionsMetastatic Colorectal NeoplasmsMicrosatellite Stable / Proficient Mismatch Repair Colorectal Cancer
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Center Hospital East

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with histologically confirmed unresectable adenocarcinoma of the colon or rectum.

Confirmed microsatellite stable (MSS) or proficient mismatch repair (pMMR) status.

Presence of measurable disease according to RECIST version 1.1.

Age ≥ 18 years at the time of informed consent.

Disqualifiers

Prior treatment with fruquintinib for metastatic colorectal cancer.

Prior treatment with any anti-CCR8 antibody, regardless of indication.

Receipt of chemotherapy, radiotherapy, immunotherapy, or any antitumor therapy, or investigational agents within 14 days prior to enrollment, or persistence of CTCAE Grade ≥ 2 toxicities from prior therapies (excluding alopecia, hyperpigmentation, and peripheral sensory neuropathy).

History of acute coronary syndrome (including myocardial infarction or unstable angina), coronary angioplasty, or stent placement within 6 months prior to enrollment.

Trial design

Design model

Parallel

Treatments tested in this trial

  • S-531011

    Biological/Vaccine

    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/Vaccine

    Pembrolizumab will be administered intravenously at a dose of 200 mg once every 3 weeks (q3w).

Treatment groups

68 Participants
are divided into 2 treatment groups
Group A: Arm A S-531011 + FruquintinibExperimental treatment 2 interventions
Group B: Arm B S-531011 + Fruquintinib + PembrolizumabExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Dose-Limiting Toxicity (DLT) Rate [Phase Ib Part]

Percentage of participants experiencing dose-limiting toxicities (DLTs).

Time frame
Up to 29 days after first dose
2

Objective Response Rate (ORR) [Phase II Part]

Objective response rate assessed by the principal investigator or sub-investigator.Participants treated at the recommended dose in Phase Ib are included.

Time frame
From baseline to objective disease progression or death, assessed up to 24 months.

Secondary outcomes

1

Maximum Observed Serum Concentration of S-531011 (Cmax)

Maximum observed concentration of S-531011 in serum.

Time frame
From the first through the ninth administration of S-531011 (each cycle is 21 days) and at 30 days after the final administration
2

Time to Maximum Observed Serum Concentration of S-531011 (Tmax)

Time to reach the maximum observed serum concentration of S-531011.

Time frame
From the first through the ninth administration of S-531011 (each cycle is 21 days) and at 30 days after the final administration
3

Area Under the Serum Concentration-Time Curve of S-531011 (AUC)

Area under the serum concentration-time curve of S-531011.

Time frame
From the first through the ninth administration of S-531011 (each cycle is 21 days) and at 30 days after the final administration
4

Terminal Elimination Half-Life of S-531011 (t1/2)

Terminal elimination half-life of S-531011 estimated from serum concentration-time data.

Time frame
From the first through the ninth administration of S-531011 (each cycle is 21 days) and at 30 days after the final administration

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Cancer Center Hospital East

Lead sponsor

Shionogi

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: