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Colon CancerCancerDrugPhase 2

What this study is

The goal of this clinical trial is to learn if giving two medicines together, porustobart and pembrolizumab, before surgery can treat a common type of colon cancer called microsatellite stable (MSS) colon cancer in adults. This type of cancer can be removed with surgery and has not spread to other parts of the body. Both medicines work by helping the immune system fight cancer.

The main questions this study wants to answer:

How well do the medicines destroy the cancer before surgery? What side effects do participants have when taking the medicines?

Researchers will compare two groups to see which treatment schedule works better and is safer. Both groups get pembrolizumab. One group gets one dose of porustobart (Day 1 only), and the other group gets two doses (Day 1 and Day 22).

Participants will:

Complete certain tests and procedures to make sure they are eligible Get the medicines through a vein on Day 1 and Day 22 then have surgery 6-9 weeks after starting treatment Return for checkups and tests every 6 months for up to 3 years after surgery

What's being tested

  • Pembrolizumab

    Intervention · DRUG

  • Porustobart

    Intervention · DRUG

Both interventions

Administered to: Dose Schedule 1 - Porustobart + Pembrolizumab, Dose Schedule 2 - Porustobart + Pembrolizumab

Study details

Official title
A Phase 2, Open-Label, Multicenter, Randomized Trial Evaluating the Efficacy and Safety of Different Schedules of Neoadjuvant Pembrolizumab and Porustobart in Patients With Resectable pMMR/MSS Colon Cancer
Sponsor
Solstice Oncology, Inc.
Conditions
Colon Cancer
Enrolling
100 people
Starts
2026-09-30
Est. completion
2029-09-30
Design
Open-label, randomized, parallel groups, Phase 2
Record
View on ClinicalTrials.gov ↗