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Porustobart + Pembrolizumab for Colon Cancer

Not yet recruiting at 27 trial locations
MM
Overseen ByMedical Monitor
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Solstice Oncology, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

This trial is for adults with a type of colon cancer called microsatellite stable (MSS) that can be removed by surgery and has not spread. Participants must be healthy enough for surgery and able to receive immune-based treatments.

Inclusion Criteria

I have a tumor tissue sample and pathology report available.
Reproductive status/contraception requirements per protocol
I am 18 years old or older.
See 4 more

Exclusion Criteria

I have had severe allergic reactions to certain antibody drugs or serious lung problems.
I have not taken any experimental drugs in the past 3 weeks.
I do not need urgent surgery soon.
See 4 more

What Are the Treatments Tested in This Trial?

Interventions

  • Pembrolizumab
  • Porustobart

Trial Overview

The study tests two medicines, pembrolizumab and porustobart, given before surgery to see if they shrink MSS colon cancer. All participants get pembrolizumab; one group gets one dose of porustobart, the other gets two doses. The goal is to find the best schedule.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Arm 2Experimental Treatment2 Interventions
Group II: Arm 1Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Solstice Oncology, Inc.

Lead Sponsor

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