Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can a Two-Drug immunotherapy combo shrink MSS colon cancer before surgery?

NCT ID NCT07808151

Disease control Sponsor: Solstice Oncology, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether giving two immunotherapy drugs, pembrolizumab and porustobart, before surgery can shrink tumors in adults with a common type of colon cancer called MSS (microsatellite stable) that has not spread. Participants receive the drugs through a vein, with one group getting a single dose of porustobart and the other getting two doses, followed by surgery 6 to 9 weeks later. Researchers compare the two schedules to see which is more effective at destroying cancer and to assess side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pembrolizumab (Keytruda) and porustobart (HBM4003), given together before surgery
What this could lead to
If this works, it could show that adding porustobart to pembrolizumab before surgery helps shrink MSS colon cancer more effectively, potentially leading to a new treatment approach for this common cancer type.
What could go wrong
This is a phase 2 trial with a relatively small number of participants, so results may not be definitive. The combination may cause side effects, and it is not yet known if the two-dose schedule is better than one dose.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: ≥18 years of age at consent Adenocarcinoma of the colon (rectosigmoid considered non-rectal); pMMR/MSS status Any T3 or T4, N any, M0; disease amenable to surgical resection ECOG Performance Status 0-1 Adequate tumor tissue sample with associated pathology report Adequate hematologic, hepatic, and renal function Reproductive status/contraception requirements per protocol Exclusion Criteria: Investigational agent within 3 weeks of first dose Imminent or urgent need for surgery Prior treatment with ICIs targeting CTLA-4, PD-1, or PD-L1 Systemic corticosteroid/immunosuppressive therapy within 1 week of first dose (exceptions apply) History of severe hypersensitivity to a fully human mAb; interstitial lung disease; pneumonitis requiring corticosteroids Active or history of autoimmune disease requiring systemic treatment within 2 years Major surgery within 4 weeks of first dose; active infection requiring treatment

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Colon cancer are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

colon carcinoma colonic neoplasm Spinocerebellar Degenerations type 1 diabetes mellitus 12

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colon cancer Microsatellite stable (MSS) colon cancer Proficient mismatch repair (PMMR) colon cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    30 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Investigator Site

    Los Angeles, California, 90033, United States

  • Investigator Site

    Tampa, Florida, 33612, United States

  • Investigator Site

    Chicago, Illinois, 60637, United States

  • Investigator Site

    Baltimore, Maryland, 21287, United States

  • Investigator Site

    Boston, Massachusetts, 02114, United States

  • Investigator Site

    New York, New York, 10016, United States

  • Investigator Site

    New York, New York, 10021, United States

  • Investigator Site

    New York, New York, 10027, United States

  • Investigator Site

    Cleveland, Ohio, 44106, United States

  • Investigator Site

    Nashville, Tennessee, 37232, United States

  • Investigator Site

    Seattle, Washington, 98109, United States

  • Investigator Site

    Anderlecht, Belgium

  • Investigator Site

    Bonheiden, Belgium

  • Investigator Site

    Ghent, Belgium

  • Investigator Site

    Leuven, Belgium

  • Investigator Site

    Liège, Belgium

  • Investigator Site

    Ostend, Belgium

  • Investigator Site

    Woluwe-Saint-Lambert, Belgium

  • Investigator Site

    Milan, Italy

  • Investigator Site

    Naples, Italy

  • Investigator Site

    Pisa, Italy

  • Investigator Site

    Amsterdam, Netherlands

  • Investigator Site

    Barcelona, Spain

  • Investigator Site

    L'Hospitalet de Llobregat, Spain

  • Investigator Site

    Madrid, Spain

  • Investigator Site

    Aberdeen, United Kingdom

  • Investigator Site

    Cardiff, United Kingdom

  • Investigator Site

    Glasgow, United Kingdom

  • Investigator Site

    Leeds, United Kingdom

  • Investigator Site

    London, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.