Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug combo targets Hard-to-Treat cancers in early trial

NCT ID NCT05838768

Disease control Sponsor: Novartis Pharmaceuticals 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tests a new drug called HRO761, alone or combined with pembrolizumab or irinotecan, in people with advanced solid tumors that have high microsatellite instability (MSI-high) or mismatch repair deficiency (dMMR). The main goals are to check safety and find the best dose. About 123 participants whose cancers have not responded to prior treatments will take part.

What this could mean

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

Active substance
HRO761 (tablet), pembrolizumab (infusion), irinotecan (infusion)
What this could lead to
If successful, this could point toward a new treatment option for people with advanced cancers that have specific genetic markers (MSI-high or dMMR).
What could go wrong
This is an early Phase 1 trial with only 123 participants, focused on safety and dosing. It is too soon to know if HRO761 will work, and side effects are unknown.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

123 people

The number who actually took part.

Started

Jun 2023

Expected to finish

Aug 2027

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 to 100 years

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.

Key Inclusion criteria: * Patients with advanced unresectable or metastatic MSIhi or MMR deficient (dMMR) solid tumors who have progressed after or are intolerant to prior standard therapy. * Arm A and C: Patients must have progressed on the most recent therapy for advanced disease including one prior line of immune checkpoint inhibitor therapy. * Arm B: Patients should have received prior chemotherapy or targeted therapy, and patients should have received prior immune checkpoint inhibitor or should be expected to benefit from immune checkpoint inhibitor therapy. * Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 * Measurable disease as determined by RECIST version 1.1 * • All patients (Arm A, B and C) will have available archival tumor tissue obtained prior to study treatment initiation, to allow retrospective MSIhi/dMMR status confirmation. A newly obtained biopsy will only be collected at screening if there is no archival tumor tissue available and if safe and medically feasible according to treating institution's guidelines. Exceptions may be considered after documented discussion with Novartis. Key Exclusion criteria: * Impaired cardiac function or clinically significant cardiac disease * Clinically significant eye impairment * Patients with a primary Central Nervous System (CNS) tumor or tumor metastatic to the CNS * Human Immunodeficiency Virus (HIV) infection * Active Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Tuberculosis infection. Patients whose disease is controlled under antiviral therapy should not be excluded. * History of severe hypersensitivity reactions to any ingredient of study drug(s) * Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs (e.g., severe ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection), except for prior gastrectomy. Other protocol-defined inclusion/exclusion criteria may apply

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Msihi or DMMR advanced unresectable or metastatic solid tumors, including colorectal cancers are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm mismatch repair cancer syndrome 1 Neoplasm Metastasis

As listed by the trial registrant

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

Msihi or DMMR advanced unresectable or metastatic solid tumors, including colorectal cancers

Contacts and locations

Locations

  • Columbia University Medical Ctr

    New York, New York, 10032, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Memorial Sloan Kettering

    New York, New York, 10017, United States

  • Novartis Investigative Site

    Brussels, 1200, Belgium

  • Novartis Investigative Site

    Beijing, 100036, China

  • Novartis Investigative Site

    Guangzhou, 510655, China

  • Novartis Investigative Site

    Bordeaux, 33076, France

  • Novartis Investigative Site

    Marseille, 13273, France

  • Novartis Investigative Site

    Toulouse, 31059, France

  • Novartis Investigative Site

    Essen, 45147, Germany

  • Novartis Investigative Site

    Tel Aviv, 6423906, Israel

  • Novartis Investigative Site

    Milan, MI, 20162, Italy

  • Novartis Investigative Site

    Rozzano, MI, 20089, Italy

  • Novartis Investigative Site

    Kashiwa, Chiba, 2778577, Japan

  • Novartis Investigative Site

    Oslo, 0310, Norway

  • Novartis Investigative Site

    Singapore, 119228, Singapore

  • Novartis Investigative Site

    Seoul, 03722, South Korea

  • Novartis Investigative Site

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    Madrid, 28009, Spain

  • Novartis Investigative Site

    Madrid, 28040, Spain

  • Novartis Investigative Site

    Valencia, 46010, Spain

  • Novartis Investigative Site

    Stockholm, 17176, Sweden

  • Novartis Investigative Site

    Taipei, 10002, Taiwan

  • Novartis Investigative Site

    London, SW3 6JJ, United Kingdom

  • Novartis Investigative Site

    Oxford, OX3 7LE, United Kingdom

  • UCSF

    San Francisco, California, 94115, United States

  • Univ of TX MD Anderson Cancer Cntr

    Houston, Texas, 77030, United States

  • University of California LA

    Los Angeles, California, 90095, United States