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Experimental cancer combo trial halted early

NCT ID NCT05147350

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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tested a new drug called RP-6306 combined with standard chemotherapy (FOLFIRI) in 38 adults with advanced solid tumors that had stopped responding to other treatments. The goal was to check safety, find the best dose, and see if the combo could shrink tumors. However, the study was terminated early, so no final results are available.

What this could mean

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

Active substance
RP-6306 (a PKMYT1 inhibitor) combined with FOLFIRI chemotherapy
What this could lead to
If successful, this could point toward a new combination treatment for advanced solid tumors that have stopped responding to standard therapy.
What could go wrong
This was a very early (Phase 1) trial that was terminated, so no conclusions can be drawn. The combination may cause significant side effects, and it is unclear if it will work in larger studies.

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

38 people

The number who actually took part.

Started

Aug 2022

Finished

Feb 2025

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: * Male or female and ≥18 years-of-age at the time of signature of the informed consent * Confirmed advanced solid tumors resistant or refractory to standard treatment * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. * All patients must have locally advanced or metastatic CRC, GI, or esophageal cancer(s) and radiographic evidence of progressing disease. * Measurable disease as per RECIST v1.1 * Submission of available tumor tissue or willingness to have a biopsy performed if safe and feasible * Acceptable hematologic and organ function at screening * Negative pregnancy test for women of childbearing potential at Screening and prior to first study drug. Exclusion Criteria: * Inability to swallow and retain oral medications. * Chemotherapy or small molecule antineoplastic agent given within 21 days or \<5 half- lives, whichever is shorter, prior to first dose of study treatment. * History or current condition, therapy, or laboratory abnormality that might confound the study results, or interfere with the patient's participation for the full duration of the study treatment. * Patients who are pregnant or breastfeeding * Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction or other reasons which, in the investigator's opinion, could compromise the participating patient's safety. * Major surgery within 4 weeks prior to first study treatment dose. * Uncontrolled, symptomatic brain metastases. * Uncontrolled high blood pressure * Active, uncontrolled bacterial, fungal, or viral infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS) related illness. * Moderate or severe hepatic impairment * Cardiac diseases currently or within the last 6 months as defined by New York Heart Association (NYHA) ≥Class 2 * Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • # 2001, Princess Margaret Cancer Centre

    Toronto, Ontario, ON M5G 2M9, Canada

  • # 3003, Sarah Cannon Research Institute

    London, W1G 6AD, United Kingdom

  • # 5002, South Texas Accelerated Research Therapeutics

    Madrid, Spain

  • # 5003, Hospital Universitario HM Sanchinarro

    Madrid, Spain

  • #1001, The University of Texas M.D. Anderson Cancer Center

    Houston, Texas, 77030, United States

  • #1008, Columbia University

    New York, New York, 10032, United States

  • #1013, The University of Utah, Huntsman Cancer Center

    Salt Lake City, Utah, 84112, United States

  • #1019, UCLA, Westwood Cancer Center

    Los Angeles, California, 90095, United States

  • #1022, Moffitt Cancer Center

    Tampa, Florida, 33612, United States

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