Experimental cancer combo trial halted early
NCT ID NCT05147350
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
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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
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Feb 2025
- Lead sponsor
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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
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Anyone
- Healthy volunteers
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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 Hide 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
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# 2001, Princess Margaret Cancer Centre
Toronto, Ontario, ON M5G 2M9, Canada
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# 3003, Sarah Cannon Research Institute
London, W1G 6AD, United Kingdom
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# 5002, South Texas Accelerated Research Therapeutics
Madrid, Spain
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# 5003, Hospital Universitario HM Sanchinarro
Madrid, Spain
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#1001, The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
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#1008, Columbia University
New York, New York, 10032, United States
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#1013, The University of Utah, Huntsman Cancer Center
Salt Lake City, Utah, 84112, United States
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#1019, UCLA, Westwood Cancer Center
Los Angeles, California, 90095, United States
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#1022, Moffitt Cancer Center
Tampa, Florida, 33612, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Oral drug RVU120 put to the test against advanced solid tumors