Experimental cancer combo shows early promise, but trial halted
NCT ID NCT05147272
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase study tested a new oral drug (RP-6306) combined with the chemotherapy gemcitabine in 67 adults with advanced solid tumors that had stopped responding to other treatments. The main goals were to check safety, find the best dose, and see if the combination could shrink tumors. The trial was terminated early, so final results are limited.
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 gemcitabine
- What this could lead to
- If successful, this combination could offer a new treatment option for people with advanced solid tumors that have stopped responding to standard therapies.
- What could go wrong
- This was a very early (Phase 1) trial that was terminated, so results are limited. The combination may cause significant side effects, and it is unclear if it will work for most patients.
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
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67 people
The number who actually took part.
- Started
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Dec 2021
- Finished
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Aug 2024
- 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
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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 informed consent. * ECOG Performance status 0 or 1. * Locally advanced or metastatic resistant or refractory solid tumors. * Submission of available tumor tissue at screening or willingness to have a biopsy performed if safe and feasible. * Measurable disease as per RECIST v1.1. * Ability to swallow and retain oral medications. * Acceptable hematologic and organ function at screening. * Negative pregnancy test (serum) for women of childbearing potential (WOCBP) at Screening. * Resolution of all toxicities of prior therapy or surgical procedures. * Life expectancy ≥12 weeks after the start of the treatment Exclusion Criteria: * Chemotherapy or small molecule antineoplastic agent given within 21 days or \<5 half- lives, whichever is shorter, prior to first dose of study drug. * 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. * Known sensitivity to any of the ingredients of RP-6306 or gemcitabine. * 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 dose of RP-6306 and gemcitabine. * Uncontrolled, symptomatic brain metastases. * Uncontrolled hypertension. * Moderate or severe hepatic impairment * 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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# 1004, Memorial Sloan Kettering Cancer Institute
New York, New York, 10065, United States
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# 1008, Columbia University
New York, New York, 10032, United States
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# 1010, University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
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# 1016, Mayo Clinic
Rochester, Minnesota, 55902, United States
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# 1017, Mayo Clinic
Jacksonville, Florida, 32224, United States
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# 1018, Mayo Clinic
Phoenix, Arizona, 85054, 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
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# 1023, START Midwest
Grand Rapids, Michigan, 49546, United States
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# 2001, Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2C1, Canada
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# 3003, Sarah Cannon Research Institute
London, United Kingdom
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