Study of Lunresertib Alone or in Combination With RP-3500 or Debio 0123 in Patients With Advanced Solid Tumors
NCT ID: NCT04855656
Last Updated: 2026-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
464 participants
INTERVENTIONAL
2021-04-30
2028-06-30
Brief Summary
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Detailed Description
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* Evaluate the safety profile and MTD of lunresertib alone and in combination with RP-3500 or in combination with Debio 0123 when administered orally to establish the recommended Phase 2 dose and schedule
* Characterize the PK and pharmacodynamics of lunresertib alone and in combination with RP-3500 or in combination with Debio 0123
* Assess preliminary anti-tumor activity associated with lunresertib alone and in combination with RP-3500 or in combination with Debio 0123
This study was previously posted by Repare Therapeutics. In September 2025, sponsorship of the trial was transferred to Debiopharm International S.A
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Phase 1: Lunresertib Single-Agent, Dose Escalation and Food-effect Study
Patients receive lunresertib orally until disease progression, unacceptable toxicity, or investigator/patient decision. Dose escalation will proceed until a maximum tolerated dose is identified.
Lunresertib
Oral PKMYT1 Inhibitor
Phase 1: Lunresertib in combination with RP-3500, Dose Escalation Study
Patients receive lunresertib with RP-3500 orally until disease progression, unacceptable toxicity, or investigator/patient decision. Dose escalation will proceed until a maximum tolerated dose is identified.
Lunresertib
Oral PKMYT1 Inhibitor
RP-3500
Oral ATR Inhibitor
Phase 1: Lunresertib in combination with Debio 0123, Dose Escalation Study
Patients receive lunresertib with Debio 0123 orally until disease progression, unacceptable toxicity, or investigator/patient decision. Dose escalation will proceed until a maximum tolerated dose is identified.
Lunresertib
Oral PKMYT1 Inhibitor
Debio0123
Oral WEE1 Inhibitor
Interventions
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Lunresertib
Oral PKMYT1 Inhibitor
RP-3500
Oral ATR Inhibitor
Debio0123
Oral WEE1 Inhibitor
Eligibility Criteria
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Inclusion Criteria
* Lansky performance status ≥50% for patients ≤16 years of age, or ECOG score of 0, 1, (or 2 for module 1) for patients \>16 years of age.
* Locally advanced or metastatic resistant or refractory solid tumors.
* Patients \<18 years of age must weigh at least 40 kg.
* Submission of available tumor tissue at screening or willingness to have a biopsy performed if safe and feasible
* Next generation sequencing (NGS) report obtained in a CLIA-certified or equivalent laboratory demonstrating eligible tumor biomarker.
* CCNE1 amplification (non-equivocal) as determined by either a tumor or plasma NGS test, or FISH
* FBXW7 deleterious mutations identified by either a tumor or plasma NGS test
* PPP2R1A deleterious mutations identified by either a tumor or plasma NGS test
* Measurable disease as per RECIST v1.1. For certain modules, patients with prostate cancer or ovarian cancer that have non-measurable disease but have elevated tumor markers (PSA or CA-125, respectively) can also be eligible
* 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.
* Any prior radiation must have been completed at least 7 days prior to the start of study drugs, and patients must have recovered from any acute adverse effects prior to the start of study treatment.
Exclusion Criteria
* 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 dose of lunresertib.
* Uncontrolled, symptomatic brain metastases.
* Uncontrolled hypertension.
* Certain prior anti-cancer therapy
* Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.
12 Years
ALL
No
Sponsors
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Debiopharm International SA
INDUSTRY
Responsible Party
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Locations
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#1016, Mayo Clinic
Phoenix, Arizona, United States
# 1019, UCLA, Westwood Cancer Center
Los Angeles, California, United States
#1025, University of California San Francisco
San Francisco, California, United States
#1012, Yale
New Haven, Connecticut, United States
#1017, Mayo Clinic
Jacksonville, Florida, United States
#1002, Dana Farber Cancer Institute
Boston, Massachusetts, United States
#1023, START Midwest
Grand Rapids, Michigan, United States
#1011, Washington University
St Louis, Missouri, United States
#1032, Northwell Health Cancer Institute
New Hyde Park, New York, United States
#1008, Columbia University
New York, New York, United States
#1004, Memorial Sloan Kettering Cancer Institute
New York, New York, United States
#1010, University of Pennsylvania
Philadelphia, Pennsylvania, United States
#1007, Rhode Island Hospital
Providence, Rhode Island, United States
#1030, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States
#1001, The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
#1013, The University of Utah
Salt Lake City, Utah, United States
#1027, University of Virginia
Charlottesville, Virginia, United States
#2002, The Hospital for Sick Children
Toronto, Ontario, Canada
#2001, Princess Margaret Cancer Centre
Toronto, Ontario, Canada
#2003, The Research Institute of the McGill University Health Centre
Montreal, Quebec, Canada
#4001, Rigshospitalet - Blegdamsvej
Copenhagen, , Denmark
#3003, Sarah Cannon Research Institute
London, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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RP-6306-01
Identifier Type: OTHER
Identifier Source: secondary_id
Debio 0123-106
Identifier Type: -
Identifier Source: org_study_id
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