Study of Lunresertib Alone or in Combination With RP-3500 or Debio 0123 in Patients With Advanced Solid Tumors
Recruiting now · Phase 1
Conditions studied: Advanced Solid Tumor
In brief
The primary purpose of this study is to assess the safety and tolerability of lunresertib alone and in combination with RP-3500 or in combination with Debio 0123 in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) and assess preliminary anti-tumor activity.
Key facts
- Study ID
- NCT04855656
- Run by
- Debiopharm International SA
- People needed
- 464
- Starts
- 2021-04-30
- Expected to finish
- 2028-06-01
- Last updated by the study team
- 2026-07-24
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female and ≥12 years-of-age at the time of informed consent.
- 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.
You may not qualify if…
- 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.
- 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.
Where it is running
- #1017, Mayo Clinic — Jacksonville, Florida, United States (enrolling)
- #2001, Princess Margaret Cancer Centre — Toronto, Ontario, Canada (enrolling)
- #1002, Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
- #4001, Rigshospitalet - Blegdamsvej — Copenhagen, Denmark (enrolling)
- #3003, Sarah Cannon Research Institute — London, United Kingdom (enrolling)
- #1023, START Midwest — Grand Rapids, Michigan, United States (enrolling)
- #1016, Mayo Clinic — Rochester, Minnesota, United States (enrolling)
- #1011, Washington University — St Louis, Missouri, United States (enrolling)
- #1032, Northwell Health Cancer Institute — New Hyde Park, New York, United States (enrolling)
- #1025, University of California San Francisco — San Francisco, California, United States (enrolling)
- #1004, Memorial Sloan Kettering Cancer Institute — New York, New York, United States (enrolling)
- #1012, Yale — New Haven, Connecticut, United States (enrolling)
- #1007, Rhode Island Hospital — Providence, Rhode Island, United States (enrolling)
- #1030, Women & Infants Hospital of Rhode Island — Providence, Rhode Island, United States (enrolling)
- #1001, The University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States (enrolling)
- #1013, The University of Utah — Salt Lake City, Utah, United States (enrolling)
- #1027, University of Virginia — Charlottesville, Virginia, United States (enrolling)
- #1010, University of Pennsylvania — Philadelphia, Pennsylvania, United States
- #1008, Columbia University — New York, New York, United States
- # 1019, UCLA, Westwood Cancer Center — Los Angeles, California, United States
- #2002, The Hospital for Sick Children — Toronto, Ontario, Canada
- #2003, The Research Institute of the McGill University Health Centre — Montreal, Quebec, Canada
Full record on ClinicalTrials.gov
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