Study of Lunresertib Alone or in Combination With RP-3500 or Debio 0123 in Patients With Advanced Solid Tumors

NCT04855656 · tracked via the Priya Life Science USA tracker

Sponsor

Debiopharm International SA

Phase

Phase 1

Started

2021-04-30

Last updated

2026-08-24

Condition(s) studied

Advanced Solid Tumor

Investigational drug(s) / intervention(s)

LunresertibRP-3500Debio0123

Lunresertib: Oral PKMYT1 Inhibitor

RP-3500: Oral ATR Inhibitor

Debio0123: Oral WEE1 Inhibitor

Study summary

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.

Eligibility

Sex

ALL

Min age

12 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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. 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. * 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.

Primary outcome measure(s)

Safety and Tolerability of lunresertib either in monotherapy or in combination with RP-3500 or with Debio 0123 in patients with eligible advanced solid tumors — Up to 90 days after last administration of study intervention
Assessed by treatment-emergent adverse events (TEAEs), physical examinations (PEs), safety laboratory assessments, electrocardiograms (ECGs), and vital sign measurements
To define the MTD of lunresertib monotherapy, and determine a recommended Phase 2 dose (RP2D) and preferred schedule — Up to 90 days after last administration of study intervention
Assessed by the incidence of Dose-limiting toxicities (DLTs) and the incidence and severity of cumulative safety data
To define the MTD of lunresertib in combination with RP-3500 or in combination with Debio 0123, and determine a recommended Phase 2 dose (RP2D) and preferred schedule — Up to 90 days after last administration of study intervention
Assessed by the incidence of dose-limiting toxicities (DLTs) and the incidence and severity of cumulative safety data
The relative bioavailability of lunresertib capsule formulation as compared to lunresertib tablet formulation in the fasted state — Time 0 (time of dosing) to 72 hours post-dose for each treatment condition
Assessed by the plasma concentrations of lunresertib with calculation of pharmacokinetic (PK) parameters including maximum observed plasma concentration (Cmax), time to maximum observed plasma concentration (Tmax), area under the plasma concentration-time curve (AUC) , for both formulations in the fasted state.
The effect of food on the PK of tablet formulation of lunresertib when administered in fed conditions compared to administration under fasted conditions — Time 0 (time of dosing) to 72 hours post-dose for each treatment condition
Assessed by the plasma concentrations of lunresertib with calculation of the ratio of PK parameters (e.g., Cmax and AUC) between the tablet formulation under fasted and fed state.
To assess the safety and tolerability of lunresertib tablets in combination with RP-3500, confirm the MTD of lunresertib tablets in combination with RP-3500, and determine a RP2D and preferred schedule — Up to 90 days after last administration of study intervention
Assessed by DLTs, TEAEs, safety laboratory assessments, the incidence of DLTs and the incidence and severity of cumulative safety data

Trial sites (26)

Facility	City	Region	Status
# 1019, UCLA, Westwood Cancer Center	Los Angeles	California	Completed
#1025, University of California San Francisco	San Francisco	California	Recruiting
#1012, Yale	New Haven	Connecticut	Recruiting
#1017, Mayo Clinic	Jacksonville	Florida	Recruiting
#1002, Dana Farber Cancer Institute	Boston	Massachusetts	Recruiting
#1023, START Midwest	Grand Rapids	Michigan	Recruiting
#1016, Mayo Clinic	Rochester	Minnesota	Recruiting
#1011, Washington University	St Louis	Missouri	Recruiting
#1032, Northwell Health Cancer Institute	New Hyde Park	New York	Recruiting
#1008, Columbia University	New York	New York	Completed
#1004, Memorial Sloan Kettering Cancer Institute	New York	New York	Recruiting
#1010, University of Pennsylvania	Philadelphia	Pennsylvania	Completed
#1007, Rhode Island Hospital	Providence	Rhode Island	Recruiting
#1030, Women & Infants Hospital of Rhode Island	Providence	Rhode Island	Recruiting
#1001, The University of Texas M.D. Anderson Cancer Center	Houston	Texas	Recruiting
#1013, The University of Utah	Salt Lake City	Utah	Recruiting
#1027, University of Virginia	Charlottesville	Virginia	Recruiting
#2002, The Hospital for Sick Children	Toronto	Ontario	Completed
#2001, Princess Margaret Cancer Centre	Toronto	Ontario	Recruiting
#2003, The Research Institute of the McGill University Health Centre	Montreal	Quebec	Completed
#4001, Rigshospitalet - Blegdamsvej	Copenhagen	Denmark	Recruiting
Clinica Universidad de Navarra	Madrid	Spain	Not Yet Recruiting
START Madrid. Hospital Fundación Jimenez Diaz	Madrid	Spain	Recruiting
Hospital Universitario HM Sanchinarro	Madrid	Spain	Recruiting
Clinica Universidad de Navarra	Navarra	Spain	Not Yet Recruiting
#3003, Sarah Cannon Research Institute	London	United Kingdom	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04855656 on ClinicalTrials.gov ↗ ← All trials in the USA