Recruiting
Phase 1

RP-6306, RP-3500, Debio 0123

Sponsor:

Debiopharm International SA

Code:

NCT04855656

Conditions

Advanced Solid Tumor

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

Lunresertib

RP-3500

Debio0123

Study Details

Brief 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.

Conditions

Advanced Solid Tumor

Study ID

NCT04855656

Start date

Apr 30, 2021

Status verified date

Aug, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

464 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

experimental: 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.

Interventions

Lunresertib

Oral PKMYT1 Inhibitor

RP-3500

Oral ATR Inhibitor

Debio0123

Oral WEE1 Inhibitor

Primary outcome measure

  • 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 [ Time Frame: Up to 90 days after last administration of study intervention ]
  • To define the MTD of lunresertib monotherapy, and determine a recommended Phase 2 dose (RP2D) and preferred schedule [ Time Frame: Up to 90 days after last administration of study intervention ]
  • 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 [ Time Frame: Up to 90 days after last administration of study intervention ]
  • The relative bioavailability of lunresertib capsule formulation as compared to lunresertib tablet formulation in the fasted state [ Time Frame: Time 0 (time of dosing) to 72 hours post-dose for each treatment condition ]
  • The effect of food on the PK of tablet formulation of lunresertib when administered in fed conditions compared to administration under fasted conditions [ Time Frame: Time 0 (time of dosing) to 72 hours post-dose for each treatment condition ]
  • 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 [ Time Frame: Up to 90 days after last administration of study intervention ]

Central Contacts and Locations

Central contacts

Debiopharm International S.A

+41 21 321 01 11clinicaltrials@debiopharm.com

Locations

#1025, University of California San Francisco

Recruiting

San Francisco, California, United States, 94158

#1012, Yale

Recruiting

New Haven, Connecticut, United States, 06520

#1017, Mayo Clinic

Recruiting

Jacksonville, Florida, United States, 32224

#1002, Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

#1023, START Midwest

Recruiting

Grand Rapids, Michigan, United States, 49503

#1016, Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55902

#1011, Washington University

Recruiting

St Louis, Missouri, United States, 63130

#1032, Northwell Health Cancer Institute

Recruiting

New Hyde Park, New York, United States, 11042

#1004, Memorial Sloan Kettering Cancer Institute

Recruiting

New York, New York, United States, 10065

#1007, Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

#1030, Women & Infants Hospital of Rhode Island

Recruiting

Providence, Rhode Island, United States, 02903

#1001, The University of Texas M.D. Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

#1013, The University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

#1027, University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

#2001, Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2C1

More Information

Sponsor

Debiopharm International SA

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Debiopharm International SA on 2026-08-24.