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Study of Lunresertib for Advanced Solid Tumors

This study is testing a new medicine called Lunresertib, either by itself or in combination with other medicines called RP-3500 or Debio 0123. These medicines are designed to treat advanced solid tumors (cancers that form in solid organs like the breast or lung). The main goal is to find out how safe these medicines are and what dose works best. Researchers will also look for any early signs that the medicines are helping to shrink tumors. You may be able to join if you are at least 12 years old, have advanced solid tumors that are resistant or have come back after previous treatments, and meet certain health requirements. The study is currently recruiting patients.

Study design
This is an open-label, dose-escalation study, meaning you and your doctors will know which medicine you are receiving. It plans to enroll 464 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety and tolerability will be measured for up to 90 days after your last dose of the study medicine.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04855656

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

Recruiting
PHASE1Ages 12+InterventionalTreatment
Debiopharm International SA
~464 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:LunresertibRP-3500Debio0123

At a glance

Recruiting sites
19 of 26 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over Up to 90 days after last administration of study intervention
+5 more outcomes measured

Conditions

Advanced Solid Tumor

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Where it's being run

26 sites across 18 states
Spain4
New York3
California2
Rhode Island2
Ontario2
Connecticut1
Florida1
Massachusetts1

Who to contact

Debiopharm International S.A
[email protected]
+41 21 321 01 11
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Safety and Tolerability of lunresertib either in monotherapy or in combination with RP-3500 or with Debio 0123 in patients with eligible advanced solid tumorsUp 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 scheduleUp 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 scheduleUp 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 stateTime 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 conditionsTime 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 scheduleUp 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