Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsPhase1

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

Sponsor: Debiopharm International SA

NCT ID: NCT04855656

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Lunresertib (drug), RP-3500 (drug), Debio0123 (drug)
How long the study runs
Study runs about 86 months (dates as stated)
About the drug or intervention
Lunresertib — drug: Oral PKMYT1 Inhibitor · RP-3500 — drug: Oral ATR Inhibitor · Debio0123 — drug: Oral WEE1 Inhibitor
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
12 Years and over
Who
All
Number of participants
464
Started
2021-04-30
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for advanced solid tumor
  • • Phase1 - 464 participants
  • • 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

Who can take part?

  • • Ages 12 Years and over
  • • Diagnosed with advanced solid tumor

Where?

  • • London - #3003, Sarah Cannon Research Institute

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

Phase 1/1b, multi-center, open-label, dose-escalation study to: * 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 Expanded Access Status: There is no expanded access program available for the investigational products in this study at this time.

Advanced Solid Tumor

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 12 Years and over
  • Who can join: All genders

Biomarkers mentioned

PSACA-125

Treatment history

Treatments you must have had:

  • ✓ or surgical procedures
  • ✓ been completed at least 7 days

What the study is looking for

  • ✓Male or female and ≥12 years-of-age at the time of agreement to take part.
  • ✓Lansky performance status ≥50% for patients ≤16 years of age, or ECOG score of 0, 1, (or 2 for module 1) for...
  • ✓that has grown locally or that has spread 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

Who cannot take part

  • ✗drug treatment or small molecule antineoplastic agent given within 21 days or \<5 half-lives, whichever is shorter,...
  • ✗History or current condition, therapy, or laboratory abnormality that might confound the study results or interfere...
  • ✗Patients who are pregnant or breastfeeding.
  • ✗Major surgery within 4 weeks prior to first dose of lunresertib.
  • ✗Uncontrolled, causing symptoms brain metastases.
See the full criteria
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.

Where Is This Study? (1 UK site)

#3003, Sarah Cannon Research Institute

London W1G 6AD, United Kingdom

Recruiting

How to Get in Touch

Debiopharm International S.A

Sponsor contact

CONTACT

+41 21 321 01 11 clinicaltrials@debiopharm.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09