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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (1 UK site)
#3003, Sarah Cannon Research Institute
London W1G 6AD, United Kingdom
How to Get in Touch
Debiopharm International S.A
Sponsor contactCONTACT
