Actively Recruiting
Study of Lunresertib Alone or in Combination With RP-3500 or Debio 0123 in Patients With Advanced Solid Tumors
Led by Debiopharm International SA · Updated on 2026-04-20
464
Participants Needed
22
Research Sites
369 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study of Lunresertib Alone or in Combination With RP-3500 or Debio 0123 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 12 years or older at informed consent
- Lansky performance status 50% or higher for patients 16 years or younger, or ECOG score of 0, 1, or 2 (for module 1) for patients over 16 years
- Diagnosis of locally advanced or metastatic resistant or refractory solid tumors
- Patients under 18 years must weigh at least 40 kg
- Submission of available tumor tissue at screening or willingness to have a biopsy if safe
- Next generation sequencing report from a certified lab showing eligible tumor biomarker
- Presence of CCNE1 amplification, FBXW7 deleterious mutations, or PPP2R1A deleterious mutations as determined by tumor or plasma tests
- Measurable disease by RECIST v1.1; patients with certain prostate or ovarian cancers with elevated tumor markers also eligible
- Ability to swallow and retain oral medications
- Acceptable blood and organ function at screening
- Negative pregnancy test for women of childbearing potential
- Resolution of all toxicities from prior therapy or surgery
- Completion of any prior radiation at least 7 days before starting study drugs and recovery from acute effects
You will not qualify if you...
- Chemotherapy or small molecule antineoplastic treatment within 21 days or less than 5 half-lives before first dose
- Any history or current condition, therapy, or lab abnormality that could affect study results or participation
- Pregnant or breastfeeding women
- Life-threatening illness, uncontrolled infection, organ dysfunction, or other safety concerns
- Major surgery within 4 weeks before first dose
- Uncontrolled symptomatic brain metastases
- Uncontrolled high blood pressure
- Certain prior anti-cancer therapies
- Psychological, familial, sociological, or geographical conditions preventing protocol compliance or follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 22 locations
1
# 1019, UCLA, Westwood Cancer Center
Los Angeles, California, United States, 90095
Completed
2
#1025, University of California San Francisco
San Francisco, California, United States, 94158
Actively Recruiting
3
#1012, Yale
New Haven, Connecticut, United States, 06520
Actively Recruiting
4
#1017, Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
5
#1002, Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
6
#1023, START Midwest
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
7
#1016, Mayo Clinic
Rochester, Minnesota, United States, 55902
Actively Recruiting
8
#1011, Washington University
St Louis, Missouri, United States, 63130
Actively Recruiting
9
#1032, Northwell Health Cancer Institute
New Hyde Park, New York, United States, 11042
Actively Recruiting
10
#1008, Columbia University
New York, New York, United States, 10032
Completed
11
#1004, Memorial Sloan Kettering Cancer Institute
New York, New York, United States, 10065
Actively Recruiting
12
#1010, University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Completed
13
#1007, Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
14
#1030, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02903
Actively Recruiting
15
#1001, The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
16
#1013, The University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
17
#1027, University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
18
#2002, The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Completed
19
#2001, Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2C1
Actively Recruiting
20
#2003, The Research Institute of the McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1
Completed
21
#4001, Rigshospitalet - Blegdamsvej
Copenhagen, Denmark
Actively Recruiting
22
#3003, Sarah Cannon Research Institute
London, United Kingdom, W1G 6AD
Actively Recruiting
Research Team
D
Debiopharm International S.A
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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