Actively Recruiting
Testing the Combination of Two Anti-cancer Drugs, Peposertib (M3814) and Tuvusertib (M1774) for Advanced Solid Tumors
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
66
Participants Needed
6
Research Sites
116 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase I trial tests the safety, side effects and best dose of peposertib (M3814) in combination with tuvusertib (M1774) in treating patients with solid tumors that have spread to other places in the body (advanced). Peposertib and tuvusertib stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
CONDITIONS
Official Title
Testing the Combination of Two Anti-cancer Drugs, Peposertib (M3814) and Tuvusertib (M1774) for Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with confirmed metastatic or unresectable solid tumors lacking effective standard treatments
- Evidence of specific genetic mutations or amplifications (e.g., ATM, MYC, FBXW7, CCNE1, SWI/SNF mutations) approved by the principal investigator
- Progression after at least one prior standard therapy
- Age 18 years or older
- Life expectancy longer than 3 months
- ECOG performance status 0 to 2 (Karnofsky score of 60% or higher)
- Measurable disease by RECIST 1.1 (non-measurable allowed for dose escalation phase)
- Hemoglobin at least 9 g/dL
- Absolute neutrophil count at least 1,500/mcL
- Platelet count at least 100,000/mcL
- Total bilirubin no more than 1.5 times the upper limit of normal
- AST and ALT no more than 3 times the upper limit of normal (5 times if liver metastases present)
- Glomerular filtration rate at least 60 mL/min/1.73m2
- HIV patients on effective therapy with undetectable viral load within 6 months
- Patients with controlled hepatitis B or cured hepatitis C
- Prior or concurrent malignancies allowed if they do not interfere with study
- Cardiac function classified as New York Heart Association Class 2B or better
- Ability to swallow capsules or tablets
- Willingness to undergo paired biopsies (for expansion phase)
- Female patients of childbearing potential must have negative pregnancy test and agree to contraception
- Male patients of reproductive potential must agree to contraception
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- Immunotherapy within 21 days before starting study treatment
- Therapeutic radiation within 21 days or palliative radiation within 7 days before treatment
- Major surgery within 21 days before treatment
- Unresolved side effects greater than Grade 1 from prior cancer therapies, except for alopecia, controlled endocrine toxicity, or Grade 2 skin toxicity
- Use of other investigational agents
- Active or progressive brain metastases requiring immediate treatment
- Allergic reactions to peposertib or tuvusertib or similar compounds
- Inability to stop medications or supplements that strongly affect specific liver enzymes or drug transporters
- Inability to discontinue proton-pump inhibitors or certain acid-reducing medications during dosing periods
- Use of hematopoietic growth factors within 14 days before first dose
- Uncontrolled illnesses such as active infection, symptomatic heart failure, unstable angina, or arrhythmia
- QTcF interval of 470 milliseconds or more
- Pregnant or breastfeeding women
- Prior or concurrent malignancies that may interfere with safety or efficacy assessments unless approved by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
National Cancer Institute Developmental Therapeutics Clinic
Bethesda, Maryland, United States, 20892
Actively Recruiting
2
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Active, Not Recruiting
3
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Actively Recruiting
4
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
5
NYU Langone Hospital - Long Island
Mineola, New York, United States, 11501
Actively Recruiting
6
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States, 10016
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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