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Enzyme Inhibitor

Peposertib + Tuvusertib for Advanced Cancer

Phase 1
Recruiting
Led By Gregory M Cote
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial tests a new drug combo to stop the growth of advanced solid tumors by blocking enzymes needed for cell growth.

Who is the study for?
Adults with advanced solid tumors and specific genetic mutations (ATM, MYC, FBXW7, etc.) can join this trial. They must have a life expectancy over 3 months, good organ function, no major surgery or immunotherapy within the last 21 days, and not be on certain drugs that affect enzymes. HIV-positive patients on effective therapy are eligible.Check my eligibility
What is being tested?
The safety and optimal dosing of two anti-cancer drugs—Peposertib (M3814) and Tuvusertib (M1774)—are being tested in adults with advanced solid tumors. These drugs aim to stop tumor growth by blocking key enzymes needed for cell growth.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system's response to the drug, fatigue, digestive issues like nausea or diarrhea, blood-related problems such as anemia or clotting issues which could lead to bleeding or infections.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Incidence of dose limiting toxicity
Secondary outcome measures
Pharmacokinetic (PK) analysis
Other outcome measures
Overall response rate (ORR)
Pharmacodynamics (PD)
Progression free survival (PFS)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (peposertib, tuvusertib)Experimental Treatment7 Interventions
Patients receive peposertib PO in combination with tuvusertib PO QD or BID daily on days 1-14 of each cycle. Cycles repeat every 28 days in the absence of disease progression, pregnancy, non-compliance, unacceptable toxicity, termination of the study or the study drug is no longer available. Patients also undergo tumor biopsy before C1D1, C1D10 and at progression and blood sample collection during prestudy and weeks 1, 2, 3, 4, 5, 6, and at progression. Patients additionally undergo PET, CT, and MRI at baseline and are repeated every 8 weeks for 24 weeks then every 12 weeks unless clinically indicated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2720
Peposertib
2021
Completed Phase 1
~20
Positron Emission Tomography
2008
Completed Phase 2
~2210
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1720

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,717 Previous Clinical Trials
40,953,298 Total Patients Enrolled
Gregory M CotePrincipal InvestigatorDana-Farber - Harvard Cancer Center LAO
~44 spots leftby Aug 2024
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