Testing the Combination of Two Anti-cancer Drugs, Peposertib (M3814) and Tuvusertib (M1774) for Advanced Solid Tumors

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT05687136
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Malignant Solid Neoplasm
  • Metastatic Malignant Solid Neoplasm
  • Unresectable Malignant Solid Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo tissue biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Peposertib — DRUG
    Given PO
  • Positron Emission Tomography — PROCEDURE
    Undergo PET
  • Tuvusertib — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Jun 7, 2024
Status verified
May 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
66 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (peposertib, tuvusertib)
    Patients receive peposertib PO QD or BID daily on days 2-14 of cycle 1 and days 1-14 of subsequent cycles in combination with tuvusertib PO QD 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, blood sample collection, PET, CT, and MRI throughout the study.

Primary Outcome Measure

Incidence of dose limiting toxicity [ Time Frame: Up to 28 days ]

Locations (6)

FacilityCityStateZIPSite coordinators
National Cancer Institute Developmental Therapeutics ClinicBethesdaMaryland20892
Site Public Contact
800-411-1222
A P. Chen (PRINCIPAL_INVESTIGATOR)
National Institutes of Health Clinical CenterBethesdaMaryland20892-
Dana-Farber Cancer InstituteBostonMassachusetts02215
Site Public Contact
877-442-3324
Candace L. Haddox (PRINCIPAL_INVESTIGATOR)
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114
Site Public Contact
877-726-5130
Gregory M. Cote (PRINCIPAL_INVESTIGATOR)
NYU Langone Hospital - Long IslandMineolaNew York11501
Site Public Contact
[email protected]
212-263-4432
Nancy Chan (PRINCIPAL_INVESTIGATOR)
Laura and Isaac Perlmutter Cancer Center at NYU LangoneNew YorkNew York10016
Site Public Contact
[email protected]
Nancy Chan (PRINCIPAL_INVESTIGATOR)

Find similar trials in Bethesda, MD

By research site
National Cancer Institute Developmental Therapeutics Clinic· Bethesda, MDNational Institutes of Health Clinical Center· Bethesda, MDDana-Farber Cancer Institute· Boston, MAMassachusetts General Hospital Cancer Center· Boston, MANYU Langone Hospital - Long Island· Mineola, NYLaura and Isaac Perlmutter Cancer Center at NYU Langone· New York, NY

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