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OncoMatch/Clinical Trials/NCT05687136

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

Is NCT05687136 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies multiple treatments including Peposertib and Tuvusertib for advanced malignant solid neoplasm.

Phase 1RecruitingNational Cancer Institute (NCI)NCT05687136Data as of Sep 2026

Treatment: Peposertib · TuvusertibThis 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.

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Extracted eligibility criteria

Treatments studied

Other

PeposertibTuvusertib

Cancer type

Tumor Agnostic

Biomarker criteria

Required: ATM inactivating mutation

inactivating ATM mutations

Required: MYC amplification

MYC amplification

Required: FBXW7 mutation

mutation of FBXW7

Required: CCNE1 amplification

CCNE1 amplification

Required: ARID1A mutation

SWI/SNF member mutation (ARID1A, PBRM1, SMARCA4, ARID2, ARID1b, SMARCB1, SMARCA2, SS18)

Required: PBRM1 mutation

SWI/SNF member mutation (ARID1A, PBRM1, SMARCA4, ARID2, ARID1b, SMARCB1, SMARCA2, SS18)

Required: SMARCA4 mutation

SWI/SNF member mutation (ARID1A, PBRM1, SMARCA4, ARID2, ARID1b, SMARCB1, SMARCA2, SS18)

Required: ARID2 mutation

SWI/SNF member mutation (ARID1A, PBRM1, SMARCA4, ARID2, ARID1b, SMARCB1, SMARCA2, SS18)

Required: ARID1B mutation

SWI/SNF member mutation (ARID1A, PBRM1, SMARCA4, ARID2, ARID1b, SMARCB1, SMARCA2, SS18)

Required: SMARCB1 mutation

SWI/SNF member mutation (ARID1A, PBRM1, SMARCA4, ARID2, ARID1b, SMARCB1, SMARCA2, SS18)

Required: SMARCA2 mutation

SWI/SNF member mutation (ARID1A, PBRM1, SMARCA4, ARID2, ARID1b, SMARCB1, SMARCA2, SS18)

Required: SS18 mutation

SWI/SNF member mutation (ARID1A, PBRM1, SMARCA4, ARID2, ARID1b, SMARCB1, SMARCA2, SS18)

Required: ATRX mutation

mutation or loss of expression of ATRX/DAXX

Required: ATRX loss

mutation or loss of expression of ATRX/DAXX

Required: DAXX mutation

mutation or loss of expression of ATRX/DAXX

Required: DAXX loss

mutation or loss of expression of ATRX/DAXX

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: standard therapy

Progression on at least one prior standard therapy (if no standard therapy exists, the patient may be allowed if the treating investigator deems appropriate).

Lab requirements

Blood counts

Hemoglobin >= 9 g/dL; Absolute neutrophil count >= 1,500/mcL; Platelets >= 100,000/mcL

Kidney function

Glomerular filtration rate (GFR) >= 60 mL/min/1.73m^2

Liver function

Total bilirubin <= 1.5 x institutional ULN; AST/ALT <= 3x ULN or <= 5x ULN if liver metastases are present

Cardiac function

QTcF (using the Fridericia correction calculation) of < 470 msec; NYHA class 2B or better

Hemoglobin >= 9 g/dL. Absolute neutrophil count >= 1,500/mcL. Platelets >= 100,000/mcL. Total bilirubin <= 1.5 x institutional ULN. AST/ALT <= 3x ULN or <= 5x ULN if liver metastases are present. Glomerular filtration rate (GFR) >= 60 mL/min/1.73m^2. QTcF (using the Fridericia correction calculation) of >= 470 msec. NYHA class 2B or better.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • National Cancer Institute Developmental Therapeutics Clinic · Bethesda, Maryland
  • National Institutes of Health Clinical Center · Bethesda, Maryland
  • Massachusetts General Hospital Cancer Center · Boston, Massachusetts
  • Dana-Farber Cancer Institute · Boston, Massachusetts
  • NYU Langone Hospital - Long Island · Mineola, New York

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT05687136 currently recruiting?

Yes, this trial is currently recruiting patients.

Is prior treatment required for enrollment?

Yes. Patients must have previously received standard therapy.

Does this trial require ATM?

Yes, ATM inactivating mutation is a required biomarker for enrollment.

Does this trial require MYC?

Yes, MYC amplification is a required biomarker for enrollment.

Does this trial require FBXW7?

Yes, FBXW7 mutation is a required biomarker for enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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