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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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

Positron Emission Tomography

2008

Completed Phase 2

~2240

Peposertib

2021

Completed Phase 1

~20

Computed Tomography

2017

Completed Phase 2

~2720

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Biopsy

2014

Completed Phase 4

~1090

Biospecimen Collection

2004

Completed Phase 2

~1700

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,672 Previous Clinical Trials

40,926,375 Total Patients Enrolled

Gregory M CotePrincipal InvestigatorDana-Farber - Harvard Cancer Center LAO

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current vacancies for participants in this experiment?

"Affirmative. According to information published in clinicaltrials.gov, this medical trial - posted on November 27th 2023 and last updated on October 10th 2023 - is still actively seeking participants with 66 patients required from a single site."

Answered by AI

What is the upper limit of individuals engaged in this trial?

"Affirmative. Clinicaltrials.gov confirms that this experiment, initially published on November 27th 2023, is currently seeking out participants. 66 patients are expected to be enrolled from one medical site."

Answered by AI

Has the FDA sanctioned the use of peposertib and tuvusertib as treatments?

"As this trial is in its initial stages, meaning there are limited data surrounding both safety and efficacy, Treatment (peposertib, tuvusertib) was scored a 1 on our Power scale."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Testing the Combination of Two Anti-cancer Drugs, Peposertib (M3814) and M1774 for Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05687136.