RecruitingPhase 1NCT07101601

Study of DM5167 in Patients With Advanced Solid Tumors

An Open-label, Dose-finding, Phase 1 Study to Assess the Safety, Tolerability, Efficacy, and Pharmacokinetic Profile, and to Explore the Pharmacodynamic Profile of DM5167 in Patients With Advanced Solid Tumors


Sponsor

DIGMBIO

Enrollment

58 participants

Start Date

Oct 24, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

DM5167 is a second-generation of PARP inhibitor that selectively targets the PARP-1 enzyme. This results in less haematological toxicity and a high level of safety. The aim of the study is to assess the safety and tolerability of DM5167 in patients with advanced solid tumors not respond to other treatments.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing the safety and dosing of a new drug called DM5167 in people with advanced solid tumors that carry BRCA1 or BRCA2 gene mutations. **You may be eligible if...** - You are 19 years or older - You have advanced cancer (a solid tumor) that cannot be surgically removed - Your cancer has been confirmed to have a BRCA1 or BRCA2 mutation - You have at least one measurable tumor on scans - Your heart, liver, kidney, and blood counts are in acceptable range - You are in generally good functional health **You may NOT be eligible if...** - You have certain serious heart conditions (prolonged QT interval) - You have not recovered from significant side effects of previous treatments - You have other major health conditions that could interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDM5167

Once daily for 28 days


Locations(4)

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT07101601


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