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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

Advanced Breast Cancer

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

Inclusion Criteria8

  • Men and women aged 19 years or older as of the date of written informed consent
  • Patients who have at least one measurable lesion according to RECIST version 1.1
  • ECOG performance status ≤ 1
  • Patients with life expectancy ≥ 12 weeks
  • Patients who meet the clinical laboratory test criteria confirming adequate liver, renal, and hematologic function
  • Patients who voluntarily provide written informed consent to participate in this study
  • Patients with histologically or cytologically confirmed unresectable advanced solid tumors
  • Patients who have BRCA1/BRCA2 mutations

Exclusion Criteria6

  • Patients with a medical history of significant illness
  • Patients with QT interval of \> 450 ms (for men) or \> 460 ms (for women)\\
  • Patients who have not yet recovered from toxicity related to previous anticancer therapy
  • Patients were predicted to demonstrate hypersensitivity to the components of the investigational medicinal product
  • Patients who have participated in another clinical trial and received an investigational product or medical device
  • Other individuals deemed inappropriate for participation in the study by the investigator

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

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NCT07101601

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