Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07101601

Study of DM5167 in Patients With Advanced Solid Tumors

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Advanced Breast Cancer

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Bundang Hospital, Gyeonggi-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

DM5167

Drug

Once daily for 28 days

Primary outcomes

  1. Part 1: Incidence of dose limiting toxicities (DLT) of DM5167

    Time frame: During the first cycle (28 days) of DM5167 treatment

    Determined by National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) version 5.0

  2. Part 1 and Part 2: Treatment emergent adverse events (TEAE) and serious adverse events (SAEs)

    Time frame: First dose up to 28 days post end of treatment

    Clinically significant changes in vital signs, physical examination, ECG and clinical laboratory tests graded by NCI CTCAE v5.0

Secondary outcomes

  1. Area Under Curve (AUC) of DM5167

    Time frame: - Cycle 1 - Day 1 & Day 15: pre-dose (0h) and up to 24 h post administration of DM5167 - Cycle 3, 5, 7 - Day 1: pre-dose

    AUC from the time of dosing to the time of the last measurable concentration

  2. Objective response rate (ORR)

    Time frame: Through study completion, an average of 1 year

    The proportion of subjects with best overall response (BOR) evaluated by RECIST version 1.1

  3. Maximum Concentration (Cmax) of DM5167

    Time frame: - Cycle 1 - Day 1 & Day 15: pre-dose (0h) and up to 24 h post administration of DM5167 - Cycle 3, 5, 7 - Day 1: pre-dose

    Maximum observed concentration after administration

Other outcomes

  1. PARP inhibition in blood

    Time frame: Cycle 1, 2, 3, 5, 7 - Day 1: before the administration of DM5167

    Change in poly (ADP-ribose) (PAR) levels in peripheral blood mononuclear cells (PBMCs))

Study contacts

Contact information is provided by the study sponsor or research team.

MyungEun Jung

CONTACT

[email protected]

+82 31 757 220

Sponsors and collaborators

Lead sponsor

DIGMBIO

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 3, 2025
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.