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Clinical Trials in South Korea / NCT07101601
Recruiting Phase 1

Study of DM5167 in Patients With Advanced Solid Tumors

NCT07101601 · tracked via the Priya Life Science South Korea tracker
Sponsor
DIGMBIO
Phase
Phase 1
Started
2024-10-24
Last updated
2025-08-03

Condition(s) studied

Advanced Breast Cancer

Investigational drug(s) / intervention(s)

DM5167

DM5167: Once daily for 28 days

Study 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

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Part 1: Incidence of dose limiting toxicities (DLT) of DM5167 — During the first cycle (28 days) of DM5167 treatment
    Determined by National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) version 5.0
  • Part 1 and Part 2: Treatment emergent adverse events (TEAE) and serious adverse events (SAEs) — 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

Trial sites (4)

FacilityCityRegionStatus
Seoul National University Bundang Hospital Gyeonggi-do South Korea Recruiting
Samsung Medical Center Seoul South Korea Recruiting
Seoul National University Hospital Seoul South Korea Recruiting
Severance Hospital Seoul South Korea Recruiting

Other trials for the same condition

Eribulin With or Without Trastuzumab-biosimilar in Patients With HER2-overexpressed Recurrent or Stage IV Breast Cancer Recruiting
Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer Recruiting
OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer Active, not recruiting
BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors Recruiting
A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07101601 on ClinicalTrials.gov ↗ ← All trials in South Korea