Study of DM5167 in Patients With Advanced Solid Tumors

NCT07101601 | Recruiting Phase 1

• 1 other identifier: DM001-101
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Advanced Breast Cancer

Outcome Measures

Primary Outcomes (2)

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

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

  During the first cycle (28 days) of DM5167 treatment

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

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

  First dose up to 28 days post end of treatment

Secondary Outcomes (3)

• Area Under Curve (AUC) of DM5167

  - 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

• Objective response rate (ORR)

  Through study completion, an average of 1 year

• Maximum Concentration (Cmax) of DM5167

  - 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

Other Outcomes (1)

• PARP inhibition in blood

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

Study Arms (7)

Part 1: Dose-escalation Cohort 1

EXPERIMENTAL

The first level of dose of DM5167

Drug: DM5167

Part 1: Dose-escalation Cohort 2

EXPERIMENTAL

The second level of dose of DM5167

Drug: DM5167

Part 1: Dose-escalation Cohort 3

EXPERIMENTAL

The third level of dose of DM5167

Drug: DM5167

Part 1: Dose-escalation Cohort 4

EXPERIMENTAL

The fourth level of dose of DM5167

Drug: DM5167

Part 1: Dose-escalation Cohort 5

EXPERIMENTAL

The fifth level of dose of DM5167

Drug: DM5167

Part 1: Dose-escalation Cohort 6

EXPERIMENTAL

The sixth level of dose of DM5167

Drug: DM5167

Part 2: Dose-expansion Cohort

EXPERIMENTAL

The recommended Phase 2 dose of DM5167

Drug: DM5167

Interventions

DM5167 DRUG

Once daily for 28 days

Part 1: Dose-escalation Cohort 1; Part 1: Dose-escalation Cohort 2; Part 1: Dose-escalation Cohort 3; Part 1: Dose-escalation Cohort 4; Part 1: Dose-escalation Cohort 5; Part 1: Dose-escalation Cohort 6; Part 2: Dose-expansion Cohort

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• DIGMBIO: lead

Study Sites (4)

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

Central Study Contacts

MyungEun Jung

CONTACT

+82 31 757 220; myungeun@digmbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: August 3, 2025
• Study Start: October 24, 2024
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (4)