DM5167 for advanced breast cancer and other advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first‑in‑human Phase 1, open‑label trial testing ascending doses of DM5167 to define safety, tolerability, and a recommended dose in adults with unresectable advanced solid tumors and BRCA1/2 mutations. Participants must have measurable disease by RECIST v1.1, ECOG performance status 0–1, and adequate organ function. The study focuses on safety and hematologic toxicity given DM5167’s design as a PARP‑1 selective agent intended to reduce blood‑related side effects seen with earlier PARP inhibitors. Clinical sites in Seoul and Gyeonggi‑do will conduct dosing, safety monitoring, and tumor assessments.

Why it matters

Who can join: the full rules

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

Where it's running

• 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

Study contacts

• Study coordinator: MyungEun Jung
• Email: myungeun@digmbio.com
• Phone: +82 31 757 220

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.