DM5167 for advanced breast cancer and other 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
This Phase 1 trial will try DM5167, a PARP‑1 selective medicine, in adults with advanced breast cancer or other advanced solid tumors (with BRCA1/2 mutations) to see if it is safe and better tolerated than older PARP inhibitors.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 58 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Digmbio Industry-sponsored |
| Locations | 4 sites (Gyeonggi-do and 3 other locations) |
| Trial ID | NCT07101601 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 19 or older with unresectable advanced solid tumors (including advanced breast cancer) who have BRCA1/2 mutations, measurable disease, ECOG ≤1, and adequate liver, kidney, and blood function are ideal candidates.
Not a fit: Patients without BRCA1/2 mutations, with poor performance status, significant uncontrolled comorbidities, prolonged QT interval, or unresolved toxicities from prior cancer therapy are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, DM5167 could offer effective tumor control with fewer blood‑related side effects compared with first‑generation PARP inhibitors.
How similar studies have performed: Earlier PARP inhibitors (e.g., olaparib, talazoparib) have shown benefit in BRCA‑mutant breast cancer, but PARP‑1 selective, second‑generation agents like DM5167 are newer and have limited clinical outcome data so far.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Gyeonggi-do and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.