NCT07101601RecruitingPhase 1
Study of DM5167 in Patients With 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
Source: ClinicalTrials.gov · Last updated 3 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 58 (estimated)
- First submitted
- 21 Jul 2025
- Start date
- 24 Oct 2024
- Primary completion date
- 30 Oct 2026
- Lead sponsor
- DIGMBIO
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07101601
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 58
- From 24 Oct 2024 to the primary completion date, 30 Oct 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have not yet recovered from toxicity related to previous anticancer therapy
- Patients who have participated in another clinical trial and received an investigational product or medical device
Other illness
- Patients with a medical history of significant illness
- Patients were predicted to demonstrate hypersensitivity to the components of the investigational medicinal product
Lab values
- Patients with QT interval of \> 450 ms (for men) or \> 460 ms (for women)\\
Other
- Other individuals deemed inappropriate for participation in the study by the investigator
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Gyeonggi-do | South Korea | Recruiting |
| Severance hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.