NCT07101601 Study of DM5167 in Patients With Advanced Solid Tumors
| NCT ID | NCT07101601 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | DIGMBIO |
| Condition | Advanced Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 58 participants |
| Start Date | 2024-10-24 |
| Primary Completion | 2026-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 58 participants in total. It began in 2024-10-24 with a primary completion date of 2026-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07101601 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Advanced Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07101601 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07101601 currently recruiting?
Yes, NCT07101601 is actively recruiting participants. Contact the research team at myungeun@digmbio.com for enrollment information.
Where is the NCT07101601 trial being conducted?
This trial is being conducted at Gyeonggi-do, South Korea, Seoul, South Korea, Seoul, South Korea, Seoul, South Korea.
Who is sponsoring the NCT07101601 clinical trial?
NCT07101601 is sponsored by DIGMBIO. The trial plans to enroll 58 participants.
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