Study of DM5167 in Patients With Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DM5167.
- Who it may be relevant to
- Registry conditions: Advanced Breast Cancer. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug DM5167
Once daily for 28 days
Primary outcome measures
- Part 1: Incidence of dose limiting toxicities (DLT) of DM5167 [Time frame: During the first cycle (28 days) of DM5167 treatment]
- Part 1 and Part 2: Treatment emergent adverse events (TEAE) and serious adverse events (SAEs) [Time frame: First dose up to 28 days post end of treatment]
Secondary outcome measures (3)
- Area Under Curve (AUC) of DM5167 [Time frame: - 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) [Time frame: Through study completion, an average of 1 year]
- Maximum Concentration (Cmax) of DM5167 [Time frame: - 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 4 centers
- Seoul National University Bundang Hospital — Gyeonggi-do
- Samsung Medical Center — Seoul
- Seoul National University Hospital — Seoul
- Severance Hospital — Seoul
Identifiers
NCT: NCT07101601 · DM001-101