Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
58 participants
INTERVENTIONAL
2024-10-24
2027-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1: Dose-escalation Cohort 1
The first level of dose of DM5167
DM5167
Once daily for 28 days
Part 1: Dose-escalation Cohort 2
The second level of dose of DM5167
DM5167
Once daily for 28 days
Part 1: Dose-escalation Cohort 3
The third level of dose of DM5167
DM5167
Once daily for 28 days
Part 1: Dose-escalation Cohort 4
The fourth level of dose of DM5167
DM5167
Once daily for 28 days
Part 1: Dose-escalation Cohort 5
The fifth level of dose of DM5167
DM5167
Once daily for 28 days
Part 1: Dose-escalation Cohort 6
The sixth level of dose of DM5167
DM5167
Once daily for 28 days
Part 2: Dose-expansion Cohort
The recommended Phase 2 dose of DM5167
DM5167
Once daily for 28 days
Interventions
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DM5167
Once daily for 28 days
Eligibility Criteria
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Inclusion Criteria
* 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 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
19 Years
ALL
No
Sponsors
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DIGMBIO
INDUSTRY
Responsible Party
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Locations
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Seoul National University Bundang Hospital
Gyeonggi-do, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DM001-101
Identifier Type: -
Identifier Source: org_study_id
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