Advanced Breast CancerPhase 1NCT07101601
Study of DM5167 in Patients With Advanced Solid Tumors
A Phase 1 study testing DM5167 in people with Advanced Breast Cancer, run by DIGMBIO at 4 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- DM5167
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 24 Oct 2024to 31 Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea4 sites, 4 recruiting
- Recruiting
Seoul National University Bundang Hospital
Gyeonggi-do
Jee-Hyun Kim, jhkimmd@snu.ac.kr
Jee-Hyun Kim
- Recruiting
Samsung Medical Center
Seoul
Yeon Hee Park, yeonh.park@samsung.com
Yeon Hee Park
- Recruiting
Seoul National University Hospital
Seoul
Seock-Ah Im, moisa@snu.ac.kr
Seock-Ah Im
- Recruiting
Severance Hospital
Seoul
Gun Min Kim, GMKIM77@yuhs.ac
Gun Min Kim
About this study
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
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.
- Conditions
- Advanced Breast Cancer
- Being tested
- DM5167
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DM5167Drug
Once daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose-escalation Cohort 1 | Experimental | The first level of dose of DM5167 Receives: Drug: DM5167 |
| Part 1: Dose-escalation Cohort 2 | Experimental | The second level of dose of DM5167 Receives: Drug: DM5167 |
| Part 1: Dose-escalation Cohort 3 | Experimental | The third level of dose of DM5167 Receives: Drug: DM5167 |
| Part 1: Dose-escalation Cohort 4 | Experimental | The fourth level of dose of DM5167 Receives: Drug: DM5167 |
| Part 1: Dose-escalation Cohort 5 | Experimental | The fifth level of dose of DM5167 Receives: Drug: DM5167 |
| Part 1: Dose-escalation Cohort 6 | Experimental | The sixth level of dose of DM5167 Receives: Drug: DM5167 |
| Part 2: Dose-expansion Cohort | Experimental | The recommended Phase 2 dose of DM5167 Receives: Drug: DM5167 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Incidence of dose limiting toxicities (DLT) of DM5167
Determined by National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) version 5.0
Measured: During the first cycle (28 days) of DM5167 treatment
Part 1 and Part 2: Treatment emergent adverse events (TEAE) and serious adverse events (SAEs)
Clinically significant changes in vital signs, physical examination, ECG and clinical laboratory tests graded by NCI CTCAE v5.0
Measured: First dose up to 28 days post end of treatment
Secondary outcomes (3)
Area Under Curve (AUC) of DM5167
AUC from the time of dosing to the time of the last measurable concentration
Measured: - 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)
The proportion of subjects with best overall response (BOR) evaluated by RECIST version 1.1
Measured: Through study completion, an average of 1 year
Maximum Concentration (Cmax) of DM5167
Maximum observed concentration after administration
Measured: - 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start24 Oct 2024
- Primary completion30 Oct 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DIGMBIO
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101601
- Sponsor's protocol ID
- DM001-101
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to concerns regarding patient privacy, confidentiality, and compliance with applicable data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07101601
- Acronym / sponsor ID
- DM001-101
- Conditions
- Advanced Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- DIGMBIOIndustry (pharma, biotech, devices)
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose-escalation Cohort 1 | Experimental | Drug: DM5167The first level of dose of DM5167 |
| Part 1: Dose-escalation Cohort 2 | Experimental | Drug: DM5167The second level of dose of DM5167 |
| Part 1: Dose-escalation Cohort 3 | Experimental | Drug: DM5167The third level of dose of DM5167 |
| Part 1: Dose-escalation Cohort 4 | Experimental | Drug: DM5167The fourth level of dose of DM5167 |
| Part 1: Dose-escalation Cohort 5 | Experimental | Drug: DM5167The fifth level of dose of DM5167 |
| Part 1: Dose-escalation Cohort 6 | Experimental | Drug: DM5167The sixth level of dose of DM5167 |
| Part 2: Dose-expansion Cohort | Experimental | Drug: DM5167The recommended Phase 2 dose of DM5167 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DM5167Once daily for 28 days | Drug | Part 1: Dose-escalation Cohort 1, Part 1: Dose-escalation Cohort 2, Part 1: Dose-escalation Cohort 3, Part 1: Dose-escalation Cohort 4, Part 1: Dose-escalation Cohort 5, Part 1: Dose-escalation Cohort 6, Part 2: Dose-expansion Cohort |
Primary outcome
Part 1: Incidence of dose limiting toxicities (DLT) of DM5167
Time frame: During the first cycle (28 days) of DM5167 treatment
Determined by National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) version 5.0
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
Clinically significant changes in vital signs, physical examination, ECG and clinical laboratory tests graded by NCI CTCAE v5.0
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to concerns regarding patient privacy, confidentiality, and compliance with applicable data protection regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DM5167 in people with Advanced Breast Cancer, run by DIGMBIO at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MyungEun Jung (+82 31 757 220, myungeun@digmbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Incidence of dose limiting toxicities (DLT) of DM5167 (time frame: During the first cycle (28 days) of DM5167 treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.