Study of DM5167 in Patients With Advanced Solid Tumors

DIGMBIO

Status and phase: Enrolling; Phase 1

Conditions: Advanced Breast Cancer

Treatments: Drug: DM5167

Study type: Interventional

Funder types: Industry

Identifiers

NCT07101601

DM001-101

Details and patient eligibility

About

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.

Enrollment: 58 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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58 participants in 7 patient groups

Part 1: Dose-escalation Cohort 1

Experimental group

Description:

The first level of dose of DM5167

Treatment:

Drug: DM5167

Part 1: Dose-escalation Cohort 2

Experimental group

Description:

The second level of dose of DM5167

Treatment:

Drug: DM5167

Part 1: Dose-escalation Cohort 3

Experimental group

Description:

The third level of dose of DM5167

Treatment:

Drug: DM5167

Part 1: Dose-escalation Cohort 4

Experimental group

Description:

The fourth level of dose of DM5167

Treatment:

Drug: DM5167

Part 1: Dose-escalation Cohort 5

Experimental group

Description:

The fifth level of dose of DM5167

Treatment:

Drug: DM5167

Part 1: Dose-escalation Cohort 6

Experimental group

Description:

The sixth level of dose of DM5167

Treatment:

Drug: DM5167

Part 2: Dose-expansion Cohort

Experimental group

Description:

The recommended Phase 2 dose of DM5167

Treatment:

Drug: DM5167