Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of DAT-1604 in Advanced Solid Tumor
NCT06998173 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 228
Last updated 2025-05-31
Summary
The primary objective of the study is to evaluate the safety, tolerability, PK, and preliminary efficacy of a Polθ Inhibitor DAT-1604 in patients with advanced/metastatic solid tumors, which is refractory to standard therapies, or for which no standard therapies exist.
Conditions
Interventions
- DRUG
-
DAT-1604 tablet
DAT-1604, a potent and selective oral small molecule inhibitor of DNA Polymerase θ (Pol θ).
Sponsors & Collaborators
-
Danatlas Pharmaceuticals Co., Ltd
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-31
- Primary Completion
- 2026-12-30
- Completion
- 2028-07-30
- FDA Drug
- Yes
Countries
- China
Study Locations
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