NCT06998173

Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of DAT-1604 in Advanced Solid Tumor

Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of DAT-1604 Tablets as Monotherapy in the Advanced Solid Tumor

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 228 (estimated)
• Sponsor: Danatlas Pharmaceuticals Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In Part 1, 6 dose cohorts will be set and defined maximum tolerated dose(MTD)/recommended dose for expansion (RDE). In Part 2, Food effects on pharmacokinetic of DAT-1604 will be assessed at RDE, and dose optimization will be conducted to definite recommended phase 2 dose (RP2D). Then , The RP2D expansion will be conducted in another 3 cohorts to evaluate the efficacy.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	DAT-1604 tablet	DAT-1604, a potent and selective oral small molecule inhibitor of DNA Polymerase θ (Pol θ).

Timeline

• Start date: 2025-07-31
• Primary completion: 2026-12-30
• Completion: 2028-07-30
• First posted: 2025-05-31
• Last updated: 2025-05-31

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study