A PARG Inhibitor DAT-2645 Monotherapy in Patients with Advanced/Metastatic Solid Tumors Harboring BRCA1/2 Loss of Function Alterations And/or Other Defects in the DDR Pathway

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

112

Participants

Timeline

Start Date

November 1, 2024

Primary Completion Date

November 1, 2026

Study Completion Date

June 1, 2027

Conditions
Solid CancersBRCA MutationHRD CancerBreast CancerProstate CancerColorectal CancerPancreatic CancerEndometrial CancerGastric CancerAdvanced CancerMetastatic Solid Tumors
Interventions
DRUG

DAT-2645 tablet

The patient will be randomized into 2 groups and take DAT-2645 tablet daily. dosage is optimal dose-1 or optimal dose-2, 21day/ Cycle. The subject of this part is to optimize dosage and definite RP2D.

DRUG

DAT-2645 tablet

The study set 6 dose level cohorts in dose escalation part.On C0D1, patient take DAT-2645 one time (Single use), The dosage is same as his enrolled cohort dose level. if no DLT, 7 days later(C1D1), patients will continue taking DAT-2645 tablet daily, dasage is same as before, 21days/cycle.

Trial Locations (2)

100021

Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijjing

100048

Peking University Cancer Hospital and Institute, Beijing

All Listed Sponsors
lead

Danatlas Pharmaceuticals Co., Ltd

INDUSTRY

NCT06614751 - A PARG Inhibitor DAT-2645 Monotherapy in Patients with Advanced/Metastatic Solid Tumors Harboring BRCA1/2 Loss of Function Alterations And/or Other Defects in the DDR Pathway | Biotech Hunter | Biotech Hunter