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.
Signed informed consent.
Male or female aged ≥18 years.
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
Advanced or metastatic solid tumor, which is refractory to standard therapies, or for which no standard therapies exist.
Subjects who are pregnant.
Subjects with Myelodysplastic syndrome (MDS)/Acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
Have ongoing interstitial lung disease or pneumonitis.
Have any major gastrointestinal issues that could impact absorption of DAT-1604.
Sequential
DAT-1604 tablet
DrugDAT-1604, a potent and selective oral small molecule inhibitor of DNA Polymerase θ (Pol θ).
PART 1: Safety and Tolerability
To characterize the safety and tolerability of DAT-1604 monotherapy by evaluating the number of participants with dose limiting toxicities, adverse events, and laboratory abnormalities as graded by NCI CTCAE version 5.0
PART 2: RP2D
Recommended Phase 2 dose(RP2D) will be definite by safety monitoring committee(SMC).
ORR
Objective Response Rate (ORR) is defined as the proportion of patients that respond either partially or fully to therapy according to RECIST 1.1 criteria based on the CT-Scan.
DCR
Disease control rate (DCR) is defined as the percentage of patients who have achieved CR, PR, Non-CR/Non- PD, or SD in the study.
DOR
Duration of Response (DOR) is defined as the time from the earliest date of documented CR or PR until documented disease progression or death (by any cause, in the absence of progression) as determined by the Investigators using RECIST 1.1.
PFS
Progression-free survival (PFS) is defined as the time from the date of first dose of study drug to the first observation of documented disease progression per RECIST 1.1 as determined by the Investigators or death due to any cause, whichever occurs first.
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