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.