DualityBio Inc.
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1310 in subjects with advanced solid tumors.
This is a multicenter, open-label, multiple-dose, FIH Phase 1/2a study. Phase 1 adopts the standard "3+3" design to identify: the MTD and/or RP2D of DB-1310 as monotherapy, the RCD\_A of DB-1310 in combination with trastuzumab or approved trastuzumab biosimilar and the RCD\_B of DB-1310 in combination with Osimertinib; Phase 2a is a dose expansion phase to confirm the safety, tolerability and explore efficacy in selected malignant solid tumors treated with DB-1310 as monotherapy or in combination with trastuzumab or approved trastuzumab biosimilar or in combination with Osimertinib, or in comb…
Inclusion Criteria 1. Male or female adults (defined as ≥ 18 years of age or acceptable age according to local regulations at the time of voluntarily signing of informed consent). 2. Have relapsed or progressed on or after standard systemic treatments, or intolerable with standard treatment, or for which no standard treatment is available. Documented radiological disease progression during/after most recent treatment regimen for advanced/unresectable, or metastatic disease. 3. At least one measurable lesion as assessed by the investigator according to response evaluation criteria in solid tum…
Administered I.V.
Administered I.V.
Oral
Oral