A Phase 1/2 Study of OBI-992 in Subjects With Advanced Solid Tumors
NCT Number: NCT06480240
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Advanced Solid Tumor
Interventions: DRUG: OBI-992
Sponsor: OBI Pharma, Inc
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 117
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-12
Completion Date: 2027-06
Locations: NEXT Oncology Texas, San Antonio, Texas, 78229, United States|NEXT Oncology Virginia, Fairfax, Virginia, 22031, United States

Summary:
This is a 2-part trial: Part A (Dose Escalation) is designed to establish the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of OBI-992 (Anti-TROP2 antibody drug conjugate, anti-TROP2 monoclonal antibody-cleavable peptide linker-exatecan) as monotherapy. Part B (Cohort Expansion) is intended to further characterize the safety and preliminary clinical activity profile of the RP2D of OBI-992 in subjects with advanced solid tumors.

Primary Outcome Measures: Safety and tolerability of OBI-992: incidence of adverse events, serious adverse events, and laboratory abnormalities, To determine the safety and tolerability of OBI-992 when administered to subjects with advanced solid tumors, based on adverse events (AEs), serious adverse events (SAEs) and laboratory abnormalities graded by NCI CTCAE v5.0, Duration of study, up to 2 years and 2 months|Maximum tolerated dose and recommended Phase 2 dose of OBI-992, To determine the maximum tolerated dose (MTD) and optimal recommended phase 2 dose (RP2D) of OBI-992, Duration of study, up to 2 years and 2 months|Preliminary clinical activity profile - objective response rate (ORR), Percentage of subjects in the as-treated population with objective response according to response evaluation criteria in solid tumors (RECIST v.1.1), Duration of study, up to 2 years and 2 months|Preliminary clinical activity profile - clinical benefit rate (CBR), Percentage of subjects in the as-treated population with clinical benefit according to response evaluation criteria in solid tumors (RECIST v.1.1), Duration of study, up to 2 years and 2 months|Preliminary clinical activity profile - duration of response (DOR), Percentage of subjects in the as-treated population with response according to response evaluation criteria in solid tumors (RECIST v.1.1), Duration of study, up to 2 years and 2 months|Preliminary clinical activity profile - disease control rate (DCR), Percentage of subjects in the as-treated population with disease control according to response evaluation criteria in solid tumors (RECIST v.1.1), Duration of study, up to 2 years and 2 months|Preliminary clinical activity profile - progression-free survival, Percentage of subjects in the as-treated population with progression-free survival according to response evaluation criteria in solid tumors (RECIST v.1.1), Duration of study, up to 2 years and 2 months
Secondary Outcome Measures: Immunogenicity of OBI-992: anti-drug antibodies (ADAs), To evaluate the immunogenicity of OBI-992 (anti-drug antibodies), characterized by percentage of subjects with ADAs in blood, Duration of study, up to 2 years and 2 months|Serum pharmacokinetics (PK): Peak Plasma Concentration (Cmax) of OBI-992 and its active metabolite, To determine the serum Cmax of OBI-992 and its active metabolite exatecan, Duration of study, up to 2 years and 2 months|Serum pharmacokinetics (PK): area under the concentration-time curve (AUC) of OBI-992 and its active metabolite, To determine the serum AUC of OBI-992 and its active metabolite exatecan, Duration of study, up to 2 years and 2 months|Serum pharmacokinetics (PK): half-life (T1/2) of OBI-992 and its active metabolite, To determine the serum half-life of OBI-992 and its active metabolite exatecan, Duration of study, up to 2 years and 2 months|Serum pharmacokinetics (PK): clearance (CL) of OBI-992 and its active metabolite, To determine the serum clearance (CL) of OBI-992 and its active metabolite exatecan, Duration of study, up to 2 years and 2 months|Serum pharmacokinetics (PK): Volume distribution at steady state (Vdss) of OBI-992 and its active metabolite, To determine the serum volume distribution at steady state of OBI-992 and its active metabolite exatecan, Duration of study, up to 2 years and 2 months