A Phase 1/2, Open-Label, Dose-Escalation and Cohort-Expansion Study Evaluating the Safety, Pharmacokinetics, and Therapeutic Activity of OBI-902 in Participants With Advanced Solid Tumors
Summary
This is a 3-part study. Phase 1a (dose escalation) is designed to assess the safety and tolerability and to determine the maximum tolerated dose (MTD) and putative recommended phase 2 dose (RP2D) of study drug as monotherapy. Phase 1b (Cohort Expansion) is intended to further characterize the safety and preliminary antitumor activity of the putative RP2D of OBI-902 in selected tumor types. Phase 2 (Randomized Dose Optimization Cohorts) is intended to determine the optimal RP2D of OBI-902 in selected tumor types, before advancing to larger Phase 3 trials.
Arms & interventions
- DrugOBI-902
OBI-902 is an antibody-drug conjugate study drug
Outcome measures
Primary
Safety and tolerability of OBI-902: incidence of adverse events (AEs) and serious adverse events (SAEs), changes in selected clinical laboratory parameters, cardiac parameters, and vital signs.
To assess the safety and tolerability of OBI-902 when administered intravenously to participants with advanced solid tumors
Time frame: Duration of study, up to 54 weeks
Maximum tolerated dose (MTD) of OBI-902
To determine the MTD of OBI-902 at which the pre-defined rate of dose limiting toxicities (DLTs) is not exceeded.
Time frame: Duration of study, up to 54 weeks
Preliminary antitumor activity of OBI-902 in selected tumor types - Objective Response Rate (ORR)
Percentage of participants with ORR according to RECIST version 1.1 for each cohort
Time frame: Duration of study, up to 54 weeks
Preliminary antitumor activity of OBI-902 in selected tumor types - Duration of Response (DoR)
Percentage of participants with DOR according to RECIST version 1.1 for each cohort
Time frame: Duration of study, up to 54 weeks
Preliminary antitumor activity of OBI-902 in selected tumor types - Clinical Benefit Rate (CBR)
Percentage of participants with CBR according to RECIST version 1.1 for each cohort
Time frame: Duration of study, up to 54 weeks
Preliminary antitumor activity of OBI-902 in selected tumor types - Disease Control Rate (DCR)
Percentage of participants with DCR according to RECIST version 1.1 for each cohort
Time frame: Duration of study, up to 54 weeks
Safety and tolerability of OBI-902 in Phase 1b/Phase 2: incidence of AEs, SAEs, and laboratory abnormalities.
To further characterize safety and tolerability of OBI-902 as graded by NCI CTCAE version 5.0.
Time frame: Duration of study, up to 54 weeks
Optimal recommended phase 2 dose (RP2D) of OBI-902
To determine the optimal RP2D of OBI-902 for larger Phase 3 trials
Time frame: Duration of study, up to 54 weeks
Secondary
Preliminary long-term efficacy of OBI-902 in selected tumor types
Time frame: Duration of study, up to 54 weeks
Pharmacokinetics (PK) of OBI-902 and exatecan: Peak Plasma Concentration (Cmax)
Time frame: Duration of study, up to 54 weeks
Pharmacokinetics (PK) of OBI-902 and exatecan: area under the concentration-time curve (AUC)
Time frame: Duration of study, up to 54 weeks
Pharmacokinetics (PK) of OBI-902 and exatecan: half-life (T1/2)
Time frame: Duration of study, up to 54 weeks
Pharmacokinetics (PK) of OBI-902 and exatecan: clearance (CL)
Time frame: Duration of study, up to 54 weeks
Pharmacokinetics (PK) of OBI-902 and exatecan: volume distribution at steady state (Vdss)
Time frame: Duration of study, up to 54 weeks
Immunogenicity of OBI-902
Time frame: Duration of study, up to 54 weeks
Eligibility criteria
Study locations (3)
Scripps Green Hospital
La Jolla, California, 92037
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
NEXT Oncology
San Antonio, Texas, 78229