A Study Evaluating OBI-902 in Participants With Advanced Solid Tumors

Part of paid clinical trials in La Jolla, California.

Sponsor
OBI Pharma, Inc
Study ID
NCT07124117
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • OBI-902 — DRUG
    OBI-902 is an antibody-drug conjugate study drug

Study Details

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.

Key Dates

Start date
Aug 4, 2025
Status verified
Dec 2025
Primary completion
Feb 8, 2029
Completion
Feb 8, 2029

Study Design

Enrollment
147 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1a Dose Escalation: Cohort 1
    OBI-902 at dose level 1.6 mg/kg, Q3W
  • Experimental: Phase 1a Dose Escalation: Cohort 2
    OBI-902 at dose level 3.0 mg/kg, Q3W
  • Experimental: Phase 1a Dose Escalation: Cohort 3
    OBI-902 at dose level 4.5 mg/kg, Q3W
  • Experimental: Phase 1a Dose Escalation: Cohort 4
    OBI-902 at dose level 6.0 mg/kg, Q3W
  • Experimental: Phase 1a Dose Escalation: Cohort 5
    OBI-902 at dose level 8.0 mg/kg, Q3W
  • Experimental: Phase 1a Dose Escalation: Cohort 6
    OBI-902 at dose level 10.0 mg/kg, Q3W
  • Experimental: Phase 1b Cohort Expansion: Cohort 1
    OBI-902 at the putative RP2D determined during the Phase 1a Dose Escalation; biliary tract cancer cohort.
  • Experimental: Phase 1b Cohort Expansion: Cohort 2
    OBI-902 at the putative RP2D determined during the Phase 1a Dose Escalation; gastric and gastroesophageal cancer cohort.
  • Experimental: Phase 1b Cohort Expansion: Cohort 3
    OBI-902 at the putative RP2D determined during the Phase 1a Dose Escalation; platinum resistant ovarian cancer cohort.
  • Experimental: Phase 2 Randomized Dose Optimization Cohort: Cohort 1
    Randomized dose optimization cohort. Tumor type and/or population will be based on safety/tolerability, PK, and preliminary efficacy of OBI-902 from Phase 1 part of the study.
  • Experimental: Phase 2 Randomized Dose Optimization Cohort: Cohort 2
    Randomized dose optimization cohort. Tumor type and/or population will be based on safety/tolerability, PK, and preliminary efficacy of OBI-902 from Phase 1 part of the study.

Primary Outcome Measure

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. [ Time Frame: Duration of study, up to 54 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Scripps Green HospitalLa JollaCalifornia92037
OBI Investigator Site (PRINCIPAL_INVESTIGATOR)
The University of Texas MD Anderson Cancer CenterHoustonTexas77030
OBI Investigator Site (PRINCIPAL_INVESTIGATOR)
NEXT OncologySan AntonioTexas78229
OBI Investigator Site (PRINCIPAL_INVESTIGATOR)

Find similar trials in La Jolla, CA

By research site
Scripps Green Hospital· La Jolla, CAThe University of Texas MD Anderson Cancer Center· Houston, TXNEXT Oncology· San Antonio, TX

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