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

First listed
Aug 15, 2025
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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