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

NCT07124117 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: OBI-902-001
• Study Type: interventional
• Target: 147
• Locations: 2 countries
• Sites: 6

Brief 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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (8)

• 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

  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.

  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

  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

  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

  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

  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.

  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

  Duration of study, up to 54 weeks

Secondary Outcomes (7)

• Preliminary long-term efficacy of OBI-902 in selected tumor types

  Duration of study, up to 54 weeks

• Pharmacokinetics (PK) of OBI-902 and exatecan: Peak Plasma Concentration (Cmax)

  Duration of study, up to 54 weeks

• Pharmacokinetics (PK) of OBI-902 and exatecan: area under the concentration-time curve (AUC)

  Duration of study, up to 54 weeks

• Pharmacokinetics (PK) of OBI-902 and exatecan: half-life (T1/2)

  Duration of study, up to 54 weeks

• Pharmacokinetics (PK) of OBI-902 and exatecan: clearance (CL)

  Duration of study, up to 54 weeks

Study Arms (11)

Phase 1a Dose Escalation: Cohort 1

EXPERIMENTAL

OBI-902 at dose level 1.6 mg/kg, Q3W

Drug: OBI-902

Phase 1a Dose Escalation: Cohort 2

EXPERIMENTAL

OBI-902 at dose level 3.0 mg/kg, Q3W

Drug: OBI-902

Phase 1a Dose Escalation: Cohort 3

EXPERIMENTAL

OBI-902 at dose level 4.5 mg/kg, Q3W

Drug: OBI-902

Phase 1a Dose Escalation: Cohort 4

EXPERIMENTAL

OBI-902 at dose level 6.0 mg/kg, Q3W

Drug: OBI-902

Phase 1a Dose Escalation: Cohort 5

EXPERIMENTAL

OBI-902 at dose level 8.0 mg/kg, Q3W

Drug: OBI-902

Phase 1a Dose Escalation: Cohort 6

EXPERIMENTAL

OBI-902 at dose level 10.0 mg/kg, Q3W

Drug: OBI-902

Phase 1b Cohort Expansion: Cohort 1

EXPERIMENTAL

OBI-902 at the putative RP2D determined during the Phase 1a Dose Escalation; biliary tract cancer cohort.

Drug: OBI-902

Phase 1b Cohort Expansion: Cohort 2

EXPERIMENTAL

OBI-902 at the putative RP2D determined during the Phase 1a Dose Escalation; gastric and gastroesophageal cancer cohort.

Drug: OBI-902

Phase 1b Cohort Expansion: Cohort 3

EXPERIMENTAL

OBI-902 at the putative RP2D determined during the Phase 1a Dose Escalation; platinum resistant ovarian cancer cohort.

Drug: OBI-902

Phase 2 Randomized Dose Optimization Cohort: Cohort 1

EXPERIMENTAL

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.

Drug: OBI-902

Phase 2 Randomized Dose Optimization Cohort: Cohort 2

EXPERIMENTAL

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.

Drug: OBI-902

Interventions

OBI-902 DRUG

OBI-902 is an antibody-drug conjugate study drug

Phase 1a Dose Escalation: Cohort 1; Phase 1a Dose Escalation: Cohort 2; Phase 1a Dose Escalation: Cohort 3; Phase 1a Dose Escalation: Cohort 4; Phase 1a Dose Escalation: Cohort 5; Phase 1a Dose Escalation: Cohort 6; Phase 1b Cohort Expansion: Cohort 1; Phase 1b Cohort Expansion: Cohort 2; Phase 1b Cohort Expansion: Cohort 3; Phase 2 Randomized Dose Optimization Cohort: Cohort 1; Phase 2 Randomized Dose Optimization Cohort: Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants, 18 years of age or older at the time of consent
• Provide written informed consent prior to performing any study-related procedure
• Histologically or cytologically confirmed participants with metastatic or advanced solid tumor that is not curable with local therapies
• Participants must have been treated with established standard-of-care therapy, andphysicians have determined that such established therapy is not sufficiently efficacious, or patients have declined to receive standard-of-care therapy. In the latter case, the source documentation must state the effective therapies the participant is declining.
• Measurable disease (i.e., at least one measurable lesion per RECIST 1.1)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate organ function defined as:
• a. Hepatic:
• i. Serum ALT ≤3 × upper limit of normal (ULN), ≤5 × ULN in the presence of liver metastases
• i. Serum AST ≤3 × ULN, ≤5 × ULN in presence of liver metastases
• ii. Serum bilirubin ≤1.5 × ULN (unless due to Gilbert's syndrome (typically elevated total bilirubin of 1-5 mg/dL with a normal direct bilirubin) or hemolysis)
• b. Creatinine clearance \>60 mL/minute using Modification of Diet in Renal Disease equation
• c. Hematologic:
• i. ANC ≥1,500/µL (\>1,200/µL in Duffy antigen-null participants)
• ii. Platelets ≥100,000/µL

You may not qualify if:

• Less than 3 weeks from prior cytotoxic chemotherapy or radiation therapy; and less than 5 half-lives or 3 weeks, whichever is shorter, from prior biologic therapies, prior to the first dose of OBI-902.
• Participants that have undergone a major surgical procedure (as defined by the investigator) or significant traumatic injury within 28 days prior to the first dose of OBI-902.
• Sensory or motor neuropathy of Grade 2 or greater.
• Participants with a history of solid organ transplants. Corneal transplant without immunosuppressive therapy is allowed.
• Receipt of any prior therapy targeting TROP2. (Phase 2 only)
• Corrected QT interval (QTcF) prolongation to \>470 msec based on the average of the screening 12-lead ECGs
• Known hypersensitivity to OBI-902 or its excipients.
• Participants with known untreated central nervous system (CNS) metastases. Participants with treated brain metastases are eligible if there is no evidence of progression for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (magnetic resonance imaging \[MRI\] or computed tomography \[CT\]) during the screening period.
• Participants with significant clinical cardiac abnormality (e.g., clinical heart failure or unstable angina).
• Any medical comorbidity that is life-threatening or, in the opinion of the Investigator, renders the participant unsuitable for participation in a clinical trial due to possible noncompliance, would place the participant at an unacceptable risk and/or potential to affect interpretation of results of the study.
• Participants who are pregnant or breastfeeding.
• Is receiving any concurrent prohibited medications as listed in OBI-902-001 clinical protocol.

Sponsors & Collaborators

• OBI Pharma, Inc: lead

Study Sites (6)

Scripps Green Hospital

La Jolla, California, 92037, United States

RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

NEXT Oncology

San Antonio, Texas, 78229, United States

RECRUITING

Wan Fan Hospital

Taipei, Wenshan, 116, Taiwan

RECRUITING

Shuang Ho Hospital

Taipei, Zhonghe, 23561, Taiwan

ACTIVE NOT RECRUITING

China Medical University Hospital

Taichung, 404327, Taiwan

RECRUITING

Central Study Contacts

OBI Pharma, Inc. Sponsor

CONTACT

1-619-537-7821; clinicaltrials.gov-queries@obipharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 15, 2025
• Study Start: August 4, 2025
• Primary Completion (Estimated): February 8, 2029
• Study Completion (Estimated): February 8, 2029
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

TW (3); US (3)