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A Study Evaluating OBI-902 in Participants With Advanced Solid Tumors | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

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

NCT07124117•OBI Pharma, Inc

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female participants, 18 years of age or older at the time of consent
•2. Provide written informed consent prior to performing any study-related procedure
•3. Histologically or cytologically confirmed participants with metastatic or advanced solid tumor that is not curable with local therapies
•4. 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.
•5. Measurable disease (i.e., at least one measurable lesion per RECIST 1.1)
•6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
•7. 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
+21 more criteria

Exclusion Criteria

•1. 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.
•2. 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.
•3. Sensory or motor neuropathy of Grade 2 or greater.
•4. Participants with a history of solid organ transplants. Corneal transplant without immunosuppressive therapy is allowed.

Locations (6)

Scripps Green Hospital

La Jolla, California, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

NEXT Oncology

San Antonio, Texas, United States

Wan Fan Hospital

Taipei, Wenshan, Taiwan

Shuang Ho Hospital

Taipei, Zhonghe, Taiwan

China Medical University Hospital

Taichung, Taiwan

Key Dates

Start Date

August 4, 2025

Primary Completion Date

February 8, 2029

Completion Date

February 8, 2029

Last Updated

January 5, 2026

Enrollment

147

ESTIMATED participants

Conditions

Advanced Solid Tumor

Interventions

OBI-902

DRUG

Contacts

OBI Pharma, Inc. Sponsor

CONTACT

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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