Actively Recruiting
A Study Evaluating OBI-902 in Participants With Advanced Solid Tumors
Led by OBI Pharma, Inc · Updated on 2026-01-05
147
Participants Needed
6
Research Sites
183 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study Evaluating OBI-902 in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants, 18 years of age or older at the time of consent
- Provide written informed consent prior to any study-related procedure
- Histologically or cytologically confirmed metastatic or advanced solid tumor not curable with local therapies
- Treated with standard-of-care therapy deemed ineffective or declined standard-of-care therapy with documentation
- Measurable disease per RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function including hepatic, renal, and hematologic parameters as specified
- Willing and able to comply with all protocol assessments, visits, and procedures including evaluable pretreatment tumor biopsy
- Females of childbearing potential must have negative pregnancy test and agree to use reliable contraception during treatment and 7 months after last dose
- Participants not of childbearing potential (permanently sterilized, postmenopausal) eligible
- Males must agree to use contraception during treatment and for 4 months after last dose
- Participants with HIV infection eligible if CD4+ T-cell counts ≥350 cells/µL and viral load <200 copies/mL, on stable ART for at least 4 weeks
- Participants with chronic HBV infection eligible if viral load below quantification limit with or without suppressive therapy
- Participants with history of HCV infection eligible if under curative antiviral treatment and viral load below quantification limit
- Phase 1b participants must have biliary tract cancer, gastric or gastroesophageal junction cancer, or platinum-resistant ovarian cancer
You will not qualify if you...
- Less than 3 weeks from prior cytotoxic chemotherapy or radiation therapy, and less than 5 half-lives or 3 weeks from prior biologic therapies before first dose
- Major surgery or significant traumatic injury within 28 days prior to first dose
- Sensory or motor neuropathy Grade 2 or greater
- History of solid organ transplant (corneal transplant without immunosuppressive therapy allowed)
- Unresolved toxicities from prior anticancer therapy above Grade 1 except alopecia and specified labs
- Prior therapy targeting TROP2 (Phase 2 only)
- Corrected QT interval (QTcF) prolongation >470 msec on screening ECG
- Known hypersensitivity to OBI-902 or its excipients
- Untreated central nervous system metastases; treated brain metastases eligible if stable for at least 4 weeks
- Significant clinical cardiac abnormality (e.g., heart failure, unstable angina)
- Life-threatening medical comorbidities or conditions affecting study compliance or interpretation
- Pregnant or breastfeeding
- Receiving any prohibited concurrent medications as listed in the protocol
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Scripps Green Hospital
La Jolla, California, United States, 92037
Actively Recruiting
2
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
3
NEXT Oncology
San Antonio, Texas, United States, 78229
Actively Recruiting
4
Wan Fan Hospital
Taipei, Wenshan, Taiwan, 116
Actively Recruiting
5
Shuang Ho Hospital
Taipei, Zhonghe, Taiwan, 23561
Active, Not Recruiting
6
China Medical University Hospital
Taichung, Taiwan, 404327
Actively Recruiting
Research Team
O
OBI Pharma, Inc. Sponsor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
11
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