Trials / Active Not Recruiting
Active Not RecruitingNCT06480240
A Phase 1/2 Study of OBI-992 in Subjects 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-992 in Subjects With Advanced Solid Tumors
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 117 (estimated)
- Sponsor
- OBI Pharma, Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a 2-part trial: Part A (Dose Escalation) is designed to establish the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of OBI-992 (Anti-TROP2 antibody drug conjugate, anti-TROP2 monoclonal antibody-cleavable peptide linker-exatecan) as monotherapy. Part B (Cohort Expansion) is intended to further characterize the safety and preliminary clinical activity profile of the RP2D of OBI-992 in subjects with advanced solid tumors.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OBI-992 | OBI-992 is an antibody-drug conjugate |
Timeline
- Start date
- 2024-06-12
- Primary completion
- 2027-06-01
- Completion
- 2027-06-01
- First posted
- 2024-06-28
- Last updated
- 2025-08-08
Locations
8 sites across 2 countries: United States, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06480240. Inclusion in this directory is not an endorsement.