drugset / Trial / NCT04084366
Phase 1/2 Study of OBI-999 in Patients With Advanced Solid Tumors
Non-randomizedSequentialOpen-labelTreatment
Summary
The purpose of this study is to establish the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of OBI-999 as monotherapy, and to characterize the safety and preliminary clinical activity profile of the RP2D of OBI-999 in patients with advanced solid tumors.
Timeline
- Start
- 2019-11-25
- Primary completion
- 2023-10-27
- Completion
- 2023-10-27
Outcome
Outcome not reported
Stopped (Enrollment): “Has not shown its expected therapeutic potential for the enrolled patients in this trial”
Publications
- Tsimberidou AM, Sigal D, Varghese A, Vaena D, Bai LY, Chen MH, Yeh CN, Yen CJ, Baysal MA, Chakraborty A, Lee I, Shia CS, Ristoski K, Xu D. Dose-Expansion Study of OBI-999, a Globo H-Targeting Antibody-Drug Conjugate, in Patients with Advanced Solid Tumors. Oncologist. 2026 Jun 29:oyag249. doi: 10.1093/oncolo/oyag249. Online ahead of print.
- Tsimberidou AM, Vo HH, Beck J, Shia CS, Hsu P, Pearce TE. First-in-Human Study of OBI-999, a Globo H-Targeting Antibody-Drug Conjugate, in Patients With Advanced Solid Tumors. JCO Precis Oncol. 2023 Jan;7:e2200496. doi: 10.1200/PO.22.00496.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | OBI-999 | Unknown | 0.4 mg/kg | Intravenous |
| Subject | OBI-999 | Unknown | 0.8 mg/kg | Intravenous |
| Subject | OBI-999 | Unknown | 1.2 mg/kg | Intravenous |
| Subject | OBI-999 | Unknown | 1.6 mg/kg | Intravenous |
| Subject | OBI-999 | Unknown | 2 mg/kg | Intravenous |
Indications
No indication recorded.