Study of HBI-8000 With Nivolumab in Melanoma, Renal Cell Carcinoma and Non-Small Cell Lung Cancer
| Condition | Melanoma, Renal Cell Carcinoma, Non-Small Cell Lung Cancer |
|---|---|
| Phase | Phase 1/2 |
| Sponsor | HUYABIO International, LLC. |
| Status | Completed |
| Enrollment | 96 participants |
| Interventions | HBI-8000 in combination with nivolumab |
| Start date | Aug 18, 2016 |
| Completion date | Dec 12, 2023 |
| Results posted | Jul 30, 2026 |
Summary
A Phase 1b/2 Study to Assess the Safety and Efficacy of HBI-8000 in Combination with Nivolumab in Patients with Advanced Solid Tumors Including Melanoma, Renal Cell Carcinoma (RCC), and Non-Small Cell Lung Cancer (NSCLC). The primary objective of this study is: -To evaluate the safety and tolerability of HBI-8000 when combined with a standard dose and regimen of nivolumab, and to evaluate frequency and severity of toxicities of this combination treatment The secondary objectives of this study include: * To explore the efficacy of study treatment as measured by Objective Response Rate (ORR), Disease Control Rate (DCR), Clinical Benefit Rate (CBR), Duration of Response (DoR), Progression-Free Survival (PFS) in all subjects treated at RP2D * To obtain pharmacokinetics of twice weekly HBI-8000 when administered in combination with nivolumab administered once every two weeks (Phase 1b all sites) * To obtain pharmacokinetics of twice weekly HBI-8000 when administered in combination with nivolumab administered per package insert dose and administration (Phase 2 selected sites) * To characterize the effect of HBI-8000 on the electrocardiogram QT corrected (QTc) interval (Phase 1b only) Exp
Number of Patients Who Experienced at Least One DLT During the DLT Assessment Period for MTD Determination
| Phase 1b: HBI-8000 20 mg in Combination With Nivolumab | 0 patients |
|---|---|
| Phase 1b: HBI-8000 30 mg in Combination With Nivolumab | 0 patients |
| Phase 1b: HBI-8000 40 mg in Combination With Nivolumab | 2 patients |
Open in BENITIONS View on ClinicalTrials.gov
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