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NCT02718066 · ClinicalTrials.gov registry record · Phase 1
Study of HBI-8000 With Nivolumab in Melanoma, Renal Cell Carcinoma and Non-Small Cell Lung Cancer
A Phase 1 study, sponsored by HUYABIO International.
- Completed
- Registry status
- Phase 1
- Development phase
- 96
- Enrollment target
NCT02718066: Completed Phase 1 study, sponsored by HUYABIO International.
NCT02718066 is a Phase 1 study that has completed, run by HUYABIO International. The registered enrollment target is 96 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02718066, a Phase 1 study, has completed, sponsored by HUYABIO International.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 96 participants
- Enrollment target
Study 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) Exploratory: * To investigate the kinetics and extent of histone acetylation in peripheral blood mononuclear cells (PBMC) at the RP2D of HBI-8000 (Phase 2 only) * To explore potential biomarkers for disease response through sequential sampling of blood and/or tumor tissue in subjects consenting to correlative sub-studies at participating sites (Phase 2 only) Dose Escalation (Phase 1b) will include up to 18 subjects, followed by Cohort Expansion (Phase 2) including up to 100 subjects (melanoma up to 60 subjects and NSCLC up to 40 subjects at MTD and/or RP2D.
Primary Outcome
The dose escalation schema of HBI 8000 followed the conventional 3+3 design. The starting dose was HBI 8000 20 mg twice a week. Dose escalation to 30 mg or 40 mg was determined by observation of DLT. At each dose level, a minimum of 3 subjects evaluable for DLT were enrolled. If 0 of the initial 3, or no more than 1 in a total 6 subjects experienced DLT, escalation to the next higher dose was allowed.
Interventions
- DRUG HBI-8000 in combination with nivolumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2016-08 |
| Est. Completion | 2023-09 |
| Phase | Phase 1 |
What the finished NCT02718066 record still lists
NCT02718066 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% higher).
The record links to 0 conditions, and to 1 intervention - of which HBI-8000 in combination with nivolumab is the first listed.
NCT02718066 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02718066 about?
NCT02718066 is a clinical study titled "Study of HBI-8000 With Nivolumab in Melanoma, Renal Cell Carcinoma and Non-Small Cell Lung Cancer". 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 tolerabi...
What is the current status of trial NCT02718066?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 96 participants. The study started on 2016-08. Estimated completion is 2023-09.
What interventions are being tested in trial NCT02718066?
The interventions under investigation include: HBI-8000 in combination with nivolumab (DRUG).
Who is sponsoring clinical trial NCT02718066?
This trial is sponsored by HUYABIO International, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02718066's enrollment target sits among peer trials
96 600th of 2000 higher than 1,391 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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