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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 is a Phase 1 study that has completed, run by HUYABIO International. The registered enrollment target is 96 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02718066
The ClinicalTrials.gov registry entry for NCT02718066 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is HUYABIO International, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which HBI-8000 in combination with nivolumab is the first listed.
NCT02718066 reports 0 study locations.
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.
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