EICHOR
● Completed
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 · Sponsor: HUYABIO International, LLC.
About this study
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 t…
This description comes directly from the study's public registry record.
Talk to the study team
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
Locations (6)
| [Site 02] Mayo Clinic Arizona | Phoenix, Arizona, United States | — |
| [Site 11] University of California, San Diego Medical Center | La Jolla, California, United States | — |
| [Site 01] Hematology - Oncology Associates of the Treasure Coast | Port Saint Lucie, Florida, United States | — |
| [Site 09] H. Lee Moffitt Cancer Center and Research Institute, Inc. | Tampa, Florida, United States | — |
| [Site 13] Frederick Memorial Hospital d/b/a James M Stockman Cancer Institute | Frederick, Maryland, United States | — |
| [Site 12] University of Texas M.D. Anderson Cancer Center - Investigational Cancer Therapeutics | Houston, Texas, United States | — |
Follow this study
Save your interest here for when the public record changes — results posted, or the study's status changes. Email alerts for this study aren't switched on yet.
We keep this only about this public record, and never email you without alerts being switched on. Want it removed at any time? Email hello@eichor.com. Never medical advice. By subscribing you agree to our Terms of Use and Privacy Policy.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT02718066