Clinical Trials Search
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)
This study is being done to learn more about the safety and activity of a new investigational drug, HBI-8000, when combined with an approved drug, nivolumab, for treating cancer. An investigational drug is a drug that has not been approved for marketing to the general public by the Food and Drug Administration (FDA) but is allowed to be tested in people for research purposes.
Primary: - To evaluate the safety and tolerability of HBI-8000 when combined with a standard dose and regimen of nivolumab, to determine Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) and to evaluate frequency and severity of toxicities of this combination treatment. Secondary: - 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 patients treated at RP2D. - To obtain pharmacokinetics of twice weekly HBI-8000 when administered in combination with nivolumab administered once every two weeks. - To characterize the effect of HBI-8000 on the electrocardiogram QTc interval.