Ignite Creation Date:
2024-05-06 @ 8:19 AM
Last Modification Date:
2024-10-26 @ 11:59 AM
Study NCT ID:
NCT02718066
Status:
COMPLETED
Last Update Posted:
2023-11-09
First Post:
2016-03-15
Brief Title:
Study of HBI-8000 With Nivolumab in Melanoma Renal Cell Carcinoma and Non-Small Cell Lung Cancer
Sponsor:
HUYABIO International LLC
Organization:
HUYABIO International LLC
Study Overview
Official Title:
A Phase 1b2 Study to Assess the Safety and Efficacy of HBI-8000 in Combination With Nivolumab in Subjects With Advanced Solid Tumors Including Melanoma Renal Cell Carcinoma RCC and Non-Small Cell Lung Cancer NSCLC
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A Phase 1b2 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 andor 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 andor RP2D
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 andor 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 andor RP2D
Detailed Description:
A Phase 1b2 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 to determine Maximum Tolerated Dose MTD andor Recommended Phase 2 Dose RP2D 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 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
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 andor RP2D
HBI-8000 tablets will be administered at 20 30 40 mgdose orally twice a week until MTD or 40 mg in Phase 2 if MTD is not reached
Nivolumab 240 mg intravenous infusions every 2 weeks for Phase 1b and in accordance with the manufacturer package insert and institutions prescribing practice for Phase 2
A treatment cycle consists of 28 days Treatment continues until disease progression or unacceptable toxicity
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 to determine Maximum Tolerated Dose MTD andor Recommended Phase 2 Dose RP2D 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 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
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 andor RP2D
HBI-8000 tablets will be administered at 20 30 40 mgdose orally twice a week until MTD or 40 mg in Phase 2 if MTD is not reached
Nivolumab 240 mg intravenous infusions every 2 weeks for Phase 1b and in accordance with the manufacturer package insert and institutions prescribing practice for Phase 2
A treatment cycle consists of 28 days Treatment continues until disease progression or unacceptable toxicity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None