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History of Changes for Study: NCT02718066
Study of HBI-8000 With Nivolumab in Melanoma, Renal Cell Carcinoma and Non-Small Cell Lung Cancer
Latest version (submitted October 12, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 23, 2016 None (earliest Version on record)
2 September 2, 2016 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 March 16, 2018 Contacts/Locations, Study Status, Arms and Interventions, Study Description, Eligibility, Conditions and Study Identification
4 April 6, 2018 Study Status and Contacts/Locations
5 February 26, 2019 Study Status and Contacts/Locations
6 October 30, 2019 Outcome Measures, Arms and Interventions, Study Description, Oversight, Study Status, Eligibility, Study Design and Sponsor/Collaborators
7 November 4, 2021 Recruitment Status, Study Status, Contacts/Locations and Study Design
8 June 11, 2022 Study Status and Study Identification
9 October 12, 2022 Study Status
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Study NCT02718066
Submitted Date:  March 23, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: HBI-8000-302
Brief Title: Study of HBI-8000 With Nivolumab in Melanoma, Renal Cell Carcinoma and Non-Small Cell Lung Cancer
Official Title: 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)
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2016
Overall Status: Not yet recruiting
Study Start: September 2016
Primary Completion: December 2018 [Anticipated]
Study Completion:
First Submitted: March 15, 2016
First Submitted that
Met QC Criteria:
March 23, 2016
First Posted: March 24, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
March 23, 2016
Last Update Posted: March 24, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: HUYABIO International, LLC.
Responsible Party: Sponsor
Collaborators: Quintiles, Inc.
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief 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 will be:

• 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 objectives will 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 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 QT interval corrected (QTc) interval.

Dose Escalation Phase (1b) will include up to 18 patients, followed by Cohort Expansion Phase (2) including up to 20 patients per tumor indication at MTD and/or RP2D.

Detailed Description:

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 will be:

• 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 objectives will 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 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. Dose Escalation Phase (1b) will include up to 18 patients, followed by Cohort Expansion Phase (2) including up to 20 patients per tumor indication at MTD and/or RP2D.

HBI-8000 tablets will be administered at 20, 30, 40 mg/dose, orally twice a week until MTD or 40 mg in Phase 2, if MTD is not reached.

Nivolumab will be administered at a standard dose 3 mg/kg intravenous infusions every 2 weeks.

A treatment cycle consists of 28 days.

Treatment continues until disease progression or unacceptable toxicities.

Open or close this module Conditions
Conditions: Melanoma
Renal Cell Carcinoma
Non-Small Cell Lung Cancer
Keywords: HBI-8000
nivolumab
Melanoma
Renal Cell Carcinoma
Non-Small Cell Lung Cancer
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 78 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: HBI-8000 in combination with nivolumab
HBI-8000 dose escalation 20mg, 30mg, 40mg, orally, twice weekly; in combination with Nivolumab 3mg/kg once every 2 weeks, intravenous infusions, 60 minutes.
Drug: HBI-8000 in combination with nivolumab
Phase 1b: HBI-8000, orally, twice a week, dose escalation 20 mg, 30 mg, 40 mg; in combination with nivolumab 3 mg/kg by 60 minutes intravenous infusion once every 2 weeks; for Phase 2: HBI-8000 MTD or 40 mg; in combination with nivolumab 3 mg/kg by 60 minutes intravenous infusion once every 2 weeks.
Other Names:
  • For HBI-8000: chidamide, CS055; for nivolumab: OPDIVO
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Determination of the Recommended for Phase 2 Dose (RP2D) (mg)
[ Time Frame: 12 months ]

Secondary Outcome Measures:
1. Efficacy Outcome: Response Rate (%).
[ Time Frame: 18 months ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Patients may be entered in the study only if they meet all of the following criteria:
    1. Adults at least 18 years of age.
    2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
    3. Patients with histopathologically or cytologically confirmed diagnosis of Melanoma, RCC or NSCLC, for whom the use of nivolumab is indicated.
    4. Must have at least one measurable target lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1.
    5. All prior chemotherapy, surgical or radiation treatment must have been completed at least 4 weeks before study drug administration (2 weeks for palliative radiotherapy, 1 week for minor surgery) pending full recovery from therapy
    6. The following laboratory results within 14 days prior to study drug administration: Adequate hematopoietic, electrolyte, hepatic, and renal laboratory findings as defined below: White Blood Cells (WBC) ≥ 3000/μL, Neutrophils ≥ 1500/μL, Platelets ≥ 100x103/μL, Hemoglobin ≥ 9.0 g/dL, Creatinine ≤ 1.5 mg/dL, Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 3 x ULN, Alkaline phosphatase ≤ 2.5 x Upper Limit of Normal (ULN) unless bone metastases present, Bilirubin ≤ 1.5 x ULN (unless known Gilbert's disease where it must be ≤3xULN)
    7. Life expectancy ≥ 12 weeks.
    8. A negative serum pregnancy test at screening for women of childbearing potential.
    9. Are willing to abstain from heterosexual activity or practice physical barrier contraception prior to time of study entry to 6 months after the last day of treatment.
    10. Have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Patients who fulfill any of the following criteria at screening will not be eligible for admission into the study:
    1. Having received immune checkpoint inhibitors previously. Prior therapy with ipilimumab for melanoma is allowed.
    2. History of Grade 3 or above hypersensitivity reactions to other monoclonal antibodies.
    3. Subjects with a history of a cardiovascular illness including: congestive heart failure (New York Heart Association grade III or IV); unstable angina or myocardial infarction within the previous 6 months; or symptomatic cardiac arrhythmia despite medical management.
    4. Uncontrolled hypertension, Systolic Blood Pressure (SBP)> 160 or Diastolic Blood Pressure (DBP)>100.
    5. Patients with brain metastasis, unless stable for 4 weeks or more and not requiring steroids.
    6. Presence of leptomeningeal disease.
    7. History of hemorrhagic diarrhea, inflammatory bowel disease or active uncontrolled peptic ulcer disease.
    8. Active, known, or suspected autoimmune disease, except for type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia).
    9. Active uncontrolled bacterial, viral, or fungal infection requiring systemic therapy.
    10. Infection with human immunodeficiency virus (HIV) or active hepatitis A, B (serum hepatitis B surface antigen positive), or C (serum hepatitis C RNA positive), tested at screening.
    11. Concurrent medical condition requiring the use of immunosuppressive medications, or systemic steroids (prednisone dose is more than 10 mg/day or equivalent). Topical corticosteroids are allowed.
    12. Use of other investigational drugs (drugs not marketed for any indication) within 28 days or at least 5 half-lives (whichever is longer) before study drug administration.
    13. Pregnant or breast-feeding women.
    14. Second malignancy unless in remission for 2 years (non-melanomatous skin cancer or carcinoma in situ of the cervix treated with curative intent is not exclusionary).
    15. Underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity determination or adverse events.
    16. Unwilling or unable to comply with procedures required in this protocol.
Open or close this module Contacts/Locations
Central Contact Person: Dmitri Kharkevitch, MD, PhD
Telephone: 858-798-8800
Email: dkharkevitch@huyabio.com
Study Officials: Nikhil I Khushalani, MD
Principal Investigator
H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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