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Trial record 1 of 26 for:    kidney cancer, renal cell carcinoma | Recruiting Studies | United States, Florida | Child, Adult, Senior | Phase 1, 2, 3, 4 | NIH, Industry, Other
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Study of HBI-8000 With Nivolumab in Melanoma, Renal Cell Carcinoma and Non-Small Cell Lung Cancer

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2016 by HUYA Bioscience International
Sponsor:
Collaborator:
Quintiles, Inc.
Information provided by (Responsible Party):
HUYA Bioscience International
ClinicalTrials.gov Identifier:
NCT02718066
First received: March 15, 2016
Last updated: September 2, 2016
Last verified: September 2016
  Purpose

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.


Condition Intervention Phase
Melanoma Renal Cell Carcinoma Non-Small Cell Lung Cancer Drug: HBI-8000 in combination with nivolumab Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by HUYA Bioscience International:

Primary Outcome Measures:
  • Determination of the Recommended for Phase 2 Dose (RP2D) (mg) [ Time Frame: 12 months ]

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

Estimated Enrollment: 78
Study Start Date: August 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
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 Name: For HBI-8000: chidamide, CS055; for nivolumab: OPDIVO

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02718066

Contacts
Contact: Dmitri Kharkevitch, MD, PhD 858-798-8800 dkharkevitch@huyabio.com

Locations
United States, Arizona
MAYO Clinic Recruiting
Phoenix, Arizona, United States, 85054
Contact: THAI HO         
United States, Florida
Hem-Onc Associates of Treasure Coast Recruiting
Port Saint Lucie, Florida, United States, 34952
Contact: Heather Yecks-Rodin, MD         
Sponsors and Collaborators
HUYA Bioscience International
Quintiles, Inc.
Investigators
Principal Investigator: Nikhil I Khushalani, MD H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL
  More Information

Responsible Party: HUYA Bioscience International
ClinicalTrials.gov Identifier: NCT02718066     History of Changes
Other Study ID Numbers: HBI-8000-302
Study First Received: March 15, 2016
Last Updated: September 2, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by HUYA Bioscience International:
HBI-8000
nivolumab
Melanoma
Renal Cell Carcinoma
Non-Small Cell Lung Cancer

Additional relevant MeSH terms:
Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Melanoma
Lung Diseases
Respiratory Tract Diseases
Nevi and Melanomas
Adenocarcinoma
Urologic Diseases
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors

ClinicalTrials.gov processed this record on September 19, 2017