MelanomaPhase 1/2NCT02718066
Study of HBI-8000 With Nivolumab in Melanoma, Renal Cell Carcinoma and Non-Small Cell Lung Cancer
A Phase 1/2 study testing HBI-8000 in combination with nivolumab in people with Melanoma and Renal Cell Carcinoma, run by HUYABIO International, LLC. at 6 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Renal Cell Carcinoma, Non-Small Cell Lung Cancer
- What is being tested?
- HBI-8000 in combination with nivolumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 6 sitesUnited States
- Study dates
- 18 Aug 2016to 12 Dec 2023
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects were entered in the study only if they met all of the following criteria:
- 1. Adults at least 18 years of age. 2. Eastern Cooperative Oncology Group (ECOG) performance status ≤1. 3.
- Subjects with histopathologically or cytologically confirmed diagnosis of non uveal melanoma, RCC, or NSCLC, for whom the use of nivolumab was indicated. NSCLC subjects with EGFR or ALK genomic aberrations in tumor should have disease progression on FDA approved therapy for these aberrations prior to receiving nivolumab. (Phase 1b).
- Subjects with histopathologically or cytologically confirmed diagnosis of non uveal melanoma or NSCLC for whom the use of nivolumab is indicated (Phase 2 expansion). With Protocol Amendment 5, subjects with NSCLC were not eligible for enrollment.
- c, Non uveal melanoma and NSCLC subjects whose disease progressed after achieving stable disease (SD) for at least 3 months, with partial response (PR) or complete response (CR) as the best response that was documented by imaging studies on previous treatment with a PD L1 inhibitor with proven efficacy (Phase 2 expansion). With Protocol Amendment 5, subjects with NSCLC were not eligible for enrollment.
- 4. Subject had at least one measurable target lesion as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1). Melanoma subjects participating in the optional correlative substudy had tumor tissue available from a metastatic or unresectable site for PD L1 and correlative biomarker analysis.
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- 5. All prior systemic therapy (chemotherapy, mutation targeting therapy, immune checkpoint therapy), or surgical or radiation treatment was 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 7 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 independent of transfusion, creatinine ≤1.5 mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 × upper limit of normal (ULN), alkaline phosphatase ≤2.5 x ULN (unless bone metastases present), bilirubin ≤1.5 × ULN (unless known Gilbert's disease, where value must be ≤3 × ULN), and serum albumin ≥3.0 g/dL.
- 7. Life expectancy ≥12 weeks. 8. A negative serum pregnancy test at baseline for women of childbearing potential.
- 9. Were willing to abstain from heterosexual activity or practice physical barrier contraception prior to time of study entry to at least 5 months after the last day of treatment.
- 10. Had the ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Subjects who fulfilled any of the following criteria at screening were not eligible for admission into the study:
- History of Grade 3 or above hypersensitivity reactions to other monoclonal antibodies.
- 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. In addition, for Phase 1b only: QTc (Fridericia's correction) (QTcF) >450 ms in male, and >470 ms in female, congenital long QT syndrome.
- Uncontrolled hypertension, systolic blood pressure (SBP) >160 mmHg or diastolic blood pressure (DBP) >100 mmHg.
- Subjects with active brain metastasis; previously treated brain metastasis was allowed if it had been stable for 4 weeks or more and had not required steroids.
- Presence of leptomeningeal disease.
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- History of hemorrhagic diarrhea, inflammatory bowel disease, active uncontrolled peptic ulcer disease, recurrent pleural effusion requiring repetitive palliative thoracentesis within 3 months prior to study entry (except for subjects with a pleurex port), or immune mediated toxicity leading to treatment discontinuation.
- Active, known, or suspected serious autoimmune disease, except for type I diabetes mellitus, hypothyroidism only requiring hormone replacement, and skin disorders (such as vitiligo, psoriasis, or alopecia).
- Active uncontrolled bacterial, viral, or fungal infection requiring systemic therapy.
- Known history of testing positive for human immunodeficiency virus (HIV), known acquired immunodeficiency syndrome (AIDS).
- Active hepatitis B (serum hepatitis B surface antigen [HBsAg] positive) or hepatitis C (hepatitis C virus [HCV] antibody test or serum HCV RNA positive) indicating acute or chronic infection.
- Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids were permitted.
- Use of other investigational agents (drugs not marketed for any indication) within 28 days or at least 5 half lives (whichever is shorter) before study drug administration.
- Pregnant or breast feeding women.
- Second malignancy unless in remission for 2 years, except for non melanomatous skin cancer, carcinoma in situ of the cervix treated with curative intent, or curatively treated prostate cancer with prostate specific antigen (PSA) <0.1 ng/mL.
- Underlying medical conditions that, in the Investigator's opinion, made the administration of study drug hazardous or obscure the interpretation of toxicity determination or adverse events.
- Unwilling or unable to comply with procedures required in this protocol.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
[Site 13] Frederick Memorial Hospital d/b/a James M Stockman Cancer Institute
Frederick, Maryland, 21702
[Site 12] University of Texas M.D. Anderson Cancer Center - Investigational Cancer Therapeutics
Houston, Texas, 77030
[Site 11] University of California, San Diego Medical Center
La Jolla, California, 92037
[Site 02] Mayo Clinic Arizona
Phoenix, Arizona, 85054
[Site 01] Hematology - Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, 34952
[Site 09] H. Lee Moffitt Cancer Center and Research Institute, Inc.
Tampa, Florida, 33612
About this study
Official title: A Phase 1b/2 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)
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:
Read more
-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 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 and/or RP2D.
Read the 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 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) and/or 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 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: 240 mg intravenous infusions every 2 weeks for Phase 1b and in accordance with the manufacturer package insert and institution's prescribing practice for Phase 2.
A treatment cycle consists of 28 days. Treatment continues until disease progression or unacceptable toxicity.
- Conditions
- Melanoma, Renal Cell Carcinoma, Non-Small Cell Lung Cancer
- Being tested
- HBI-8000 in combination with nivolumab
- Keywords
- HBI-8000, Nivolumab, Melanoma, Renal Cell Carcinoma, Non-Small Cell Lung Cancer
- Medical subject headings
- Melanoma, Carcinoma, Renal Cell, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBI-8000 in combination with nivolumabDrug
Also called For HBI-8000: Chidamide, CS055; for nivolumab: OPDIVO
Phase 1b: HBI-8000, orally, twice a week, dose escalation 20mg, 30mg, 40mg; in combination with nivolumab 240mg intravenous infusion every 2 weeks.
Phase 2: HBI-8000 MTD or 40mg; in combination with nivolumab in accordance with the manufacturer package insert and institution's prescribing practice.
| Study group | Role | What they receive |
|---|---|---|
| HBI-8000 in combination with nivolumab | Experimental | HBI-8000 dose escalation 20mg, 30mg, 40mg, orally, twice weekly; in combination with Nivolumab 240mg intravenous infusions every 2 weeks for Phase 1b and in accordance with the manufacturer package insert and institution's prescribing practice for Phase 2. Receives: Drug: HBI-8000 in combination with nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Who Experienced at Least One DLT During the DLT Assessment Period for MTD Determination
The dose escalation schema of HBI 8000 followed the conventional 3+3 design. The starting dose was HBI 8000 20 mg twice a week. Dose escalation to 30 mg or 40 mg was determined by observation of DLT. At each dose level, a minimum of 3 subjects evaluable for DLT were enrolled. If 0 of the initial 3, or no more than 1 in a total 6 subjects experienced DLT, escalation to the next higher dose was allowed.
Measured: First 28 days
Secondary outcomes (14)
Objective Response Rate (ORR) in All Patients Treated at RP2D
Percentage of patients with complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
Measured: From screening for baseline assessment to the date of CR or PR assessed, up to approximately 4 years and 7 months
Disease Control Rate (DCR) in All Patients Treated at RP2D
Percentage of patients with complete response (CR), partial response (PR) or stable disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
Measured: From screening for baseline assessment to the date of best response (CR, PR, or SD) on study, up to approximately 4 years and 7 months
Duration of Response (DoR) in All Patients Treated at RP2D
Time from the first assessment of CR or PR until the date of the first occurrence of PD, or until the date of death.
Measured: From the date of CR or PR until the date of PD, or until the date of death, up to approximately 4 years and 7 months
Progression-Free Survival (PFS) in All Patients Treated at RP2D
Time from the date of first dose of HBI-8000 until tumor progression by site reported RECIST 1.1, or clinical progression, or death, whichever occurs first. If tumor progression data include more than 1 date of progression, the earliest date will be used.
Measured: From the date of first dose of HBI-8000 until tumor progression by site reported RECIST 1.1, or clinical progression, or death, whichever occurs first, up to approximately 4 years and 7 months
Pharmacokinetic - Cmax (Single Dosing)
Maximum observed plasma concentration, obtained directly from the observed concentration versus time data.
Measured: From predose (0.5 hour prior to breakfast) to 7 hours postdose on Cycle 1 Day 1, at 24 hours on Cycle 1 Day 2 (no dose administered)
Pharmacokinetic - Cmax (Repeat Dosing)
Maximum observed plasma concentration, obtained directly from the observed concentration versus time data.
Measured: From predose to 7 hours postdose on Cycle 2 Day 1
Pharmacokinetic - AUC(0-7) (Single Dosing)
Area under the plasma concentration time curve from zero (predose) to 7 hours postdose, calculated by linear up/log down trapezoidal summation.
Measured: From predose (0.5 hour prior to breakfast) to 7 hours postdose on Cycle 1 Day 1
Pharmacokinetic - AUC(0-7) (Repeat Dosing)
Area under the plasma concentration time curve from zero (predose) to 7 hours postdose, calculated by linear up/log down trapezoidal summation.
Measured: From predose to 7 hours postdose on Cycle 2 Day 1
Pharmacokinetic - AUC(0-24)
Area under the plasma concentration time curve from zero (predose) to 24 hours postdose, calculated by linear up/log down trapezoidal summation. Calculated for C1D1 only.
Measured: From predose (0.5 hour prior to breakfast) on Cycle 1 Day 1 to 24 hours on Cycle 1 Day 2 (no dose administered)
Pharmacokinetic - Tmax (Single Dosing)
Time of Cmax, obtained directly from the observed concentration versus time data.
Measured: From predose (0.5 hour prior to breakfast) to 7 hours postdose on Cycle 1 Day 1, at 24 hours on Cycle 1 Day 2 (no dose administered)
Pharmacokinetic - Tmax (Repeat Dosing)
Time of Cmax, obtained directly from the observed concentration versus time data.
Measured: From predose to 24 hours postdose on Cycle 2 Day 1
QTcF Values >450 Msec
Utilized a random coefficients mixed effects model for the change from baseline (ΔQTcF) values with continuous effects for HBI 8000 plasma concentration and baseline value (corrected for overall baseline mean), plus subject level random effects for intercept and concentration slope under unstructured covariance.
Measured: 0 (predose) up to 4 hours postdose on C1D1 and C2D1
QTcF Increase > 30 Msec
Utilized a random coefficients mixed effects model for the change from baseline (ΔQTcF) values with continuous effects for HBI 8000 plasma concentration and baseline value (corrected for overall baseline mean), plus subject level random effects for intercept and concentration slope under unstructured covariance.
Measured: 0 (predose) up to 4 hours postdose on C1D1 and C2D1
Concentration Slope
Slope estimate between ΔQTcF and HBI 8000 concentrations
Measured: 0 (predose) up to 4 hours postdose on C1D1 and C2D1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study start18 Aug 2016
- Primary completion12 Dec 2023
- Study completion12 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- HUYABIO International, LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nikhil I Khushalani, MD, Principal investigator, H. Lee Moffitt Cancer Center and Research Institute, Inc., Tampa, FL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02718066
- Sponsor's protocol ID
- HBI-8000-302
- Status last verified
- Apr 2026
- First submitted
- 15 Mar 2016
- Last updated
- 30 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2 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)
- ClinicalTrials.gov ID
- NCT02718066
- Acronym / sponsor ID
- HBI-8000-302
- Conditions
- Melanoma, Renal Cell Carcinoma, Non-Small Cell Lung Cancer
- Keywords
- HBI-8000, Nivolumab, Melanoma, Renal Cell Carcinoma, Non-Small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- HUYABIO International, LLC.Industry (pharma, biotech, devices)
- Study start
- 18 Aug 2016 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 24 Mar 2016 (estimated)
- Results
- Posted 30 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 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 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) and/or 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 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: 240 mg intravenous infusions every 2 weeks for Phase 1b and in accordance with the manufacturer package insert and institution's prescribing practice for Phase 2.
A treatment cycle consists of 28 days. Treatment continues until disease progression or unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HBI-8000 in combination with nivolumab | Experimental | Drug: HBI-8000 in combination with nivolumabHBI-8000 dose escalation 20mg, 30mg, 40mg, orally, twice weekly; in combination with Nivolumab 240mg intravenous infusions every 2 weeks for Phase 1b and in accordance with the manufacturer package insert and institution's prescribing practice for Phase 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 1. Adults at least 18 years of age. 2. Eastern Cooperative Oncology Group (ECOG) performance status ≤1. 3.
- Subjects with histopathologically or cytologically confirmed diagnosis of non uveal melanoma, RCC, or NSCLC, for whom the use of nivolumab was indicated. NSCLC subjects with EGFR or ALK genomic aberrations in tumor should have disease progression on FDA approved therapy for these aberrations prior to receiving nivolumab. (Phase 1b).
- Subjects with histopathologically or cytologically confirmed diagnosis of non uveal melanoma or NSCLC for whom the use of nivolumab is indicated (Phase 2 expansion). With Protocol Amendment 5, subjects with NSCLC were not eligible for enrollment.
- c, Non uveal melanoma and NSCLC subjects whose disease progressed after achieving stable disease (SD) for at least 3 months, with partial response (PR) or complete response (CR) as the best response that was documented by imaging studies on previous treatment with a PD L1 inhibitor with proven efficacy (Phase 2 expansion). With Protocol Amendment 5, subjects with NSCLC were not eligible for enrollment.
- 4. Subject had at least one measurable target lesion as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1). Melanoma subjects participating in the optional correlative substudy had tumor tissue available from a metastatic or unresectable site for PD L1 and correlative biomarker analysis.
Key exclusion criteria (17 listed)
- Subjects who fulfilled any of the following criteria at screening were not eligible for admission into the study:
- History of Grade 3 or above hypersensitivity reactions to other monoclonal antibodies.
- 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. In addition, for Phase 1b only: QTc (Fridericia's correction) (QTcF) >450 ms in male, and >470 ms in female, congenital long QT syndrome.
- Uncontrolled hypertension, systolic blood pressure (SBP) >160 mmHg or diastolic blood pressure (DBP) >100 mmHg.
- Subjects with active brain metastasis; previously treated brain metastasis was allowed if it had been stable for 4 weeks or more and had not required steroids.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HBI-8000 in combination with nivolumabAlso: For HBI-8000: Chidamide, CS055; for nivolumab: OPDIVOPhase 1b: HBI-8000, orally, twice a week, dose escalation 20mg, 30mg, 40mg; in combination with nivolumab 240mg intravenous infusion every 2 weeks. Phase 2: HBI-8000 MTD or 40mg; in combination with nivolumab in accordance with the manufacturer package insert and institution's prescribing practice. | Drug | HBI-8000 in combination with nivolumab |
Primary outcome
Number of Patients Who Experienced at Least One DLT During the DLT Assessment Period for MTD Determination
Time frame: First 28 days
The dose escalation schema of HBI 8000 followed the conventional 3+3 design. The starting dose was HBI 8000 20 mg twice a week. Dose escalation to 30 mg or 40 mg was determined by observation of DLT. At each dose level, a minimum of 3 subjects evaluable for DLT were enrolled. If 0 of the initial 3, or no more than 1 in a total 6 subjects experienced DLT, escalation to the next higher dose was allowed.
14 secondary outcomes
Objective Response Rate (ORR) in All Patients Treated at RP2D
Time frame: From screening for baseline assessment to the date of CR or PR assessed, up to approximately 4 years and 7 months
Disease Control Rate (DCR) in All Patients Treated at RP2D
Time frame: From screening for baseline assessment to the date of best response (CR, PR, or SD) on study, up to approximately 4 years and 7 months
Duration of Response (DoR) in All Patients Treated at RP2D
Time frame: From the date of CR or PR until the date of PD, or until the date of death, up to approximately 4 years and 7 months
Progression-Free Survival (PFS) in All Patients Treated at RP2D
Time frame: From the date of first dose of HBI-8000 until tumor progression by site reported RECIST 1.1, or clinical progression, or death, whichever occurs first, up to approximately 4 years and 7 months
Pharmacokinetic - Cmax (Single Dosing)
Time frame: From predose (0.5 hour prior to breakfast) to 7 hours postdose on Cycle 1 Day 1, at 24 hours on Cycle 1 Day 2 (no dose administered)
Pharmacokinetic - Cmax (Repeat Dosing)
Time frame: From predose to 7 hours postdose on Cycle 2 Day 1
Pharmacokinetic - AUC(0-7) (Single Dosing)
Time frame: From predose (0.5 hour prior to breakfast) to 7 hours postdose on Cycle 1 Day 1
Pharmacokinetic - AUC(0-7) (Repeat Dosing)
Time frame: From predose to 7 hours postdose on Cycle 2 Day 1
Pharmacokinetic - AUC(0-24)
Time frame: From predose (0.5 hour prior to breakfast) on Cycle 1 Day 1 to 24 hours on Cycle 1 Day 2 (no dose administered)
Pharmacokinetic - Tmax (Single Dosing)
Time frame: From predose (0.5 hour prior to breakfast) to 7 hours postdose on Cycle 1 Day 1, at 24 hours on Cycle 1 Day 2 (no dose administered)
Pharmacokinetic - Tmax (Repeat Dosing)
Time frame: From predose to 24 hours postdose on Cycle 2 Day 1
QTcF Values >450 Msec
Time frame: 0 (predose) up to 4 hours postdose on C1D1 and C2D1
QTcF Increase > 30 Msec
Time frame: 0 (predose) up to 4 hours postdose on C1D1 and C2D1
Concentration Slope
Time frame: 0 (predose) up to 4 hours postdose on C1D1 and C2D1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Melanoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikhil I Khushalani, MD principal investigator
H. Lee Moffitt Cancer Center and Research Institute, Inc., Tampa, FL
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HBI-8000 in combination with nivolumab in people with Melanoma and Renal Cell Carcinoma, run by HUYABIO International, LLC. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients Who Experienced at Least One DLT During the DLT Assessment Period for MTD Determination (time frame: First 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.