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A Study of HBI-8000 (Tucidinostat) With Pembrolizumab in Non-Small Cell Lung Cancer | Clinical Trials | Clareo Health

TERMINATEDPHASE2

A Study of HBI-8000 (Tucidinostat) With Pembrolizumab in Non-Small Cell Lung Cancer

A Phase 2 Study to Assess the Safety and Efficacy of HBI-8000 in Combination With Pembrolizumab for Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

NCT05141357•HUYABIO International, LLC.

View on ClinicalTrials.gov

Summary

A Phase 2 Study to Assess the Safety and Efficacy of HBI-8000 in Combination with Pembrolizumab for Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Detailed Description

This Phase 2 study evaluates HBI-8000, a histone deacetylase inhibitor (HDACi) in combination with pembrolizumab for the treatment of patients with advanced or metastatic non-small cell lung cancer who possess programmed death ligand 1 (PD-L1) expression Tumor Proportion Score (TPS) of 1% or greater. The Treatment Phase allowed for up to 24 months of treatment (cycles were 21 days), providing the subject did not experience disease progression or unacceptable toxicity.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Adults at least 18 years of age.
•2. Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
•3. Histopathologically confirmed diagnosis of NSCLC PD-L1 expression TPS ≥1% as determined by an FDA-approved test.
•4. Have at least one measurable target lesion as defined by RECIST v.1.1.
•5. Have not received immune checkpoint inhibitor therapy or more than one regimen of chemotherapy for advanced or metastatic disease. Subjects who have previously received immune checkpoint inhibitor therapy in the adjuvant or neoadjuvant setting may be allowed if disease progression occurred \>6 months after the last dose and no clinically significant immune related toxicities leading to treatment discontinuation were observed.
•6. Prior adjuvant or neoadjuvant systemic therapy with chemotherapy, EGFR or ALK mutation directed therapy must have been completed \>4 weeks before Cycle 1 Day 1 (C1D1) dosing and recovered from all treatment related toxicity.
•7. Any prior palliative radiotherapy or minor surgery must be completed at least 2 weeks and 1 week respectively before C1D1 dosing and recovered from all treatment related toxicities.
•8. Adequate major organ functions at baseline as evidenced by laboratory findings within 14 days prior to C1D1 study drug administration as defined below:
•1. White blood cells (WBC) ≥3000/μL, neutrophils ≥1500/μL, platelets ≥100×103/μL, hemoglobin ≥9.0 g/dL, independent of transfusion.
•2. Serum creatinine ≤1.5 mg/dL, normal electrolytes, phosphorus, and calcium.
+6 more criteria

Exclusion Criteria

•1. History of Grade ≥3 hypersensitivity reactions to monoclonal antibodies.
•2. History of a cardiovascular illness including: QT interval corrected by heart rate using Fridericia's correction formula (QTcF) \>450 ms in male or \>470 ms in female, congenital long QT syndrome, congestive heart failure (New York Heart Association Grade III or IV) (Protocol Appendix 2); unstable angina or myocardial infarction within the previous 6 months; or symptomatic cardiac arrhythmia despite medical management.
•3. Uncontrolled hypertension, systolic blood pressure (SBP) \>160 mmHg or diastolic blood pressure (DBP) \>100 mmHg.
•4. Central nervous system metastasis or leptomeningeal disease except when treatment for brain metastasis is completed \>14 days prior to C1D1 and stable for ≥4 weeks on \<10 mg daily prednisone or equivalent.
•5. History of hemorrhagic diarrhea, inflammatory bowel disease, active uncontrolled peptic ulcer disease or bowel resection that affects absorption of orally administered drugs.
•6. Recurrent pleural effusion requiring repetitive palliative thoracentesis within 3 months prior to study entry, except for subjects with a pleurex port.
•7. Active, known, or suspected autoimmune disease, or history of immune-mediated toxicity leading to treatment discontinuation, except for type I diabetes mellitus, hypothyroidism only requiring hormone replacement or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic therapy.
•8. Active pneumonitis, history of non-infectious pneumonitis that required treatment with steroids, or history of interstitial lung disease.
•9. Active uncontrolled bacterial, viral, or fungal infection requiring systemic therapy.
•10. Known history of testing positive for human immunodeficiency virus (HIV), known acquired immunodeficiency syndrome (AIDS).
+8 more criteria

Locations (7)

Western Regional Medical Center

Goodyear, Arizona, United States

CBCC Global Research, Inc at Comprehensive Blood and Cancer Center

Bakersfield, California, United States

Hematology Oncology Associates Of The Treasure Coast

Port Saint Lucie, Florida, United States

Southeastern Regional Medical Center

Newnan, Georgia, United States

Midewestern Regional Medical Center, LLC

Zion, Illinois, United States

Cotton O'Neil Clinical Research Center

Topeka, Kansas, United States

Frederick Health-JMSCI

Frederick, Maryland, United States

Key Dates

Start Date

February 15, 2022

Primary Completion Date

April 19, 2023

Completion Date

April 19, 2023

Last Updated

December 24, 2025

Enrollment

ACTUAL participants

Conditions

Non Small Cell Lung Cancer

Interventions

HBI-8000 in combination with pembrolizumab

DRUG

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RECRUITING

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

NCT07485114

Renal Cell Carcinoma (Kidney Cancer)Non Small Cell Lung Cancer+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of HBI-8000 (Tucidinostat) With Pembrolizumab in Non-Small Cell Lung Cancer

Inclusion Criteria

Exclusion Criteria

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

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