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

NCT05141357 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: HBI-8000-305
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 7

Brief 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)

Conditions

Non Small Cell Lung Cancer

Keywords

HBI-8000; Pembrolizumab; NSCLC

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability of HBI-8000 When Administered in Combination With Standard Dose and Regimen of Pembrolizumab

  Number of participants experiencing treatment-emergent adverse events (TEAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0

  From the start of treatment until 30 days after the last dose of HBI-8000, up to approximately 13 months

Study Arms (1)

HBI-8000 in combination with pembrolizumab

EXPERIMENTAL

HBI-8000 - 30 mg/dose, orally twice a week; Pembrolizumab - 400 mg every 6 weeks or 200 mg every 3 weeks according to Prescribing Information and institutional practice

Drug: HBI-8000 in combination with pembrolizumab

Interventions

HBI-8000 in combination with pembrolizumab DRUG

Participants will take 30 mg of HBI-8000 by mouth every 3-4 days on a twice weekly (BIW) schedule. Pembrolizumab will be administered at 400 mg IV every 6 weeks (Q6W) or 200 mg IV every 3 weeks (Q3W) according to Prescribing Information and institution's prescribing practice for pembrolizumab.

Also known as: tucidinostat, Keytruda®, pembrolizumab

HBI-8000 in combination with pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults at least 18 years of age.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
• Histopathologically confirmed diagnosis of NSCLC PD-L1 expression TPS ≥1% as determined by an FDA-approved test.
• Have at least one measurable target lesion as defined by RECIST v.1.1.
• 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.
• 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.
• 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.
• Adequate major organ functions at baseline as evidenced by laboratory findings within 14 days prior to C1D1 study drug administration as defined below:
• White blood cells (WBC) ≥3000/μL, neutrophils ≥1500/μL, platelets ≥100×103/μL, hemoglobin ≥9.0 g/dL, independent of transfusion.
• Serum creatinine ≤1.5 mg/dL, normal electrolytes, phosphorus, and calcium.
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 × upper limit of normal (ULN), alkaline phosphatase ≤2.5 × ULN unless bone metastases present, bilirubin ≤1.5 × ULN (unless known Gilbert's disease where it must be ≤3 × ULN) and serum albumin ≥3.0 g/dL.
• Thyroid stimulating hormone (TSH) within normal limits.
• Life expectancy ≥12 weeks.
• A negative serum pregnancy test at baseline for women of childbearing potential (WOCBP).
• Women of childbearing potential. (WOCBP), non-surgically sterile or premenopausal female capable of becoming pregnant and men (due to potential risk of drug exposure through the ejaculate) must agree to use an acceptable method of contraception while enrolled on this study, and for a period of 5 months following the last dose of treatment. Acceptable methods of birth control in this trial include 2 highly effective methods of birth control (as determined by the Investigator; one of the methods must be a barrier technique) or abstinence.

You may not qualify if:

• History of Grade ≥3 hypersensitivity reactions to monoclonal antibodies.
• 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.
• Uncontrolled hypertension, systolic blood pressure (SBP) \>160 mmHg or diastolic blood pressure (DBP) \>100 mmHg.
• 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.
• History of hemorrhagic diarrhea, inflammatory bowel disease, active uncontrolled peptic ulcer disease or bowel resection that affects absorption of orally administered drugs.
• Recurrent pleural effusion requiring repetitive palliative thoracentesis within 3 months prior to study entry, except for subjects with a pleurex port.
• 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.
• Active pneumonitis, history of non-infectious pneumonitis that required treatment with steroids, or history of interstitial lung disease.
• 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 (hepatitis B surface antigen \[HBVsAg\] positive), or hepatitis C (HCV antibody test or serum hepatitis C ribonucleic acid \[RNA\] positive).
• Received approved live vaccines within 30 days of planned C1D1. Inactivated viral vaccines or vaccines based on subviral component are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are not allowed. COVID-19 vaccination should be administered \>7 days before C1D1.
• Any condition requiring chronic systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications, or steroids use within 14 days of study drug administration. Inhaled or topical steroids are permitted.
• Use of other investigational agent (drug 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.

Sponsors & Collaborators

• HUYABIO International, LLC.: lead

Study Sites (7)

Western Regional Medical Center

Goodyear, Arizona, 85338, United States

Location

CBCC Global Research, Inc at Comprehensive Blood and Cancer Center

Bakersfield, California, 93309, United States

Location

Hematology Oncology Associates Of The Treasure Coast

Port Saint Lucie, Florida, 34952, United States

Location

Southeastern Regional Medical Center

Newnan, Georgia, 30265, United States

Location

Midewestern Regional Medical Center, LLC

Zion, Illinois, 60099, United States

Location

Cotton O'Neil Clinical Research Center

Topeka, Kansas, 66606, United States

Location

Frederick Health-JMSCI

Frederick, Maryland, 21702, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

HBI-8000; pembrolizumab; N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: HUYABIO International

Glee@huyabio.com

(858) 798-8800

Study Officials

• Gloria Lee, MD, PhD

  HUYABIO International, LLC.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: December 2, 2021
• Study Start: February 15, 2022
• Primary Completion: April 19, 2023
• Study Completion: April 19, 2023
• Last Updated: December 24, 2025
• Results First Posted: December 24, 2025

Record last verified: 2025-12

Locations

US (7)