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

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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Drug: HBI-8000 in combination with pembrolizumab

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Goodyear, Arizona, United States, 85338
      • Western Regional Medical Center
  • California
    • Bakersfield, California, United States, 93309
      • CBCC Global Research, INC at Comprehensive Blood and Cancer Center
  • Florida
    • Port Saint Lucie, Florida, United States, 34952
      • Hematology Oncology Associates of the Treasure Coast
  • Georgia
    • Newnan, Georgia, United States, 30265
      • Southeastern Regional Medical Center
  • Illinois
    • Zion, Illinois, United States, 60099
      • Midewestern Regional Medical Center, LLC
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Cotton O'Neil Clinical Research Center
  • Maryland
    • Frederick, Maryland, United States, 21702
      • Frederick Health-JMSCI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Histopathologically confirmed diagnosis of NSCLC with PD-L1 expression of ≥1% based on FDA-approved test
• No prior treatment with checkpoint inhibitors or more than one regimen of chemotherapy including epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutation directed therapy for advanced or metastatic disease
• Disease must have at least 1 measurable target lesion by RECIST 1.1
• Adequate major organ functions as evidenced by laboratory findings within 14 days prior to first dose
• Eastern Cooperative Oncology Group (ECOG) ≤2 and must have a life expectancy of ≥12 weeks

Exclusion Criteria:

• History of grade ≥3 hypersensitivity reactions to monoclonal antibodies
• Participation in another interventional clinical trial within 28 days or less than 5 half-lives of investigational agent before the first dose
• Recurrent pleural effusion requiring repetitive palliative thoracentesis within 3 months prior to study entry (except patients with a PleurX™ port)
• Active, known or suspected autoimmune disease or history of immune-mediated toxicity leading to discontinuation of previous checkpoint inhibitor treatment should be administered in (neo)adjuvant setting. Exceptions are for type I diabetes mellitus, hyperthyroidism requiring hormone-replacement or skin only 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
• Received approved live vaccines within 30 days of planned first dose. Intranasal influenza vaccines (e.g. Flu-Mist) are not allowed, however inactivated viral vaccines or vaccines based on subviral component are allowed
• Any condition requiring chronic systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications. And any steroids use within 14 days of first dose except for inhaled or topical steroids.

Note: Other protocol-defined Inclusion/Exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HBI-8000 in combination with pembrolizumab	Drug: HBI-8000 in combination with pembrolizumab; 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.; Other Names: pembrolizumab; Keytruda®; tudicdinostat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	The proportion of subjects achieving complete response or partial response according to RECIST v1.1	From enrollment until disease progression or unacceptable toxicity, assessed up to 38 months approximately

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of response (DoR)	Time from 1st observation of objective response to disease progression	up to 38 months approximately
Disease Control Rate (DCR)	The proportion of subjects achieving complete response, partial response or stable disease	up to 38 months approximately
Progression-Free Survival (PFS)	Time from the first dose of HBI-8000 to disease progression or death	38 months
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 first enrolled up to 38 months, approximately

Collaborators and Investigators

• Sponsor: HUYABIO International, LLC.

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2022
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): February 1, 2025

Study Registration Dates

• First Submitted: November 19, 2021
• First Submitted That Met QC Criteria: November 19, 2021
• First Posted (Actual): December 2, 2021

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: December 5, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: NSCLC; Pembrolizumab; HBI-8000
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents; Antineoplastic Agents, Immunological; Pembrolizumab
• Other Study ID Numbers: HBI-8000-305

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No