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

Non Small Cell Lung Cancer Clinical Trial

— HBI-8000  

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05141357
• Other study ID #: HBI-8000-305
• Status: Terminated
• Phase: Phase 2
• Start date: March 14, 2022
• Est. completion date: April 19, 2023

Study information

• Verified date: November 2023
• Source: HUYABIO International, LLC.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: April 19, 2023
• Est. primary completion date: April 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	CBCC Global Research, Inc at Comprehensive Blood and Cancer Center	Bakersfield	California
United States	Frederick Health-JMSCI	Frederick	Maryland
United States	Western Regional Medical Center	Goodyear	Arizona
United States	Southeastern Regional Medical Center	Newnan	Georgia
United States	Hematology Oncology Associates Of The Treasure Coast	Port Saint Lucie	Florida
United States	Cotton O'Neil Clinical Research Center	Topeka	Kansas
United States	Midewestern Regional Medical Center, LLC	Zion	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
HUYABIO International, LLC.

Country where clinical trial is conducted

United States, 

Outcome

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