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

Sponsor

HUYABIO International, LLC. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05141357

Collaborator

(none)

Enrollment

Locations

Arm

34.7

Anticipated Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer	Drug: HBI-8000 in combination with pembrolizumab	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Mar 14, 2022

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Feb 1, 2025

Arms and Interventions

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: tudicdinostat Keytruda® pembrolizumab

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:

tudicdinostat

Keytruda®

pembrolizumab

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Duration of response (DoR) [up to 38 months approximately]
Time from 1st observation of objective response to disease progression
Disease Control Rate (DCR) [up to 38 months approximately]
The proportion of subjects achieving complete response, partial response or stable disease
Progression-Free Survival (PFS) [38 months]
Time from the first dose of HBI-8000 to disease progression or death
Safety and tolerability of HBI-8000 when administered in combination with standard dose and regimen of pembrolizumab [From first enrolled up to 38 months, approximately]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Western Regional Medical Center	Goodyear	Arizona	United States	85338
2	Hematology Oncology Associates Of The Treasure Coast	Port Saint Lucie	Florida	United States	34952
3	Southeastern Regional Medical Center	Newnan	Georgia	United States	30265
4	Midewestern Regional Medical Center, LLC	Zion	Illinois	United States	60099
5	Cotton O'Neil Clinical Research Center	Topeka	Kansas	United States	66606
6	Frederick Health-JMSCI	Frederick	Maryland	United States	21702