Clinical trial NCT05141357: A Study of HBI-8000 (Tucidinostat) With Pembrolizumab in Non-Small Cell Lung Cancer
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Keywords: HBI-8000
Pembrolizumab
NSCLC
Lead sponsor: HUYABIO International, LLC.
Sponsor class: INDUSTRY
First posted: 2021-12-02
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: From enrollment until disease progression or unacceptable toxicity, assessed up to 38 months approximately
Secondary outcomes:
measure: Duration of response (DoR)
timeFrame: up to 38 months approximately
measure: Disease Control Rate (DCR)
timeFrame: up to 38 months approximately
measure: Progression-Free Survival (PFS)
timeFrame: 38 months
measure: Safety and tolerability of HBI-8000 when administered in combination with standard dose and regimen of pembrolizumab
timeFrame: From first enrolled up to 38 months, approximately
Other outcomes:
Locations:
city: Goodyear
country: United States
facility: Western Regional Medical Center
state: Arizona
city: Bakersfield
country: United States
facility: CBCC Global Research, Inc at Comprehensive Blood and Cancer Center
state: California
city: Port Saint Lucie
country: United States
facility: Hematology Oncology Associates Of The Treasure Coast
state: Florida
city: Newnan
country: United States
facility: Southeastern Regional Medical Center
state: Georgia
city: Zion
country: United States
facility: Midewestern Regional Medical Center, LLC
state: Illinois
city: Topeka
country: United States
facility: Cotton O'Neil Clinical Research Center
state: Kansas
city: Frederick
country: United States
facility: Frederick Health-JMSCI
state: Maryland
Study officials:
References: