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

Part of paid clinical trials in Goodyear, Arizona.

Sponsor
HUYABIO International, LLC.
Study ID
NCT05141357
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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)

Key Dates

Start date
Feb 15, 2022
Status verified
Dec 2025
Primary completion
Apr 19, 2023
Completion
Apr 19, 2023

Study Design

Enrollment
5 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: HBI-8000 in combination with pembrolizumab
    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

Primary Outcome Measure

Safety and Tolerability of HBI-8000 When Administered in Combination With Standard Dose and Regimen of Pembrolizumab [ Time Frame: From the start of treatment until 30 days after the last dose of HBI-8000, up to approximately 13 months ]

Locations (7)

FacilityCityStateZIPSite coordinators
Western Regional Medical CenterGoodyearArizona85338-
CBCC Global Research, Inc at Comprehensive Blood and Cancer CenterBakersfieldCalifornia93309-
Hematology Oncology Associates Of The Treasure CoastPort Saint LucieFlorida34952-
Southeastern Regional Medical CenterNewnanGeorgia30265-
Midewestern Regional Medical Center, LLCZionIllinois60099-
Cotton O'Neil Clinical Research CenterTopekaKansas66606-
Frederick Health-JMSCIFrederickMaryland21702-

Related coverage on Hipa.ai

Find similar trials in Goodyear, AZ

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Western Regional Medical Center· Goodyear, AZCBCC Global Research, Inc at Comprehensive Blood and Cancer Center· Bakersfield, CAHematology Oncology Associates Of The Treasure Coast· Port Saint Lucie, FLSoutheastern Regional Medical Center· Newnan, GAMidewestern Regional Medical Center, LLC· Zion, ILCotton O'Neil Clinical Research Center· Topeka, KS

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