GT90001 Plus Nivolumab in Patients With Advanced Hepatocellular Carcinoma

Part of paid clinical trials in Duarte, California.

Sponsor
Suzhou Kintor Pharmaceutical Inc,
Study ID
NCT05178043
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Nivolumab 240mg to be administered as an intravenous (IV) infusion every 2 weeks (Q2W).
  • GT90001 — DRUG
    GT90001 7mg/kg to be administered as an intravenous infusion every 2 weeks (Q2W) after Nivolumab infusion.

Study Details

This is a global phase II, open label study in the subjects with Advanced Hepatocellular Carcinoma (aHCC) who were intolerant or had progressed after or intolerant to first-line Immune Checkpoint Inhibitors (ICI) such as Atezolizumab plus Bevacizumab, or ICI plus Tyrosine Kinase Inhibitor (TKI). Based on published and first-hand experience with the safety and tolerability of both GT90001 and Nivolumab, the proposed dose is GT90001 7 mg/kg in combination with Nivolumab 240 mg, infusion every two weeks. This study will enroll a total of 105 subjects to receive combinational therapy of Nivolumab and GT90001. • Nivolumab 240 mg will first be administered by intravenous infusion over 30 minutes, then 30 minutes later, give intravenous infusion of GT90001 7.0 mg/kg over 60 min, once every two weeks.

Key Dates

Start date
Aug 1, 2021
Status verified
Feb 2024
Primary completion
Apr 1, 2025
Completion
Dec 1, 2025

Study Design

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

Arms

  • Experimental: GT90001+Nivolumab

Primary Outcome Measure

The Objective Response Rate (ORR) (confirmed) as evaluated by an Independent Review Committee (IRC) according to RECIST v1.1 [ Time Frame: Approximately 2 years ]

Locations (5)

FacilityCityStateZIPSite coordinators
City of Hope National Medical CenterDuarteCalifornia91010-
Los Angeles Hematology Oncology Medical GroupLos AngelesCalifornia90017-
NYU Langone HealthNew YorkNew York10016-
Renovatio ClinicalHoustonTexas77056-
Medical Oncology AssociatesSpokaneWashington99208-

Find similar trials in Duarte, CA

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By specialty
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By research site
City of Hope National Medical Center· Duarte, CALos Angeles Hematology Oncology Medical Group· Los Angeles, CANYU Langone Health· New York, NYRenovatio Clinical· Houston, TXMedical Oncology Associates· Spokane, WA

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