Combination of GT90001 and Nivolumab in Patients With Metastatic Hepatocellular Carcinoma(HCC)

Sponsor
Suzhou Kintor Pharmaceutical Inc,
Study ID
NCT03893695
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Combinations of Drugs; Dependence
  • HCC
  • Metastatic Hepatocellular Carcinoma

Eligibility Criteria

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

Interventions

  • GT90001 and Nivolumab — DRUG
    Stage1:Dose de-escalation. Stage2:the expansion cohort where one or no DLT takes place in planned study cohort.

Study Details

This single arm, open label, two stage study will be conducted in several medical centers around Taiwan. Stage one determine safety and tolerability in patients with HCC, and stage two assess anti-tumor activities of GT90001 in combination with nivolumab in patients with metastatic HCC. Subjects who fulfill all the entry criteria and have written informed consent will be enrolled to the study.

Key Dates

Start date
May 25, 2019
Status verified
Feb 2024
Primary completion
May 26, 2022
Completion
Sep 27, 2022

Study Design

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

Arms

  • Experimental: metastatic HCC
    Stage one - Dose de-escalation: Each dose cohort will assess toxicity within the 28 days following the first dose of nivolumab and GT90001. Stage two- the expansion cohort: 14 patients will be enrolled to the expansion cohort where one or no DLT takes place in planned study cohort.

Primary Outcome Measure

Dose-limiting Toxicity(DLT) [ Time Frame: 28 days ]

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