Ignite Creation Date:
2025-12-24 @ 2:09 PM
Ignite Modification Date:
2026-01-01 @ 12:34 AM
Study NCT ID:
NCT03893695
Status:
COMPLETED
Last Update Posted:
2024-02-09
First Post:
2019-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination of GT90001 and Nivolumab in Patients With Metastatic Hepatocellular Carcinoma(HCC)
Sponsor:
Suzhou Kintor Pharmaceutical Inc,
Organization:
Study Overview
Official Title:
Combination of GT90001 and Nivolumab in Patients With Metastatic Hepatocellular Carcinoma
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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 nivolumb 3 mg/kg. Nivolumab will first be administered by intravenous infusion over 60 minutes, then 30 minutes later, give GT90001 intravenous infusion for 1 hour. All participants will receive GT90001 + Nivolumab until unacceptable toxicity, disease progression or loss of clinical benefit as determined by the investigator.The primary objective of the study is to determine the safety and tolerability of GT90001 in combination with nivolumab in subjects with advanced and or metastatic HCC who were progressed on or were intolerant of first-line and/or second-line systemic therapy. The secondary objectives will be to evaluate the anti-tumor efficacy and the PK profile of this combination therapy.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: