NCT03893695

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

Combination of GT90001 and Nivolumab in Patients With Metastatic Hepatocellular Carcinoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Suzhou Kintor Pharmaceutical Inc, · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

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

Timeline

• Start date: 2019-05-25
• Primary completion: 2022-05-26
• Completion: 2022-09-27
• First posted: 2019-03-28
• Last updated: 2024-02-09

Locations

3 sites across 1 country: Taiwan