GT90001 Plus Nivolumab in Patients With Advanced Hepatocellular Carcinoma

NCT ID: NCT05178043

Last Updated: 2024-02-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2025-12-01

Brief Summary

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.

Conditions

Hepatocellular Carcinoma; HCC

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GT90001+Nivolumab

Group Type: EXPERIMENTAL

Nivolumab

Intervention Type: DRUG

Nivolumab 240mg to be administered as an intravenous (IV) infusion every 2 weeks (Q2W).

GT90001

Intervention Type: DRUG

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

Interventions

Nivolumab

Nivolumab 240mg to be administered as an intravenous (IV) infusion every 2 weeks (Q2W).

Intervention Type: DRUG

GT90001

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

Intervention Type: DRUG

Other Intervention Names

Opdivo, ONO-4538, BMS-936558, MDX1106; PF-03446962

Eligibility Criteria

Inclusion Criteria

• Subjects must have confirmed diagnosis of aHCC (locally advanced or metastatic hepatocellular carcinoma) by radiography, histology and/or cytology, not eligible for surgical and/or locoregional therapies; or progressive disease after surgical and/or locoregional therapies (fibrolamellar, sarcomatoid HCC and mixed hepatocellular / cholangiocarcinoma subtypes are not eligible);
• Have Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy;
• Have documented disease progression after or intolerance to first line treatment of immune checkpoint inhibitors(ICI)
• Child-Pugh score ≤ 6 (Child-Pugh A) score within 7 days of first dose of study drug;
• ECOG performance status: 0-1 within 7 days of first dose of study drug;
• Have a predicted life expectancy of greater than 3 months;
• Adequate hematologic and end-organ function functions of the important organs are confirmed.

Exclusion Criteria

• Presence of tumor thrombus involving main trunk of portal vein (Vp4), inferior vena cava, cardiac involvement of HCC;
• Subjects with untreated or incompletely treated varices with bleeding or high-risk for bleeding. Has had esophageal or gastric variceal bleeding within the last 6 months;
• History of encephalopathy;
• Has a known history of, or any evidence of central nervous system (CNS) metastases and/or carcinomatous meningitis;
• Had history of a solid organ or hematologic transplant;
• Has received locoregional therapy to liver (TACE, TAE, hepatic arterial infusion [HAI], radiation, radioembolization or ablation) within 4 weeks of start of study treatment.
• Had prior systemic TKI treatment prior to start of study treatment;
• Has received prior immune checkpoint inhibitors within 4 weeks of start of study treatment;
• Has received Nivolumab in the first-line systemic therapy:
• Active co-infection with:

1. Both hepatitis B and C as evidenced by positive HBV surface antigen or detectable HBV DNA and HCV RNA, OR

2. Hepatitis D infection in subjects with hepatitis B

• Has an active bacterial or fungal infection requiring systemic therapy within 7 days prior to study drug dosing;
• Has a known history of active tuberculosis (Bacillus Tuberculosis);
• Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture;
• Thrombotic or embolic events (except HCC tumor thrombus) within the past 6 months, such as cerebrovascular accident (including transient ischemic attacks), pulmonary embolism; If prior history of deep vein thrombosis (DVT) / (pulmonary embolism (PE), the subject needs to be on stable doses of anticoagulation with low molecular weight heparin or oral anticoagulant for at least two weeks;
• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
• Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis;
• Subjects with any other serious disease considered by the investigator not in the condition to enter into the trial;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suzhou Kintor Pharmaceutical Inc,

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

City of Hope National Medical Center

Duarte, California, United States

Los Angeles Hematology Oncology Medical Group

Los Angeles, California, United States

NYU Langone Health

New York, New York, United States

Renovatio Clinical

Houston, Texas, United States

Medical Oncology Associates

Spokane, Washington, United States

Countries

United States

Other Identifiers

GT90001-MR-1001

Identifier Type: -

Identifier Source: org_study_id