GT90001 Plus Nivolumab in Patients With Advanced Hepatocellular Carcinoma

NCT05178043 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: GT90001-MR-1001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 5

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

Outcome Measures

Primary Outcomes (1)

• The Objective Response Rate (ORR) (confirmed) as evaluated by an Independent Review Committee (IRC) according to RECIST v1.1

  ORR is defined as the proportion of participants with best overall response of confirmed complete response (CR) or partial response (PR). RECIST: Response Evaluation Criteria in Solid Tumors

  Approximately 2 years

Secondary Outcomes (26)

• Duration OF Response (DOR) as evaluated by an IRC according to RECIST v1.1

  Approximately 2 years

• Progression Free Survival (PFS) as evaluated by an IRC according to RECIST v1.1

  Approximately 2 years

• Time To Response (TTR) as evaluated by an IRC according to RECIST v1.1

  Approximately 2 years

• Time to Progression (TTP) as evaluated by an IRC according to RECIST v1.1

  Approximately 2 years

• Disease Control Rate (DCR) as evaluated by an IRC according to RECIST v1.1

  Approximately 2 years

Study Arms (1)

GT90001+Nivolumab

EXPERIMENTAL

Drug: Nivolumab; Drug: GT90001

Interventions

Nivolumab DRUG

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

Also known as: Opdivo, ONO-4538, BMS-936558, MDX1106

GT90001+Nivolumab

GT90001 DRUG

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

Also known as: PF-03446962

GT90001+Nivolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Both hepatitis B and C as evidenced by positive HBV surface antigen or detectable HBV DNA and HCV RNA, OR
• 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;

Sponsors & Collaborators

• Suzhou Kintor Pharmaceutical Inc,: lead

Study Sites (5)

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

Los Angeles Hematology Oncology Medical Group

Los Angeles, California, 90017, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Renovatio Clinical

Houston, Texas, 77056, United States

Location

Medical Oncology Associates

Spokane, Washington, 99208, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Nivolumab; ascrinvacumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: January 5, 2022
• Study Start: August 1, 2021
• Primary Completion: April 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 22, 2024

Record last verified: 2024-02

Locations

US (5)