Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05178043
Other study ID # GT90001-MR-1001
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date August 1, 2021
Est. completion date December 1, 2025

Study information

Verified date February 2024
Source Suzhou Kintor Pharmaceutical Inc,
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 5
Est. completion date December 1, 2025
Est. primary completion date April 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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;

Study Design


Intervention

Drug:
Nivolumab
Nivolumab 240mg to be administered as an intravenous (IV) infusion every 2 weeks (Q2W).
GT90001
GT90001 7mg/kg to be administered as an intravenous infusion every 2 weeks (Q2W) after Nivolumab infusion.

Locations

Country Name City State
United States City of Hope National Medical Center Duarte California
United States Renovatio Clinical Houston Texas
United States Los Angeles Hematology Oncology Medical Group Los Angeles California
United States NYU Langone Health New York New York
United States Medical Oncology Associates Spokane Washington

Sponsors (1)

Lead Sponsor Collaborator
Suzhou Kintor Pharmaceutical Inc,

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Duration OF Response (DOR) as evaluated by an IRC according to RECIST v1.1 Approximately 2 years
Secondary Progression Free Survival (PFS) as evaluated by an IRC according to RECIST v1.1 Approximately 2 years
Secondary Time To Response (TTR) as evaluated by an IRC according to RECIST v1.1 Approximately 2 years
Secondary Time to Progression (TTP) as evaluated by an IRC according to RECIST v1.1 Approximately 2 years
Secondary Disease Control Rate (DCR) as evaluated by an IRC according to RECIST v1.1 Approximately 2 years
Secondary ORR (confirmed) as evaluated by the investigator according to RECIST v1.1 Approximately 2 years
Secondary DOR as evaluated by the investigator according to RECIST v1.1 Approximately 2 years
Secondary PFS as evaluated by the investigator according to RECIST v1.1 Approximately 2 years
Secondary TTR as evaluated by the investigator according to RECIST v1.1 Approximately 2 years
Secondary TTP as evaluated by the investigator according to RECIST v1.1 Approximately 2 years
Secondary DCR as evaluated by the investigator according to RECIST v1.1 Approximately 2 years
Secondary ORR (confirmed) as evaluated by an IRC according to HCC mRECIST Approximately 2 years
Secondary DOR as evaluated by an IRC according to HCC mRECIST Approximately 2 years
Secondary PFS as evaluated by an IRC according to HCC mRECIST Approximately 2 years
Secondary TTR as evaluated by an IRC according to HCC mRECIST Approximately 2 years
Secondary TTP as evaluated by an IRC according to HCC mRECIST Approximately 2 years
Secondary DCR as evaluated by an IRC according to HCC mRECIST Approximately 2 years
Secondary ORR (confirmed) as evaluated by the investigator according to HCC mRECIST Approximately 2 years
Secondary DOR as evaluated by the investigator according to HCC mRECIST Approximately 2 years
Secondary PFS as evaluated by the investigator according to HCC mRECIST Approximately 2 years
Secondary TTR as evaluated by the investigator according to HCC mRECIST Approximately 2 years
Secondary TTP as evaluated by the investigator according to HCC mRECIST Approximately 2 years
Secondary DCR as evaluated by the investigator according to HCC mRECIST Approximately 2 years
Secondary Overall survival (OS) Approximately 3 years
Secondary Safety and tolerability (any Advense Events (AEs), Severe AEs , immune-related AEs (irAEs), treatment-related AEs, abnormal laboratory values, etc. Approximately 2 years
Secondary Presence of Anti-Drug Antibodies (ADAs) to GT90001 and Nivolumab during the study relative to the presence of ADAs at baseline Approximately 2 years
See also
  Status Clinical Trial Phase
Recruiting NCT04209491 - Interest of the Intervention of a Nurse Coordinator in Complex Care Pathway
Completed NCT03963206 - Cabozantinib toLERANCE Study in HepatoCellular Carcinoma (CLERANCE) Phase 4
Completed NCT03268499 - TACE Emulsion Versus Suspension Phase 2
Recruiting NCT05263830 - Glypican-3 as a Prognostic Factor in Patients With Hepatocellular Carcinoma Treated by Immunotherapy
Recruiting NCT05044676 - Immune Cells as a New Biomarker of Response in Patients Treated by Immunotherapy for Advanced Hepatocellular Carcinoma
Recruiting NCT05095519 - Hepatocellular Carcinoma Imaging Using PSMA PET/CT Phase 2
Recruiting NCT05497531 - Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers N/A
Completed NCT05068193 - A Clinical Trial to Compare the Pharmacokinetics and Bioequivalence of "BR2008" With "BR2008-1" in Healthy Volunteers Phase 1
Active, not recruiting NCT03781934 - A Study to Evaluate MIV-818 in Patients With Liver Cancer Manifestations Phase 1/Phase 2
Terminated NCT03655613 - APL-501 or Nivolumab in Combination With APL-101 in Locally Advanced or Metastatic HCC and RCC Phase 1/Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT04242199 - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors Phase 1
Completed NCT04401800 - Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib for Hepatocellular Carcinoma Phase 2
Withdrawn NCT05418387 - A Social Support Intervention to Improve Treatment Among Hispanic Kidney and Liver Cancer Patients in Arizona N/A
Active, not recruiting NCT04039607 - A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma Phase 3
Terminated NCT03970616 - A Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma Phase 1/Phase 2
Recruiting NCT06239155 - A Phase I/II Study of AST-3424 in Subjects With Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT04118114 - Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors Phase 2
Recruiting NCT03642561 - Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE Phase 2/Phase 3
Completed NCT03222076 - Nivolumab With or Without Ipilimumab in Treating Patients With Resectable Liver Cancer Phase 2