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Active, not recruitingNCT05178043Updated Feb 22, 2024

GT90001 Plus Nivolumab in Patients With Advanced Hepatocellular Carcinoma

A Phase 2 interventional study of Nivolumab and GT90001 in Hepatocellular Carcinoma and HCC, sponsored by Suzhou Kintor Pharmaceutical Inc,. Active, not recruiting at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-22.

Sponsored by Suzhou Kintor Pharmaceutical Inc, · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 6 months ago, but the record still lists the study as active, not recruiting.
  • Registered 3 months after the study started (first participant enrolled Aug 2021, registered Nov 2021).
Phase
Phase 2
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • Hepatocellular Carcinoma
  • HCC
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.

This study's enrollment of 5 is below the median of 45 across 5,174 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Suzhou Kintor Pharmaceutical Inc, is the lead sponsor of 17 studies on the registry; 2 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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;
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    GT90001+Nivolumab

    Drug: Nivolumab · Drug: GT90001

Interventions

  • DrugNivolumab

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

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

  • DrugGT90001

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

    Also known as: PF-03446962

06

What researchers measure

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

    Time frame: Approximately 2 years

Secondary outcomes

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

    Time frame: Approximately 2 years

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

    Time frame: Approximately 2 years

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

    Time frame: Approximately 2 years

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

    Time frame: Approximately 2 years

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

    Time frame: Approximately 2 years

  6. ORR (confirmed) as evaluated by the investigator according to RECIST v1.1

    Time frame: Approximately 2 years

  7. DOR as evaluated by the investigator according to RECIST v1.1

    Time frame: Approximately 2 years

  8. PFS as evaluated by the investigator according to RECIST v1.1

    Time frame: Approximately 2 years

  9. TTR as evaluated by the investigator according to RECIST v1.1

    Time frame: Approximately 2 years

  10. TTP as evaluated by the investigator according to RECIST v1.1

    Time frame: Approximately 2 years

  11. DCR as evaluated by the investigator according to RECIST v1.1

    Time frame: Approximately 2 years

  12. ORR (confirmed) as evaluated by an IRC according to HCC mRECIST

    Time frame: Approximately 2 years

  13. DOR as evaluated by an IRC according to HCC mRECIST

    Time frame: Approximately 2 years

  14. PFS as evaluated by an IRC according to HCC mRECIST

    Time frame: Approximately 2 years

  15. TTR as evaluated by an IRC according to HCC mRECIST

    Time frame: Approximately 2 years

  16. TTP as evaluated by an IRC according to HCC mRECIST

    Time frame: Approximately 2 years

  17. DCR as evaluated by an IRC according to HCC mRECIST

    Time frame: Approximately 2 years

  18. ORR (confirmed) as evaluated by the investigator according to HCC mRECIST

    Time frame: Approximately 2 years

  19. DOR as evaluated by the investigator according to HCC mRECIST

    Time frame: Approximately 2 years

  20. PFS as evaluated by the investigator according to HCC mRECIST

    Time frame: Approximately 2 years

  21. TTR as evaluated by the investigator according to HCC mRECIST

    Time frame: Approximately 2 years

  22. TTP as evaluated by the investigator according to HCC mRECIST

    Time frame: Approximately 2 years

  23. DCR as evaluated by the investigator according to HCC mRECIST

    Time frame: Approximately 2 years

  24. Overall survival (OS)

    Time frame: Approximately 3 years

  25. Safety and tolerability (any Advense Events (AEs), Severe AEs , immune-related AEs (irAEs), treatment-related AEs, abnormal laboratory values, etc.

    Time frame: Approximately 2 years

  26. Presence of Anti-Drug Antibodies (ADAs) to GT90001 and Nivolumab during the study relative to the presence of ADAs at baseline

    Time frame: Approximately 2 years

07

Study locations

5 sites
  • City of Hope National Medical Center
    Duarte, California 91010, United States
  • Los Angeles Hematology Oncology Medical Group
    Los Angeles, California 90017, United States
  • NYU Langone Health
    New York, New York 10016, United States
  • Renovatio Clinical
    Houston, Texas 77056, United States
  • Medical Oncology Associates
    Spokane, Washington 99208, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05178043
Lead sponsor
Suzhou Kintor Pharmaceutical Inc,
Responsible party
Sponsor
First posted
Jan 5, 2022
Start date
Aug 1, 2021
Primary completion
Apr 1, 2025 (estimated)
Completion
Dec 1, 2025 (estimated)
Last update
Feb 22, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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