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Hepatocellular CarcinomaPhase 2NCT05178043

GT90001 Plus Nivolumab in Patients With Advanced Hepatocellular Carcinoma

A Phase 2 study testing Nivolumab and GT90001 in people with Hepatocellular Carcinoma and HCC, run by Suzhou Kintor Pharmaceutical Inc, at 5 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma, HCC
What is being tested?
Nivolumab and GT90001
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
5 sitesUnited States
Study dates
1 Aug 2021to 1 Dec 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 19Show fewer
  • 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;
  • 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;

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • City of Hope National Medical Center

    Duarte, California, 91010

  • Renovatio Clinical

    Houston, Texas, 77056

  • Los Angeles Hematology Oncology Medical Group

    Los Angeles, California, 90017

  • NYU Langone Health

    New York, New York, 10016

  • Medical Oncology Associates

    Spokane, Washington, 99208

Other trials in United States

About this study

Official title: A Phase II Study to Evaluate the Efficacy and Safety of GT90001 in Combination With Nivolumab as a Second-line Treatment in Subjects With Advanced Hepatocellular Carcinoma

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.

Read more

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.
Being tested
Nivolumab, GT90001
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NivolumabDrug

    Also called Opdivo, ONO-4538, BMS-936558, MDX1106

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

  • GT90001Drug

    Also called PF-03446962

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

Study groups in NCT05178043
Study groupRoleWhat they receive
GT90001+NivolumabExperimentalNot described
Receives: Drug: Nivolumab; Drug: GT90001

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Approximately 2 years

Secondary outcomes (26)

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

    Measured: Approximately 2 years

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

    Measured: Approximately 2 years

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

    Measured: Approximately 2 years

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

    Measured: Approximately 2 years

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

    Measured: Approximately 2 years

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

    Measured: Approximately 2 years

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

    Measured: Approximately 2 years

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

    Measured: Approximately 2 years

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

    Measured: Approximately 2 years

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

    Measured: Approximately 2 years

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

    Measured: Approximately 2 years

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

    Measured: Approximately 2 years

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

    Measured: Approximately 2 years

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

    Measured: Approximately 2 years

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

    Measured: Approximately 2 years

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

    Measured: Approximately 2 years

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

    Measured: Approximately 2 years

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

    Measured: Approximately 2 years

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

    Measured: Approximately 2 years

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

    Measured: Approximately 2 years

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

    Measured: Approximately 2 years

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

    Measured: Approximately 2 years

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

    Measured: Approximately 2 years

  24. Overall survival (OS)

    Measured: Approximately 3 years

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

    Measured: 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

    Measured: Approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2022
  2. Study start1 Aug 2021
  3. Primary completion1 Apr 2025 (estimated)
  4. Study completion1 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05178043
Sponsor's protocol ID
GT90001-MR-1001
Status last verified
Feb 2024
First submitted
25 Nov 2021
Last updated
22 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab and GT90001 in people with Hepatocellular Carcinoma and HCC, run by Suzhou Kintor Pharmaceutical Inc, at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Objective Response Rate (ORR) (confirmed) as evaluated by an Independent Review Committee (IRC) according to RECIST v1.1 (time frame: Approximately 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05178043.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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