GT90001 + Nivolumab for Liver Cancer

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Suzhou Kintor Pharmaceutical Inc,

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

This trial is for adults with advanced liver cancer (aHCC) who can't have or didn't improve with first-line immune treatments. They should be in relatively good health (Child-Pugh A, ECOG 0-1), not have had certain other cancers recently, no serious infections or organ transplants, and a life expectancy over 3 months.

Inclusion Criteria

Have a predicted life expectancy of greater than 3 months

My liver function is good, with a Child-Pugh score of 6 or less.

My liver cancer is at an advanced stage and cannot be treated with local therapies.

See 4 more

Exclusion Criteria

I received immune therapy less than 4 weeks ago.

I have another cancer that is getting worse or was treated in the last 3 years.

I have or had cancer spread to my brain or spinal cord.

See 14 more

Treatment Details

Interventions

GT90001 (Virus Therapy)
Nivolumab (Checkpoint Inhibitor)

Trial OverviewThe study tests GT90001 combined with Nivolumab in patients whose liver cancer has worsened after or couldn’t tolerate initial immune checkpoint inhibitors. It's an open-label phase II trial where both drugs are given by infusion every two weeks to a total of 105 participants.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: GT90001+NivolumabExperimental Treatment2 Interventions