Study Investigating the Association of NP137 With Atezolizumab-Bevacizumab Combination in First Line in Unresectable HCC

Sponsor
University Hospital, Grenoble
Study ID
NCT05546879
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NP137 — DRUG
    NP137 at 9 or 14 mg/kg IV will be administered every 21 days.
  • Atezolizumab — DRUG
    Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-days cycle
  • Bevacizumab — DRUG
    Bevacizumab will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle

Study Details

The study will assess the safety of the association of NP137 with the standard of care Atezolizumab-Bevacizumab in first line setting in patients with unresectable hepatocellular carcinoma. The study drug which is tested is the NP137 in association with Atezolizumab-Bevacizumab to allow a better tumor response as well as better survival outcomes with an acceptable safety.

Key Dates

Start date
Mar 15, 2023
Status verified
May 2026
Primary completion
Mar 19, 2026
Completion
Mar 19, 2029

Study Design

Enrollment
43 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental
    NP137+Atezolizumab-Bevacizumab

Primary Outcome Measure

Percentage Proportion of patients experiencing adverse events [ Time Frame: At 36 months ]

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