A Study to Evaluate of PM8002 Combined With PM1009 in Patients With First-line HCC

Sponsor
Biotheus Inc.
Study ID
NCT06584071
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • PM8002 — DRUG
    PM8002 via IV infusion, Q3W
  • PM1009 — DRUG
    PM8002 via IV infusion, Q3W
  • atezolizumab — DRUG
    atezolizumab,1200mg, via IV infusion, Q3W
  • bevacizumab — DRUG
    bevacizumab,15mg/kg, via IV infusion, Q3W

Study Details

This study to evaluate the preliminary efficacy, safety and pharmacokinetics of PM8002 combined with PM1009 in Patients with first-line Hepatocellular Carcinoma.

Key Dates

Start date
Dec 31, 2024
Status verified
Dec 2024
Primary completion
Oct 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
140 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1- combination treatment
    Combination regimen：PM8002 combined with PM1009. The drugs are administered on the first day every 3 weeks (Q3W), until disease progression or intolerable toxicity or patient withdrawal or study discontinuation(Whichever occurs first).
  • Experimental: Cohort 2- combination treatment
    Combination regimen：PM8002 combined with PM1009(low dose). The drugs are administered on the first day every 3 weeks (Q3W), until disease progression or intolerable toxicity or patient withdrawal or study discontinuation(Whichever occurs first).
  • Experimental: Cohort 3- monotherapy
    PM8002 administered on the first day every 3 weeks (Q3W), until disease progression or intolerable toxicity or patient withdrawal or study discontinuation(Whichever occurs first).
  • Active Comparator: Cohort 4
    Combination regimen：atezolizumab combined with bevacizumab. The drugs are administered on the first day every 3 weeks (Q3W), until disease progression or intolerable toxicity or patient withdrawal or study discontinuation(Whichever occurs first).

Primary Outcome Measure

Objective response rate(ORR) [ Time Frame: Up to approximately 2 years ]

Central Contacts

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