PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic TNBC

Sponsor
Biotheus Inc.
Study ID
NCT06419621
Phase
PHASE3
Status
Recruiting
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Conditions

  • Triple Negative Breast Cancer(TNBC)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • PM8002 — DRUG
    PM8002 20 mg/kg via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle
  • Nab-Paclitaxel — DRUG
    Nab-Paclitaxel 100mg/m2 via IV infusion on Days 1, 8, and 15 of each 28-day cycle
  • Placebo — DRUG
    Placebo 20 mg/kg via IV infusion on Days 1 and 15 of each 28-day cycle

Study Details

This multicenter, randomized, double-blind study will evaluate the safety and efficacy of PM8002 in combination with Nab-Paclitaxel compared with placebo combined with Nab-Paclitaxel as first-line treatment in inoperable locally advanced/metastatic triple-negative breast cancer(TNBC)

Key Dates

Start date
Jun 11, 2024
Status verified
Mar 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2028

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PM8002 Plus Nab-Paclitaxel
    Patients will receive both PM8002 and Nab-Paclitaxel.
  • Placebo Comparator: Placebo Plus Nab-Paclitaxel
    Patients will receive both Placebo and Nab-Paclitaxel.

Primary Outcome Measure

Progression-Free Survival (PFS) assessed by Blinded Independent Review Committee (BIRC) [ Time Frame: Up to approximately 37 months from first patient in ]

Central Contacts