A Study of PM8002 Plus Nab-paclitaxel as First Line Therapy for TNBC

Sponsor
Biotheus Inc.
Study ID
NCT05918133
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • PM8002 — DRUG
    IV infusion
  • nab-paclitaxel — DRUG
    IV infusion

Study Details

Here, the investigators present the results from a Phase Ib/II study of PM8002 in combination with nab-paclitaxel in subjects with locally advanced or metastatic triple negative breast cancer without previous systematic treatment.

Key Dates

Start date
Jul 1, 2022
Status verified
Nov 2024
Primary completion
Oct 30, 2026
Completion
Oct 30, 2026

Study Design

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

Arms

  • Other: PM8002+nab-paclitaxel
    PM8002 at 20 mg/kg (Q2W) and nab-paclitaxel at 100 mg/m2 on the 1st, 8th, and 15th days of each cycle until unacceptable toxicity or disease progression were observed. Each cycle contains 28 days.

Primary Outcome Measure

Objective Response Rate [ Time Frame: Up to approximately 2 years ]

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