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

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen ByWu Jiong

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Biotheus Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Inclusion Criteria

Voluntarily participate in clinical research; fully understand the study and voluntarily sign the informed consent; willing to follow and have the ability to complete all trial procedures;

Male or female, aged 18 to 75 years (including boundary value);

Unresectable locally advanced or metastatic breast cancer confirmed by histology or cytology, ER, PR, HER-2 are all negative. Negative ER and PR were defined as: IHCER < 1%, IHCPR < 1%. HER-2 negative is defined as: IHCHER-2 (-) or (1+), HER-2 (2+) must be tested by FISH and the result is negative.

+5 more

Participant Groups

1Treatment groups

Experimental Treatment

Group I: PM8002+nab-paclitaxelExperimental Treatment2 Interventions

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.