OncoMatch/Clinical Trials/NCT06419621

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

Is NCT06419621 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including PM8002 and Nab-Paclitaxel for triple negative breast cancer(tnbc).

Phase 3RecruitingBiotheus Inc.NCT06419621Data as of May 2026

Treatment: PM8002 · Nab-Paclitaxel — 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)

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Extracted eligibility criteria

Cancer type

Triple-Negative Breast Cancer

Breast Carcinoma

Biomarker criteria

Required: HER2 (ERBB2) negative (negative)

Required: ESR1 negative (negative)

Required: PR (PGR) negative (negative)

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)

Max 0 prior lines

Cannot have received: immune checkpoint agonist

Previous treatment with immune checkpoint agonists (such as CD137 agonists)

Cannot have received: immune checkpoint inhibitor

immune checkpoint inhibitors (such as CTLA-4, PD-1, PD-L1, LAG3 monoclonal antibody, etc.)

Cannot have received: anti-vascular endothelial growth factor (VEGF) target drugs

anti-vascular endothelial growth factor (VEGF) target drugs

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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