USO 24130
A Phase II, multi-site, randomized, open-label clinical trial to evaluate the safety, efficacy, and pharmacokinetics of BNT327 at two dose levels in combination with chemotherapeutic agents as first- and second-line treatment in triple-negative breast cancer (BNT327-02)
Disease Types: Breast Cancer Research
Eligibility Requirements:
• Men and women w/ locally recurrent inoperable or metastatic TNBC
• 0-1 lines prior systemic therapy
• Systemic tx-naïve patients eligible if
• No prior systemic therapy in metastatic setting incl chemo,
immunotherapy
• ≥6 months must have elapsed b/t tx with curative intent and relapse
• Pts with 1L prior therapy eligible;
• If immunotherapy was given, minimum of two doses of PD-(L)1
inhibitor required
• Archival or fresh tissue sample required during screening
• At least 1 measurable lesion per RECIST v1.1
• Asymptomatic, stable cerebral and cerebellar metastases allowed
• Prior tx with PD(L)-1/VEGF bispecific antibody excluded
For more information on this trial CLICK HERE .
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