Triple Negative Breast Cancer Clinical Trial
Official title:
An Open Label, Phase Ib/II Trial to Study the Safety, Tolerability and Antitumor Activity of X4P-001 in Combination With Toripalimab in Patients With Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)
Objectives Phase 1b Primary Objectives: To evaluate the safety and tolerability of X4P-001 combined with toriplimab in patients with locally advanced or metastatic TNBC Secondary Objectives: 1. To characterize the pharmacokinetics (PK) profile of X4P-001 alone or combined with toriplimab 2. To characterize the antitumor activity of X4P-001 in combination with toriplimab in patients with locally advanced or metastatic TNBC(according to RECIST 1.1) 3. To characterize the overall survival of X4P-001 in combination with toriplimab in patients with locally advanced or metastatic TNBC 4. To characterize the immunogenicity of toriplimab when administrated in combination with X4P-001
Exploratory Objectives: 1. To explore selected biomarkers in peripheral blood and tumor samples that potentially correlate with clinical response to X4P-001 and toriplimab combination treatment 2. To characterize the antitumor activity of X4P-001 in combination with toriplimab in patients with locally advanced or metastatic TNBC(according to iRECIST 1.1) ;
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