The Phase 1 Clinical Trial is designated as S101: Phase 1, Prospective, Multicenter, Open-Label, Single Arm Study of Safety and Initial Efficacy of CA4P in Combination with anti-PD1 (pembrolizumab) in Patients with Recurrent Metastatic Cutaneous or Uveal Melanoma.
CA4P has been evaluated in over 500 patients and treated in 17 clinical studies to date. These included multiple Phase 1 dose escalation studies, with dose cohorts up to 114 mg/m2, when used as monotherapy, 63 mg/m2 when used in combination with paclitaxel, and 63 mg/m2 when used in combination with bevacizumab. Based on the early Phase 1 studies, CA4P was further studied in larger Phase 2 studies including:
• Ovarian cancer - 60 mg/m2 CA4P in combination with 15 mg/kg bevacizumab (n=54) in combination with physician’s choice chemotherapy;
• Anaplastic thyroid cancer - 60 mg/m2 CA4P in combination with paclitaxel and carboplatin q3wk (n=51);
• Platinum resistant ovarian cancer - 63 mg/m2 CA4P in combination with paclitaxel and carboplatin q3wk (n=44);
• Non-small cell lung cancer - 60 mg/m2 CA4P in combination with bevacizumab and with paclitaxel and carboplatin q3wk (n=31).