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An Open-label Phase 1b/2a Study of NT-I7 (Hyleukin-7) in Combination with Pembrolizumab in Subjects with Relapsed/Refractory Advanced Solid Tumors
This is a multicenter, open-label Phase 1b/2a study of NT-I7 in combination with pembrolizumab. The study consists of a dose escalation phase (Phase 1b) followed by a dose expansion phase (Phase 2a).
Primary Objectives Phase 1b: To determine the safety and tolerability, including determination of the Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RP2D) of NT-I7 in combination with pembrolizumab in subjects with advanced solid tumors. Phase 2a: To assess the preliminary anti-tumor activity of NT-I7 in combination with pembrolizumab in subjects with CPI treated R/R tumors (TNBC, NSCLC, SCLC), and CPI naïve R/R tumors (MSS-CRC and PC), based Overall Response Rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Secondary Objectives To further assess the anti-tumor activity of NT-I7 in combination with pembrolizumab in these patient populations based on Duration of Response (DoR), Disease Control Rate (DCR), Progression-Free Survival (PFS), and Overall Survival (OS). To evaluate immunogenicity of NT-I7 administered in combination with pembrolizumab in these patient populations.
NT-I7 (); Pembrolizumab (Keytruda)