First-in-Human, Phase 1/1b, Open-label, Multicenter Study of Bifunctional EGFR/TGF_ Fusion Protein BCA101 Alone and in Combination with Pembrolizumab in Patients With EGFR-Driven Advanced Solid Tumors
This is a Phase 1/1b, open-label study, which consists of dose escalation parts (Part A) followed by expansion cohorts (Part B) for both single agent BCA101 and combination BCA101 plus pembrolizumab. The study population in dose escalation (Part A) of single agent BCA101 consists of subjects with EGFR-driven advanced solid tumors refractory to standard of care or for whom no standard of care is available. Dose escalation (Part A) of combination BCA101 and pembrolizumab consists of subjects with either Squamous Cell Carcinoma of the Head and Neck (HNSCC) or Squamous Cell Carcinoma of the Anal Canal (SCCAC) whose tumors are refractory to standard of care or for whom no standard of care is available. Once the maximum tolerated dose (MTD) / recommended dose (RD) of single agent BCA101 is determined, the study will continue with expansion cohorts (Part B) with select tumor types. Expansion cohorts for single agent BCA101 will include cutaneous squamous cell carcinoma. Planned expansion cohorts for the combination of BCA101 and pembrolizumab include: 1) HNSCC and 2) SCCAC.
Primary Objective: * To characterize the safety and tolerability of single agent BCA101 and BCA101 in combination with pembrolizumab or encorafenib and to identify recommended doses and indications for future studies by assessing the incidence and severity of adverse events (AEs), serious adverse events (SAEs), dose adjustments, as well as laboratory values, vital signs, and electrocardiograms (ECGs). Secondary Objectives: * To evaluate preliminary activity of single agent BCA101 and BCA101 in combination with pembrolizumab or encorafenib by assessing the clinical benefit rate (CBR) and objective response rate (ORR). * To characterize BCA101 with assessment of pharmacokinetics (PK), immunogenicity, and pharmacodynamic profiles of each arm by assessing drug concentration within serum/plasma, anti-drug antibodies (ADAs), and the changes from baseline pharmacodynamic markers in peripheral blood mononuclear cells and tumor tissue.
BCA101 (); Pembrolizumab (Keytruda)
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