RBN-2397 in Combination With Pembrolizumab in Patients With SCCL

This is an open label, multicenter Phase 1b/2 single arm study that will evaluate the safety and antitumor activity of RBN-2397 in combination with pembrolizumab in patients with confirmed diagnosis of advanced squamous cell carcinoma of the lung who have received prior therapy. The study consists of a Phase 1b Safety Run in and Phase 2. During the Phase 1b Safety Run-in, approximately 10 patients will be enrolled in a 3+3 fashion and treated with continuous oral dosing with RBN-2397 twice daily (BID) in combination with the fixed approved dose of intravenous (IV) pembrolizumab every 3 weeks \[Q3W\]) to establish RP2D of RBN-2397 in combination with pembrolizumab. During Phase 2, approximately 40 patients will be treated with continuous oral dosing with the RP2D of RBN-2397 BID in combination with the fixed approved dose of IV pembrolizumab. In both the Phase 1b Safety Run in and Phase 2, a treatment cycle is defined as 21 days. On Day 1 of each treatment cycle, RBN-2397 will be administered orally and followed by IV infusion of pembrolizumab at the fixed approved dose according to the approved local product label. During the remaining days of the 21-day treatment cycle, only RBN-2397 BID will be administered. Treatment cycles will continue until disease progression, unacceptable treatment-related toxicity, or withdrawal of consent