A Phase 2a Study with Safety Run-in to Evaluate the Safety Tolerability and Preliminary Efficacy of FF-10832 Monotherapy or in Combination with Pembrolizumab in Patients with Advanced Solid Tumors

Brief description of study

This is a medical study testing a drug called FF-10832 alone and with another medicine called pembrolizumab for patients with advanced solid tumors. First, patients will try both drugs together to make sure there minimum side effects. The study team will use FF-10832 at a certain dose with a fixed amount of pembrolizumab. If there are minimum to no side effects, the study team might try a lower dose for more patients. They'll keep checking and might use even smaller doses if needed and approved. Then, the study team will bring in more patients with two types of cancer: one in the bladder (urothelial cancer) and another in the lungs (non-small cell lung cancer). Each group of patients will be split into four smaller groups. These patients' cancers got worse after PD-1/PD-L1 therapy. Some patients will get just one drug, while others will get both, to see how safe and helpful FF-10832 is alone or with pembrolizumab. The study team might also include more types of cancer based on the first safety check.


Clinical Study Identifier: s23-01093
ClinicalTrials.gov Identifier: NCT05318573
Principal Investigator: Scot Niglio.
Other Investigators: Samantha VanMaanen, Jessica Wang, Elaine Shum, Salman Rafi Punekar, Laura Catherine Bauer, Sally Lau, Danny Perlaza, David Mendoza, Natalia Cherkassky, Vamsidhar Velcheti, Avital Benson, Melissa L Martinez, David R. Wise.


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