Kanvas Biosciences
The goal of this Phase 1 clinical trial is to learn whether KAN-001, an investigational live biotherapeutic product, can be safely given with pembrolizumab, with or without chemotherapy, to adults with PD-L1-positive, inoperable or metastatic non-small cell lung cancer. The main questions it aims to answer are: * What side effects occur when KAN-001 is given with pembrolizumab, with or without chemotherapy? * Can the microbial strains contained in KAN-001 be detected in participants' stool after treatment? Participants will: * Complete a bowel preparation before receiving the first dose of KAN-001. * Take a loading dose of KAN-001, followed by maintenance doses every 3 weeks. * Receive pembrolizumab every 3 weeks. Some participants will also receive chemotherapy. * Provide blood, stool, and stool-wipe samples and complete a gastrointestinal symptom diary. * Undergo imaging scans and other study assessments to monitor their cancer, health, and safety.
Inclusion Criteria: * The participant is willing and able to provide written informed consent for the trial. * Histologically/cytologically confirmed diagnosis of NSCLC. * Have inoperable or metastatic disease that is measurable based on RECIST v1.1. * Not a candidate for any molecular / biomarker directed targeted therapy approved in the country where the participant is enrolled for the treatment of advanced NSCLC, including but not limited to therapies targeting epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), Proto-oncogene tyrosine-protein kinase ROS1 (ROS1), B-R…
Each dose of KAN-001 contains a defined consortium of commensal bacterial strains for oral administration.
Each dose of pembrolizumab contains a monoclonal antibody that blocks the programmed cell death protein 1 (PD-1) pathway and is administered by intravenous infusion.