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Life sciences · Phase 1 Trial
ClinicalTrials.gov · November 2, 2026
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Phase 1 Trial.
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Registry record from ClinicalTrials.gov (NCT07910942). This is a study registration, not published results. Lead sponsor: Kanvas Biosciences. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 40 participants (ESTIMATED). Conditions: Non-Small Cell Lung Cancer. Interventions: BIOLOGICAL: KAN-001; BIOLOGICAL: Pembrolizumab. Primary outcome measures: Number of Participants With Treatment-Emergent Adverse Events , From the first dose of KAN-001 through approximately 30 days after the last dose, which may be up to approximately 2 years. Brief summary: 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.