A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130037 in Participants With Advanced Solid Tumors
Trial Parameters
Brief Summary
A FIH dose escalation and dose expansion study to evaluate VVD-130037 in participants with advanced solid tumors as a single agent, and in combination with docetaxel, paclitaxel, or pembrolizumab.
Eligibility Criteria
Key Inclusion Criteria for Parts 1 and 2: * Histologically or cytologically confirmed metastatic or unresectable solid tumor. * Measurable disease by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as assessed by the Investigator. * Have progressed on or after all prior standard-of-care therapies for metastatic disease. * Eastern Cooperative Oncology Group (ECOG) performance status ≤1. * Adequate organ and marrow function as defined in the protocol. Additional Key Inclusion Criteria for Part 2: * Participants with squamous non-small cell lung cancer (sqNSCLC) with or without nuclear factor erythroid 2-related factor 2 (NRF2 \[NFE2L2\]) and/or cullin 3 (CUL3) mutations. * Participants with advanced sqNSCLC must be refractory to or have progressed on or after a platinum-based doublet regimen and an immune checkpoint inhibitor. * Participants with advanced head and neck squamous cell carcinoma (HNSCC) must have received prior treatment with platinum-based chemothera