A Phase 1, Open-label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-tumor Activity of VVD-130037, a Kelch-like ECH Associated Protein 1 (KEAP1) Activator, in Participants With Advanced Solid Tumors
Vividion Therapeutics, Inc.
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugVVD-130037
Oral tablets
- DrugDocetaxel
IV infusion
- DrugPaclitaxel
IV infusion
- DrugPembrolizumab
IV infusion
Locations (26)
- Mayo Clinic JacksonvilleJacksonville, Florida
- Florida Cancer SpecialistsSarasota, Florida
- Moffitt Cancer CenterTampa, Florida
- Mayo Clinic RochesterRochester, Minnesota
- Sarah Cannon Research InstituteNashville, Tennessee
- MDACCHouston, Texas