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A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-159642 in Participants With Advanced Solid Tumors
Sponsor: Vividion Therapeutics, Inc.
Summary
A FIH study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of VVD-159642, a rat sarcoma viral oncogene-phosphatidylinositol 3-kinase alpha (RAS-PI3Kα) inhibitor, as a single agent and in combination with either sotorasib or trametinib in participants with advanced solid tumors.
Official title: A Phase 1/1b, Open-Label, Multicenter, First-in-Human Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-Tumor Activity of VVD-159642, a RAS-PI3Kα Inhibitor, as a Single Agent and in Combination in Participants With Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
220
Start Date
2025-02-25
Completion Date
2027-08-01
Last Updated
2026-03-18
Healthy Volunteers
No
Conditions
Interventions
VVD-159642
Oral capsules
Sotorasib
Oral tablets
Trametinib
Oral tablets
Locations (9)
START Mid West
Grand Rapids, Michigan, United States
NEXT Austin
Austin, Texas, United States
NEXT Dallas
Irving, Texas, United States
START San Antonio
San Antonio, Texas, United States
NEXT San Antonio
San Antonio, Texas, United States
START Mountain
Ogden, Utah, United States
NEXT Virginia
Fairfax, Virginia, United States
Clinical Research South Australia (CRSA)
Adelaide, South Australia, Australia
Linear Clinical
Nedlands, Western Australia, Australia