A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-159642 in Participants With Advanced Solid Tumors
NCT06804824 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 220
Last updated 2026-03-18
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.
Conditions
Interventions
- DRUG
-
VVD-159642
Oral capsules
- DRUG
-
Sotorasib
Oral tablets
- DRUG
-
Trametinib
Oral tablets
Sponsors & Collaborators
-
Vividion Therapeutics, Inc.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-25
- Primary Completion
- 2027-08-01
- Completion
- 2027-08-01
- FDA Drug
- Yes
Countries
- United States
- Australia
Study Locations
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