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RECRUITING
NCT06804824
PHASE1

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.

View on ClinicalTrials.gov

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

Interventions

DRUG

VVD-159642

Oral capsules

DRUG

Sotorasib

Oral tablets

DRUG

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