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Clinical Trials in the USA / NCT06804824
Recruiting Phase 1

A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-159642 in Participants With Advanced Solid Tumors

NCT06804824 · tracked via the Priya Life Science USA tracker
Sponsor
Vividion Therapeutics, Inc.
Phase
Phase 1
Started
2025-02-25
Last updated
2026-03-18

Condition(s) studied

Advanced Solid Tumors

Investigational drug(s) / intervention(s)

VVD-159642Sotorasib →Trametinib →

VVD-159642: Oral capsules

Sotorasib: Oral tablets

Trametinib: Oral tablets

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Key Inclusion Criteria: * For Part 1 Dose Escalation, the prospective participant must have histologically confirmed pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC), or any solid tumor that harbors a rat sarcoma viral oncogene (RAS) alteration \[Kirsten rat sarcoma viral oncogene homolog (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), Harvey rat sarcoma viral oncogene homolog (HRAS)\] as per local /historical testing; any solid tumor that harbors an epidermal growth factor receptor (EGFR) alteration as per local/historical testing; or human epidermal growth factor receptor 2 (HER2) overexpression (immunohistochemistry \[IHC\] 3+ or IHC 2+/fluorescence in situ hybridization \[FISH\] positive) as per local/historical testing. * Have histologically or cytologically confirmed metastatic or unresectable solid tumors. * Measurable disease by RECIST version 1.1 as assessed by the investigator. * Eastern Cooperative Oncology Group (ECOG) performance status ≤1. * Adequate bone marrow, kidney, and liver function as defined in the protocol. * Able to take oral medications. Key Exclusion Criteria: * Active central nervous system (CNS) malignancies. * History of cardiac diseases as defined in detail in the protocol. * Uncontrolled arterial hypertension despite optimal medical management (per investigator's opinion). * History of inflammatory bowel disease or any malabsorption syndrome or any conditions that would interfere with enteral absorption and/or may interfere with the conduct of the study. * Active hepatitis B infection \[positive for hepatitis B surface antigen and Hepatitis B virus deoxyribonucleic acid (DNA)\]. * Active hepatitis C infection (positive anti-hepatitis C virus \[HCV\] antibody and quantitative HCV ribonucleic acid (RNA) results greater than the lower limits of detection of the assay).

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
START Mid West Grand Rapids Michigan Recruiting
NEXT Austin Austin Texas Recruiting
NEXT Dallas Irving Texas Recruiting
START San Antonio San Antonio Texas Recruiting
NEXT San Antonio San Antonio Texas Recruiting
START Mountain Ogden Utah Recruiting
NEXT Virginia Fairfax Virginia Recruiting
Clinical Research South Australia (CRSA) Adelaide South Australia Recruiting
Linear Clinical Nedlands Western Australia Recruiting

On this site

📄 Lumakras (sotorasib) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06804824 on ClinicalTrials.gov ↗ ← All trials in the USA