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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 · View on ClinicalTrials.gov ↗

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.

Conditions Studied

Interventions

  • DRUG Trametinib
  • DRUG Sotorasib
  • DRUG VVD-159642

Study Locations (9)

Texas

  • NEXT Austin — Austin
  • NEXT Dallas — Irving
  • START San Antonio — San Antonio
  • NEXT San Antonio — San Antonio

Michigan

  • START Mid West — Grand Rapids

Utah

  • START Mountain — Ogden

Virginia

  • NEXT Virginia — Fairfax

South Australia

  • Clinical Research South Australia (CRSA) — Adelaide

Western Australia

  • Linear Clinical — Nedlands

Trial Details

FieldValue
Enrollment Target 220 participants
Start Date 2025-02-25
Est. Completion 2027-08-01
Phase Phase 1

Sponsor

Vividion Therapeutics

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06804824

The ClinicalTrials.gov registry entry for NCT06804824 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 220 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vividion Therapeutics, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Advanced Solid Tumors appearing as the primary indexed condition, and to 3 interventions — of which Trametinib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06804824 reports 9 study locations spanning 6 distinct geographic areas — top geographies include Texas, Michigan, Utah. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06804824 about?

NCT06804824 is a clinical study titled "A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-159642 in Participants With Advanced Solid Tumors". 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 tra...

What is the current status of trial NCT06804824?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 220 participants. The study started on 2025-02-25. Estimated completion is 2027-08-01.

What conditions does trial NCT06804824 study?

This clinical trial studies the following conditions: Advanced Solid Tumors. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06804824?

The interventions under investigation include: Trametinib (DRUG), Sotorasib (DRUG), VVD-159642 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06804824?

This trial is sponsored by Vividion Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06804824 being conducted?

This trial has 9 study locations across Michigan, Texas, Utah, Virginia, South Australia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial