Phase 1: testing VVD-159642 for Advanced Solid Tumors
A FIH study to measure 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 registry: https://clinicaltrials.gov/study/NCT06804824 · Vividion Therapeutics, Inc. · enrollment listed as 220
What this phase means
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are VVD-159642, Sotorasib, or Trametinib. The registry lists allocation as randomized. A FIH study to measure 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.
They plan to enroll about 220 people at 9 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
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
Interventions: VVD-159642, Sotorasib, Trametinib
Primary outcome (registry wording): Part 1: Incidence and Severity of Dose-limiting Toxicities (DLTs)
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- 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
Who the registry excludes
- 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)
Public study contact (from the registry)
Vividion Clinical Trial Call Center
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
9 listed- 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)
+ 2 sites outside the US on the same record
FAQ about this NCT record
Is NCT06804824 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06804824?
Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06804824?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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