Evaluating a new treatment for advanced solid tumors
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
PHASE1 · Vividion Therapeutics, Inc. · NCT06804824
This study is testing a new treatment called VVD-159642 for people with advanced solid tumors to see if it is safe and how well it works, both on its own and with other therapies.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vividion Therapeutics, Inc. (industry) |
| Drugs / interventions | trametinib |
| Locations | 9 sites (Grand Rapids, Michigan and 8 other locations) |
| Trial ID | NCT06804824 on ClinicalTrials.gov |
What this trial studies
This first-in-human study aims to assess the safety and tolerability of VVD-159642, a novel RAS-PI3Kα inhibitor, in patients with advanced solid tumors. The study will evaluate the pharmacokinetics and pharmacodynamics of VVD-159642 both as a standalone treatment and in combination with other therapies like sotorasib or trametinib. Participants will be closely monitored for any adverse effects and preliminary anti-tumor activity will also be assessed. The trial focuses on patients with specific types of solid tumors that have certain genetic alterations.
Who should consider this trial
Good fit: Ideal candidates include individuals with advanced solid tumors such as pancreatic ductal adenocarcinoma, colorectal cancer, or non-small cell lung cancer that have specific genetic alterations.
Not a fit: Patients with solid tumors that do not harbor the specified genetic alterations or those with early-stage tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that are difficult to treat.
How similar studies have performed: Other studies targeting RAS and PI3K pathways have shown promise, indicating potential for success with this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Grand Rapids, Michigan and 8 other locations
- START Mid West — Grand Rapids, Michigan, United States (RECRUITING)
- NEXT Austin — Austin, Texas, United States (RECRUITING)
- NEXT Dallas — Irving, Texas, United States (RECRUITING)
- START San Antonio — San Antonio, Texas, United States (RECRUITING)
- NEXT San Antonio — San Antonio, Texas, United States (RECRUITING)
- START Mountain — Ogden, Utah, United States (RECRUITING)
- NEXT Virginia — Fairfax, Virginia, United States (RECRUITING)
- Clinical Research South Australia (CRSA) — Adelaide, South Australia, Australia (RECRUITING)
- Linear Clinical — Nedlands, Western Australia, Australia (RECRUITING)
Study contacts
- Study coordinator: Vividion Clinical Trial Call Center
- Email: clinicaltrials@vividion.com
- Phone: 858-345-9752
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Advanced Solid Tumors, RAS, PI3K, KRAS, MEK, Phase I, solid tumors, KRAS G12C