EICHORCondition: Advanced Solid Tumors · Sponsor: Vividion Therapeutics, Inc.
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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.
This description comes directly from the study's public registry record.
Vividion Clinical Trial Call Center · 858-345-9752 · clinicaltrials@vividion.com
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Always discuss trial participation with your own doctor first.
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).
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| 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 |
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Source record: clinicaltrials.gov/study/NCT06804824