A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-159642 in Participants With Advanced Solid Tumors
This is an early-stage study testing a new cancer drug called VVD-159642 in people with advanced solid tumors. The drug works by blocking proteins that help cancer cells grow, and researchers will test it both alone and combined with other approved cancer treatments to see if it is safe and effective.
Key Objective: This trial is testing whether VVD-159642 can slow or stop the growth of advanced cancers while being safe enough for patients to tolerate.
Who to Consider: People with advanced solid tumors who have exhausted standard treatment options or whose tumors have specific genetic markers related to RAS or PI3K pathways may want to consider enrolling.
Trial Parameters
Brief 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 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 (