Clinical Trial 23697

• Overview

  Study Title:

  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-PI3KA Inhibitor, as a Single Agent and in Combination in Participants With Advanced Solid Tumors

  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.

  Objective:

  Primary Objectives Part 1: Dose Escalation - To determine the maximum tolerated dose (MTD) or the maximum administered dose (MAD) of VVD-159642 as a single agent Part 2: Safety Run-in and Dose Expansion - To further characterize the safety of VVD-159642 at the recommended dose(s) for expansion (RDE[s]) as a single agent in solid tumors - To evaluate the safety of VVD-159642 in combination with sotorasib in advanced non-small cell lung cancer (NSCLC) harboring a Kirsten rat sarcoma G12C (KRAS[G12C]) mutation - To evaluate the safety of VVD-159642 in combination with trametinib in advanced solid tumors harboring a rat sarcoma (RAS) alteration (KRAS, neuroblastoma RAS [NRAS], Harvey RAS [HRAS])

• Treatments

  Therapies:

  KRAS G12C; MEK Inhibitor; RAS-PIK3CA

  Medications:

  AMG 510 (Sotorasib); GSK1120212 (Trametinib); Olomorasib (); Sotorasib (); Trametinib (); VVD-159642 ()

• Inclusion 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.
  • Additional criteria may apply.

• Exclusion Criteria

  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).
  • Additional criteria may apply.

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