A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-159642 in Participants With Advanced Solid Tumors

Launched by VIVIDION THERAPEUTICS, INC. · Jan 27, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called VVD-159642 for people with advanced solid tumors, which are types of cancers that form in tissues like the pancreas, colon, or lungs. The main goal of the trial is to find out if this treatment is safe and well-tolerated by patients, as well as to see how it works when given alone or in combination with other drugs. The trial is currently looking for participants aged 65 to 74 who have specific types of cancer with certain genetic changes. To be eligible, participants should have tumors that cannot be surgically removed or have spread to other parts of the body, and they need to be able to take medications by mouth.

If you join this trial, you will receive the study treatment and have regular check-ups to monitor your health and how well the treatment is working. The study team will closely watch for any side effects or changes in your condition. It's important to know that certain health issues, like active brain tumors or heart problems, may prevent someone from participating in this trial. Overall, this study aims to explore new possibilities in cancer treatment and could be a way to access cutting-edge therapies.

Gender

ALL

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 (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).