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Tests treatment safety and results for Advanced Solid Tumors
Official title A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-159642 in Participants With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06804824
What this study is testing
What is VVD-159642?
VVD-159642 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for advanced solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- For Part 1 Dose Escalation, the prospective participant must have histologically confirmed pancreatic ductal adenocarcinoma (PDAC), colorectal cancer...
- 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.
You likely can't join if
- 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...
- 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...
See the full eligibility 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...
- 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
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Grand Rapids, Michigan, United States
- Austin, Texas, United States
- Irving, Texas, United States
- San Antonio, Texas, United States
- Ogden, Utah, United States
- Fairfax, Virginia, United States
- Adelaide, South Australia, Australia
- Nedlands, Western Australia, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Grand Rapids, Michigan, United States; Austin, Texas, United States; Irving, Texas, United States; San Antonio, Texas, United States; Ogden, Utah, United States; Fairfax, Virginia, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.