A First-in-Human (FIH) Trial to Evaluate VVD-130037 in People With Advanced Solid Tumors
Phase 1
290
about 7.6 years
18+
8 sites in FL, MN, TN +2
What this study is about
This trial is testing the safety and how well VVD-130037 works in people with advanced solid tumors. The treatment will be given as a single agent or in combination with other medications like docetaxel, paclitaxel, or pembrolizumab.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Docetaxel
- 2.Take Paclitaxel
- 3.Take Pembrolizumab
- +1 more
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You are randomly assigned, but you will know your treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
docetaxel, paclitaxel (Taxane chemotherapy; stabilizes microtubules), pembrolizumab (Immune checkpoint inhibitor; blocks PD-1 to boost T-cell attack on cancer)
infusion, injection, intravenous
Primary: Part 1 (Dose Escalation): Incidence and Severity of Dose-limiting Toxicities (DLTs) During DLT Observation Period, Part 2 (Dose Expansion): Number of Participants With AEs, Serious Adverse Events (SAEs), and Clinical Laboratory Abnormalities
Secondary: Part 1 (Dose Escalation): Number of Participants With AEs, SAEs, and Clinical Laboratory Abnormalities, Part 2 (Dose Expansion): Disease Control Rate (DCR), Part 2 (Dose Expansion): Duration of Response (DOR), Part 2 (Dose Expansion): Overall Response Rate (ORR), Part 2 (Dose Expansion): Progression-free Survival (PFS), Parts 1 and 2 (Dose Escalation and Expansion): Apparent Terminal Half-life (T1/2) of VVD-130037, Parts 1 and 2 (Dose Escalation and Expansion): Area Under the Plasma Concentration-time Curve (AUC) of VVD-130037, Parts 1 and 2 (Dose Escalation and Expansion): Maximum Observed Concentration (Cmax) of VVD-130037