A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130850 in Participant… (NCT06188208) | Clinical Trial Compass
TerminatedPhase 1
A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130850 in Participants With Advanced Solid and Hematologic Tumors
Stopped: The study has ended
United States, Australia, Spain132 participantsStarted 2024-01-05
Plain-language summary
A FIH study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VVD-130850, as single agent and in combination with checkpoint inhibition, in participants with advanced solid and hematologic tumors.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Histologically or cytologically confirmed metastatic or unresectable solid tumor or advanced non-Hodgkin's lymphoma (NHL).
. Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
. Adequate organ and bone marrow function as defined in the protocol.
. For Combination Therapy Expansion:
. Measurable disease by RECIST version 1.1 as assessed by the Investigator.
Exclusion criteria
. Have a diagnosis of immunodeficiency or are receiving systematic steroid therapy or any other form of immunosuppressive therapy.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dose Escalation: Incidence and Severity of Dose-limiting Toxicities (DLTs) During DLT Observation Period
Timeframe: From Day 1 to Day 21 of Cycle 1 [cycle length=21 days]
2
Dose Expansion: Number of Participants with AEs and Serious Adverse Events (SAEs)
Timeframe: Up to approximately 4 years
3
Dose Expansion: Number of Participants with Clinically Significant Changes in Vital Signs
Timeframe: Up to approximately 4 years
4
Dose Expansion: Number of Participants with Clinically Significant Changes in Laboratory Evaluations