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VVD-130037 for Advanced Cancers
Phase 1
Recruiting
Research Sponsored by Vividion Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to end of treatment (up to approximately 4 years)
Awards & highlights
Study Summary
This trial will study a new drug to see if it's safe & effective for people with advanced cancers.
Who is the study for?
This trial is for adults with advanced solid tumors who have tried all standard treatments without success. They must be relatively active (ECOG ≤1), have a confirmed diagnosis, measurable disease by RECIST v1.1, and good organ/marrow function. It's not for those with certain genetic mutations or unresolved severe side effects from past cancer treatments, heart issues, seizure risks, brain metastases/spinal compression, or uncontrolled high blood pressure.Check my eligibility
What is being tested?
The study tests VVD-130037 to see its safety and how it affects the body and tumor growth in patients with advanced solid tumors. This first-in-human trial will also look at how the drug moves through and out of the body (pharmacokinetics) and what it does to the body (pharmacodynamics).See study design
What are the potential side effects?
As this is a first-in-human study for VVD-130037, potential side effects are being evaluated; however common side effects may include reactions at injection site, fatigue, nausea or other digestive issues based on similar drugs' profiles.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to end of treatment (up to approximately 4 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to end of treatment (up to approximately 4 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence and Severity of Dose-limiting Toxicities (DLTs) During DLT Observation Period
Secondary outcome measures
Apparent Terminal Half-life (T1/2) of VVD-130037
Area Under the Plasma Concentration-time Curve (AUC) of VVD-130037
Maximum Observed Concentration (Cmax) of VVD-130037
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: VVD-130037 Dose EscalationExperimental Treatment1 Intervention
Participants will receive ascending doses of VVD-130037, orally, once daily in 21-day treatment cycles.
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Who is running the clinical trial?
Vividion Therapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
160 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have taken medication for seizures.I have or had cancer spread to my brain or spinal cord.My cancer is confirmed to be advanced and cannot be removed by surgery.I have a history of seizures or a condition that could lead to seizures.My cancer has a mutation that does not respond to VVD-130037 treatment.I have no lasting side effects from cancer treatment worse than Grade 1.My organs and bone marrow are functioning well.I have not had serious heart issues like heart failure, new or worsening chest pain, or a heart attack in the last 6 months.I am fully active or can carry out light work.My high blood pressure is not controlled, even with medication.I have risk factors for irregular heartbeats.My cancer has worsened despite all standard treatments.
Research Study Groups:
This trial has the following groups:- Group 1: VVD-130037 Dose Escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current number of participants for this medical experiment?
"Affirmative. Clinicaltrials.gov indicates that this trial, which was initially posted on July 28th 2023, is currently recruiting participants. Approximately 80 patients are needed to be enrolled from 2 different medical centres."
Answered by AI
Has the administration granted clearance for VVD-130037 Dose Escalation?
"Limited clinical data concerning the safety and efficacy of VVD-130037 Dose Escalation warrants a score of 1 on our team at Power's scale."
Answered by AI
Is this medical research endeavor actively recruiting participants?
"Indeed, the clinicaltrials.gov website demonstrates that this investigation is currently seeking volunteers to participate in the study. This trial was initially posted on July 28th 2023 with a subsequent update published on August 7th 2023; 80 participants must be recruited from 2 sites."
Answered by AI
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