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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
No Placebo-Only Group
Summary
This trial tests a new drug, VVD-130037, for safety and effectiveness in patients with advanced solid tumors. It will study how the drug moves through and affects the body, and whether it can help treat these tumors.
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.
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).
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence and Severity of Dose-limiting Toxicities (DLTs) During DLT Observation Period
Secondary study objectives
QT/Corrected QT (QTc) Interval and Other Electrocardiogram (ECG) Parameters
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial 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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but also affects normal cells, leading to side effects.
Targeted therapies, such as tyrosine kinase inhibitors, specifically target molecular pathways crucial for tumor growth and survival, thereby minimizing damage to normal cells. Immunotherapy, including checkpoint inhibitors, enhances the body's immune response against cancer cells.
Investigational drugs like VVD-130037 are designed to improve efficacy and reduce toxicity by focusing on specific molecular targets or pathways involved in tumor progression. Understanding these mechanisms is crucial for solid tumor patients as it helps in selecting the most appropriate and potentially effective treatment with manageable side effects.
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Who is running the clinical trial?
Vividion Therapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
200 Total Patients Enrolled
Media Library
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.