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Virus Therapy
VT1021 for Advanced Cancer
Phase 1
Waitlist Available
Research Sponsored by Vigeo Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Dose Expansion Phase - Triple Negative Breast Cancer: Patients with confirmed diagnosis of metastatic TNBC must have received ≤ 3 prior lines of therapy for metastatic disease
Dose Expansion Phase - Glioblastoma: Patients with confirmed relapsed or refractory glioblastoma must have received ≤2 prior lines of systemic therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial is to test the safety of VT1021 in patients with advanced cancer that has no potential for cure.
Who is the study for?
This trial is for adults with advanced solid tumors where standard treatments won't cure them. Specific groups include those with certain ovarian, pancreatic, triple negative breast cancer (TNBC), glioblastoma, or CD36-high cancers who've had a limited number of prior therapies. Participants must be in fair health based on ECOG scale and agree to contraception use.Check my eligibility
What is being tested?
The study tests VT1021's effects on various advanced solid tumors. It's an open-label Phase I trial meaning everyone gets the drug and there’s no placebo group. The focus is on how safe it is and what dose might work best across different types of cancer.See study design
What are the potential side effects?
As this is an early-phase trial for VT1021, specific side effects aren’t listed but may include typical reactions to cancer drugs such as nausea, fatigue, risk of infection, organ inflammation among others depending on individual patient response.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have triple negative breast cancer and received 3 or fewer treatments for it after it spread.
Select...
I have glioblastoma and have had 2 or fewer treatments for it.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I have pancreatic cancer and have had 2 or fewer previous treatments.
Select...
I haven't had chemotherapy or radiation for at least 21 days, or 12 weeks if I have glioblastoma.
Select...
My cancer does not respond to or I cannot tolerate current treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Identify recommended phase 2 dose by measuring incidence of dose limiting toxicities at increasing dose levels. Determine the safety and tolerability of VT1021 in ovarian, pancreatic, triple negative breast cancer, glioblastoma and CD36 high cohort.
Secondary outcome measures
To analyze the serum/plasma levels collected from patients for concentrations of VT1021 using non-compartmental analysis to estimate the pharmacokinetic parameter of AUC0-t
To analyze the serum/plasma levels collected from patients for concentrations of VT1021 using non-compartmental analysis to estimate the pharmacokinetic parameter of AUC0-∞
To analyze the serum/plasma levels collected from patients for concentrations of VT1021 using non-compartmental analysis to estimate the pharmacokinetic parameter of Cmax
+6 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: VT1021Experimental Treatment1 Intervention
Escalating doses of VT1021 to determine RP2D
Find a Location
Who is running the clinical trial?
Vigeo Therapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
1,030 Total Patients Enrolled
Judy Chaio, MDStudy DirectorMedical Director
Lou Vaickus, MDStudy DirectorMedical Director
1 Previous Clinical Trials
11 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have triple negative breast cancer and received 3 or fewer treatments for it after it spread.I haven't been diagnosed with a new cancer, except for certain non-aggressive types, in the past 2 years.I have glioblastoma and have had 2 or fewer treatments for it.I can take care of myself and am up and about more than half of my waking hours.I need radiation for specific cancer spots as per my study entry.I have brain metastases but have been treated and am stable.I have ovarian, fallopian tube, or peritoneal cancer, treated ≤3 times in a platinum-resistant setting. BRCA mutation present only if failed PARP inhibitor.I have pancreatic cancer and have had 2 or fewer previous treatments.I haven't had major surgery or significant injury in the last 14 days and don't expect any during the study.My cancer has high CD36 and I've had 3 or fewer treatments for it.I haven't had chemotherapy or radiation for at least 21 days, or 12 weeks if I have glioblastoma.My organs are functioning well.My cancer does not respond to or I cannot tolerate current treatments.I am not currently receiving any other cancer treatments.
Research Study Groups:
This trial has the following groups:- Group 1: VT1021
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.
Has VT1021 been sanctioned by the FDA?
"With few clinical data points to draw from, our team at Power concluded that the safety of VT1021 is a 1 on a 3-point scale. This assessment was made because it is currently in Phase 1 trials and thus has yet to be proven efficacious or safe."
Answered by AI
Are there numerous sites conducting this medical research within the borders of our state?
"This clinical trial is presently enrolling subjects in 12 different locations, including Chicago, Cleveland and Houston. To reduce any extra travel needs for participants it might be beneficial to select the most proximate site of these dozen options."
Answered by AI
Are there still openings in this research endeavor for participants?
"The information present on clinicaltrials.gov suggests this particular trial has ceased recruitment. It was first advertised on November 28th 2017 and the most recent update is from October 21st 2022; though, there are over two-thousand five hundred eighty four other studies actively searching for participants presently."
Answered by AI
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