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Virus Therapy
Intratumoral VAX014 for Cancer
Phase 1
Recruiting
Research Sponsored by Vaxiion Therapeutics
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 28 days
Awards & highlights
Study Summary
This trial will test a drug that targets & destroys tumor cells after being injected into advanced solid tumors. It will evaluate safety, tolerability & activity.
Who is the study for?
This trial is for adults with advanced solid tumors that have stopped responding to standard treatments. Participants must have a tumor between 1 and 10 cm in size that can be injected directly or with ultrasound guidance, and they should not be candidates for surgery or systemic treatment as per the investigator's assessment.Check my eligibility
What is being tested?
The study is testing VAX014, an experimental cancer therapy given by injection directly into the tumor. The goal is to see if it's safe, tolerable, and effective at killing cancer cells in patients with advanced solid tumors.See study design
What are the potential side effects?
Potential side effects of VAX014 are not detailed here but may include reactions at the injection site, general immune responses due to oncolytic activity such as fever or fatigue, and other effects typical of agents that target tumor cells.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 20 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 20 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Treatment-Emergency Adverse Events (Safety and Tolerability)
Maximum tolerated dose (MTD) of VAX014
Recommended Phase 2 Dose (RP2D) of intratumoral VAX014
Secondary outcome measures
Anti-Drug Antibodies (Immunogenicity)[systemic ADA]
Characterize systemic exposure by evaluating pharmacokinetics of intratumoral VAX014 [systemic PK]
Overall Response Rate
Other outcome measures
Anti-Tumor T Cells
Cytokine levels
RIG-I expression
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: VAX014Experimental Treatment1 Intervention
Dose escalation of VAX014 [recombinant bacterial minicells (rBMCs)] intratumoral injections alone for subjects with solid tumors relapsed and/or refractory to standard treatment and appropriate for injection of a nodal, subcutaneous, or cutaneous tumor via palpation or with the assistance of ultrasound. In dose expansion, injection may be in metastatic tumors with or without the need for interventional radiology.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VAX014
2019
Completed Phase 1
~10
Find a Location
Who is running the clinical trial?
Vaxiion TherapeuticsLead Sponsor
1 Previous Clinical Trials
6 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on a daily dose of more than 10 mg of prednisone or its equivalent.I have an active Hepatitis B or C infection.I am 18 years old or older.I am not pregnant or breastfeeding.My condition worsened after standard treatment or I couldn't tolerate it.I can take care of myself and am up and about more than half of my waking hours.My brain metastases are treated and stable without steroids for 2 weeks.I am currently on antibiotics for an active infection.It's been less than 28 days since my last cancer treatment.I haven't taken warfarin, heparin, or NSAIDs like aspirin in doses over 81 mg daily in the last 14 days.My tumor is too close to vital body parts, making treatment risky due to swelling.I don't expect to need treatment for another cancer within 2 years, except for minor ones like skin cancer.My cancer is advanced, cannot be surgically removed, and systemic treatment is not suitable.There are no standard treatments that would help my condition.I have a tumor that can be felt or seen with ultrasound, suitable for injection.I have a tumor that can be injected, measuring 1 to 10 cm.My cancer has returned or didn’t respond to standard treatments.I need medication to suppress my immune system.My liver and kidney functions are within normal limits.
Research Study Groups:
This trial has the following groups:- Group 1: VAX014
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 the Food and Drug Administration given its stamp of approval to VAX014?
"VAX014 has not yet received extensive safety and efficacy testing, so our team gave it a score of 1."
Answered by AI
Is this trial accepting new participants?
"The clinical trial detailed on clinicaltrials.gov is not actively recruiting participants at the moment - it was initially published in July of 2023 and last updated June 2nd, 2023. However, there are 512 other medical trials that could still benefit from new volunteers today."
Answered by AI
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