Your session is about to expire
← Back to Search
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 at study visits on day 1, day 10, day 29, day 57, day 85 or early termination visit
Awards & highlights
Study Summary
This trial studies if a new drug to treat pain is safe and tolerable when given through a vein.
Who is the study for?
This trial is for adults with advanced solid tumors that have worsened after treatment, including immune therapies and targeted drugs. Participants must have measurable disease, be relatively active (ECOG 0 or 1), and expected to live at least 3 more months. It's not for those who've had recent major surgery, significant heart issues, active infections needing strong meds, HIV/hepatitis B/C, blood cancers, need high-dose steroids or are pregnant/breastfeeding.Check my eligibility
What is being tested?
The study tests the safety of a new drug called ICVB-1042 given through the veins to people with certain types of tumors. The main goal is to see how well patients tolerate this drug and what doses are safe.See study design
What are the potential side effects?
While specific side effects aren't listed here since it's a safety trial for ICVB-1042, common ones may include reactions at the injection site, fatigue, nausea or allergic responses. More details would emerge as the trial progresses.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at study visits on day 1, day 10, day 29, day 57, day 85 or early termination visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at study visits on day 1, day 10, day 29, day 57, day 85 or early termination visit
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety of intravenous ICVB-1042
Secondary outcome measures
Concentration profile of ICVB-1042 in plasma
Determine immunogenicity of ICVB-1042
Other outcome measures
Concentration of ICVB-1042 in tumor biopsy
Evaluate shedding of ICVB-1042
Evaluate viral replication
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: ICVB-1042Experimental Treatment1 Intervention
Part A: Dose escalation Part B: Dose expansion
Find a Location
Who is running the clinical trial?
IconOVir BioLead Sponsor
Julie Maltzman, MDStudy DirectorIconOVir Bio
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had any vaccines or antiviral drugs in the last 28 days.I haven't taken any biologic treatments for my condition in the last 28 days or 5 half-lives, whichever is longer.I am taking more than 10 mg/day of prednisone or a similar medication.I am not pregnant or breastfeeding.My cancer has returned or didn't respond to treatment, including immunotherapy and targeted therapy.I am fully active or can carry out light work.I am currently on medication for a serious infection.I have a history of serious heart problems.My cancer has spread to the lining of my brain and spinal cord.I have a blood cancer, whether or not it's currently being treated.My cancer has spread to the lung's lymph channels.I do not have active HIV, hepatitis B or C, or any other active viral diseases.My brain metastases are treated and stable for 2 weeks without steroids.I have not had major surgery in the last 28 days.I received targeted radiation for symptom relief within the last 14 days.My oxygen levels are below 90% or I need extra oxygen.
Research Study Groups:
This trial has the following groups:- Group 1: ICVB-1042
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.
Are researchers currently recruiting participants for this study?
"Confirmatory evidence from clinicaltrials.gov reveals that this experiment is currently seeking volunteers; it was initially posted on May 24th, 2023 with the most recent amendment taking place June 6th, 2023."
Answered by AI
How many distinct locations are conducting this research trial?
"This trial is currently inviting patients to participate from 10 different sites, including the Karmanos Cancer Institute in Detroit, NYU Langone Health, Perlmutter Cancer Center in New york and University of North carolina Lineberger Comprehensive Cancer Centre in Chapel Hill. There are also 6 other locations that may be suitable for potential participants."
Answered by AI
Has ICVB-1042 been given the greenlight by the FDA?
"While currently only in Phase 1, ICVB-1042 has generated sufficient data to be rated a 1 on the safety scale. This indicates limited evidence pointing towards its efficacy and safety."
Answered by AI
What is the scope of this investigation in terms of human participants?
"This clinical trial requires 44 patients that meet the prerequisites of participation. Two locations where these participants can be found are Karmanos Cancer Institute in Detroit, Michigan and NYU Langone Health's Perlmutter Cancer Center in New york City."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger