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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 24 months
Awards & highlights
Study Summary
This trial tests a new drug to see if it's safe and effective for treating advanced solid tumor cancer.
Who is the study for?
This trial is for adults over 18 with advanced solid tumors that have not responded to standard treatments. Participants must be able to consent, follow study procedures, and have a performance status showing they can carry out daily activities. They need proper bone marrow, liver, and kidney function.Check my eligibility
What is being tested?
The trial is testing VIP236 as a solo treatment given through the vein (IV) to find the highest dose patients can take without severe side effects. It's for those with advanced cancer who've tried all other options or can't use them.See study design
What are the potential side effects?
While specific side effects of VIP236 are not listed here, common ones in such trials include reactions at the infusion site, fatigue, nausea, changes in blood counts affecting immunity and clotting risk, liver or kidney issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of DLT (Dose limit toxicity) of VIP236
Number of participants with adverse events as a measure safety and tolerability
Secondary outcome measures
Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of VIP236
Disease control rate (DCR) per RECIST v1.1, defined as best overall response of complete response (CR), partial response (PR), or stable disease (SD) as determined by Investigator review.
Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of VIP236
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Dose Escalation of VIP236Experimental Treatment1 Intervention
Investigating VIP236 in a dose escalation cohort in subjects with advanced solid tumor cancer
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Who is running the clinical trial?
Vincerx Pharma, Inc.Lead Sponsor
3 Previous Clinical Trials
152 Total Patients Enrolled
Vincerx Study DirectorStudy DirectorVincerx Pharma, Inc.
3 Previous Clinical Trials
152 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have serious heart problems like recent heart attacks or severe chest pain.My blood, liver, and kidney tests are within normal ranges.I am 18 or older, can give consent, and will follow the study rules.I have a history of COPD or other lung problems.My cancer has spread to my brain, meninges, or spine.I haven't had major surgery or significant injury in the last 4 weeks.I can take care of myself and am up and about more than half of my waking hours.My cancer has returned or didn't respond to treatment and I've tried all standard treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation of VIP236
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.
To what extent could Dose Escalation of VIP236 be hazardous for patients?
"We've rated the safety of Dose Escalation of VIP236 on a scale from 1 to 3 and awarded it a score of one due to its Phase 1 status; this indicates that there is limited data regarding both efficacy and safety."
Answered by AI
How many participants have been approved for this trial thus far?
"Affirmative. Clinicaltrials.gov's records confirm that this medical research project, initially posted on January 24th 2023, is currently recruiting patients. There are a total of 24 participants needed for the study to be conducted at one specific site."
Answered by AI
Are there any remaining slots available in this clinical research program?
"Affirmative. According to clinicaltrials.gov, enrollment for this medical trial is open as of now. Initially posted on January 24th 2023 and most recently amended on February 3rd 2021, the study requires 24 participants from a single healthcare facility."
Answered by AI
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