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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must be eligible to use pembrolizumab per USPI (Part 3 and Part 4 US Only)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 cycle 1 day 1 up to 30 days after the last dose, where each cycle is up to 21 days (up to approximately 36 months)
Awards & highlights
Study Summary
This trial is testing the safety and effectiveness of VIP152 as a treatment for solid tumors and aggressive NHL.
Who is the study for?
Adults with advanced solid tumors or aggressive non-Hodgkin's lymphoma that no longer respond to standard treatments and have specific genetic changes (MYC expression/amplification). Participants must be in fairly good health, with their major organs functioning well and able to perform daily activities with minimal assistance.Check my eligibility
What is being tested?
The trial is testing different doses of a new cancer drug called VIP152 alone or combined with Keytruda. The goal is to find the safest dose that can be given without severe side effects (MTD) and decide on a recommended dose for future studies (RP2D).See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site, fatigue, nausea, liver issues, blood count changes which could lead to infections or bleeding problems. Since this is an early-phase study, there may be unknown risks as well.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am eligible to receive pembrolizumab treatment according to US guidelines.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My cancer is not responding to treatment and tests show MYC gene changes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ cycle 1 day 1 up to 30 days after the last dose, where each cycle is up to 21 days (up to approximately 36 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1 day 1 up to 30 days after the last dose, where each cycle is up to 21 days (up to approximately 36 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
AUC from time 0 to the last data point > LLOQ after multiple dosing [AUC(0-tlast)md] of VIP152 (BAY1251152)
AUC from time 0 to the last data point > Lower limit of quantitation (LLOQ) [AUC(0-tlast)] of VIP152 (BAY1251152)
Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of VIP152 (BAY1251152)
+7 moreSecondary outcome measures
Tumor response evaluation based on the response criteria as applicable (RECIST v1.1 criteria for solid tumors and revised Lugano Classification for aggressive NHL)
Trial Design
4Treatment groups
Experimental Treatment
Group I: Dose expansion of VIP152 (BAY 1251152) in combination with Keytruda® (pembrolizumab) / PART 4Experimental Treatment2 Interventions
Investigating combination VIP152 (BAY 1251152) and Keytruda® (pembrolizumab) in a dose expansion cohort in patients with advanced cancer. All subjects must be eligible to use pembrolizumab per USPI.
Group II: Dose expansion of VIP152 (BAY 1251152) / PART 2Experimental Treatment1 Intervention
Investigating VIP152 (BAY 1251152) in a dose expansion cohort in patients with solid tumors and aggressive NHL
Group III: Dose escalation of VIP152 (BAY 1251152) in combination with Keytruda® (pembrolizumab) / PART 3Experimental Treatment2 Interventions
Investigating combination VIP152 (BAY 1251152) and Keytruda® (pembrolizumab) in a dose escalation cohort in patients with advanced cancer. All subjects must be eligible to use pembrolizumab per USPI.
Group IV: Dose escalation of VIP152 (BAY 1251152) / PART 1 (Completed)Experimental Treatment1 Intervention
Investigating VIP152 (BAY 1251152) in a dose escalation cohort in patients with solid tumors and aggressive NHL
Find a Location
Who is running the clinical trial?
Vincerx Pharma, Inc.Lead Sponsor
3 Previous Clinical Trials
66 Total Patients Enrolled
Vincerx Study DirectorStudy DirectorVincerx Pharma, Inc.
3 Previous Clinical Trials
66 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had chemotherapy or immunotherapy in the last week.I had a bone marrow or stem cell transplant more than 4 months ago and finished my immunosuppressive therapy.I am eligible to receive pembrolizumab treatment according to US guidelines.My blood, liver, and kidney tests are within normal ranges.I have not 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 is not responding to treatment and tests show MYC gene changes.I am 18 years old or older.My cancer has spread to my brain or spinal cord.I do not have serious infections worse than Grade 2.
Research Study Groups:
This trial has the following groups:- Group 1: Dose expansion of VIP152 (BAY 1251152) / PART 2
- Group 2: Dose escalation of VIP152 (BAY 1251152) in combination with Keytruda® (pembrolizumab) / PART 3
- Group 3: Dose expansion of VIP152 (BAY 1251152) in combination with Keytruda® (pembrolizumab) / PART 4
- Group 4: Dose escalation of VIP152 (BAY 1251152) / PART 1 (Completed)
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
How many individuals have thus far registered for this experiment?
"To complete this clinical trial, 110 volunteers who meet the prerequisites for inclusion must be enrolled. Highlands Oncology Group in Springdale, Arkansas and Norton Cancer Institute in Louisville Kentucky are two of the many sites offering participation opportunities."
Answered by AI
Is there still an opportunity to join this medical research project?
"Affirmative. Clinicaltrials.gov attests that this trial, which was opened on February 10th 2016, is currently enlisting volunteers. The total number of participants needed totals to 110 across 12 different clinical sites."
Answered by AI
To what extent do the risks of Keytruda outweigh its benefits?
"Due to the limited amount of clinical evidence on Keytruda’s efficacy and safety, it was given a rating of 1 out of 3."
Answered by AI
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