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VIP152 for Cancer

Phase 1

Waitlist Available

Research Sponsored by Vincerx Pharma, Inc.

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

Must not have

Anticancer chemotherapy or immunotherapy during the study or within 1 weeks prior to the first dose of study drug

Allogeneic bone marrow transplant or stem cell rescue within 4 months before first dose of study drug; patients must have completed immunosuppressive therapy before enrollment.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

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.

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).

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 below

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I am eligible to receive pembrolizumab treatment according to US guidelines.

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I can take care of myself and am up and about more than half of my waking hours.

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My cancer is not responding to treatment and tests show MYC gene changes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had chemotherapy or immunotherapy in the last week.

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I had a bone marrow or stem cell transplant more than 4 months ago and finished my immunosuppressive therapy.

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My cancer has spread to my brain or spinal cord.

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I do not have serious infections worse than Grade 2.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

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.

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

VIP152 (BAY 1251152)

2016

Completed Phase 1

~110

VIP152 (BAY 1251152) 30 mg

2016