Phase I Dose Escalation Study for VIP152 in Patients With Advanced Cancer

Study summary

Determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of VIP152 (BAY 1251152) as monotherapy or in combination in patients with solid tumors and aggressive non-hodgkin's lymphoma (NHL).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedVIP152 (BAY 1251152) and VIP152 (BAY 1251152) 30 mg

Plus 2 other study approaches.

Who it may be forNeoplasms

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 15, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?16 U.S. locations

Locations may change over time.

Who runs it?Vincerx Pharma, Inc.

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Vincerx Pharma, Inc.
Interventions being studied: Drug: VIP152 (BAY 1251152); Drug: VIP152 (BAY 1251152) 30 mg; Drug: Keytruda; Drug: VIP152 (BAY 1251152) 15 mg

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Part 2 (Global), Part 3 (US Only), and Part 4 (US Only)
Male or female patients aged \>/=18 years
Patients with a histologically or cytologically confirmed solid tumor or aggressive NHL who are refractory to or have exhausted all available therapies with MYC expression or known C-MYC amplification/alterations
Adequate bone marrow, liver, and renal functions
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 In the addition to the above Part 3 (US Only) and Part 4 (US Only)
Must be eligible to use pembrolizumab per USPI

Reasons someone may not be able to joinExclusion criteria

Active clinically serious infections of events \> Grade 2
Subjects who have new or progressive brain or meningeal or spinal metastases.
Anticancer chemotherapy or immunotherapy during the study or within 1 weeks prior to the first dose of study drug
Major surgery or significant trauma within 4 weeks before 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Highlands Oncology GroupSpringdale, Arkansas
Norton Cancer InstituteLouisville, Kentucky
Maryland Oncology HematologySilver Spring, Maryland
John Theurer Cancer CenterHackensack, New Jersey
Memorial Sloan Kettering Cancer CenterNew York, New York
University of Cincinnati Medical CenterCincinnati, Ohio
Willamette Valley Cancer InstituteEugene, Oregon
Oregon Health and Science UniversityPortland, Oregon
Avera HealthSioux Falls, South Dakota
Sarah Cannon Research InstituteNashville, Tennessee
NEXT OncologyAustin, Texas
University of Texas MD Anderson Cancer CenterHouston, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 15, 2024. Always confirm current availability with the study team.

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