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Phase I Dose Escalation Study for VIP152 in Patients With Advanced Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

An Open-label, Multicenter Phase I Dose Escalation Study to Characterize Safety, Tolerability, Preliminary Anti-tumor Activity, Pharmacokinetics and Maximum Tolerated Dose of VIP152 (BAY 1251152) as Monotherapy or Combination Therapy in Subjects With Advanced Cancer.

NCT02635672•Vincerx Pharma, Inc.

View on ClinicalTrials.gov

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).

Detailed Description

Part 2 VIP152 Monotherapy (Global). Part 3 dose escalation with VIP152 in combination with pembrolizumab (US only). Part 4 dose expansion with VIP152 in combination with pembrolizumab (US only).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion 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

Exclusion 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.

Locations (16)

Highlands Oncology Group

Springdale, Arkansas, United States

Norton Cancer Institute

Louisville, Kentucky, United States

Maryland Oncology Hematology

Silver Spring, Maryland, United States

John Theurer Cancer Center

Hackensack, New Jersey, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Willamette Valley Cancer Institute

Eugene, Oregon, United States

Oregon Health and Science University

Portland, Oregon, United States

Avera Health

Sioux Falls, South Dakota, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Key Dates

Start Date

February 10, 2016

Primary Completion Date

November 11, 2024

Completion Date

November 11, 2024

Last Updated

November 15, 2024

Enrollment

110

ESTIMATED participants

Conditions

Neoplasms

Interventions

VIP152 (BAY 1251152)

DRUG

VIP152 (BAY 1251152) 30 mg

DRUG

Keytruda

DRUG

VIP152 (BAY 1251152) 15 mg

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 15, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

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