Breast Cancer Clinical Trial

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

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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Full 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).

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Eligibility Criteria

Part 2 (Global), Part 3 (US Only), and Part 4 (US Only)

Inclusion Criteria:

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.

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

110

Study ID:

NCT02635672

Recruitment Status:

Active, not recruiting

Sponsor:

Vincerx Pharma, Inc.

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There are 16 Locations for this study

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Highlands Oncology Group
Springdale Arkansas, 72762, United States
Norton Cancer Institute
Louisville Kentucky, 40202, United States
Maryland Oncology Hematology
Silver Spring Maryland, 20904, United States
John Theurer Cancer Center
Hackensack New Jersey, 07601, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
University of Cincinnati Medical Center
Cincinnati Ohio, 45219, United States
Willamette Valley Cancer Institute
Eugene Oregon, 97401, United States
Oregon Health and Science University
Portland Oregon, 97239, United States
Avera Health
Sioux Falls South Dakota, 57105, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
NEXT Oncology
Austin Texas, 78758, United States
University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
NEXT Oncology
San Antonio Texas, 78229, United States
Centro de Investigaciones Clínicas Viña del Mar
Viña Del Mar Valparaíso, 25403, Chile
Oncocentro
Viña del Mar , 25205, Chile
START Madrid- Fundación Jiménez Diaz
Madrid , 28040, Spain

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

110

Study ID:

NCT02635672

Recruitment Status:

Active, not recruiting

Sponsor:


Vincerx Pharma, Inc.

How clear is this clinincal trial information?

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