Breast Cancer Clinical Trial
Phase I Dose Escalation Study for VIP152 in Patients With Advanced Cancer
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).
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).
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
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.
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There are 16 Locations for this study
Springdale Arkansas, 72762, United States
Louisville Kentucky, 40202, United States
Silver Spring Maryland, 20904, United States
Hackensack New Jersey, 07601, United States
New York New York, 10065, United States
Cincinnati Ohio, 45219, United States
Eugene Oregon, 97401, United States
Portland Oregon, 97239, United States
Sioux Falls South Dakota, 57105, United States
Nashville Tennessee, 37203, United States
Austin Texas, 78758, United States
Houston Texas, 77030, United States
San Antonio Texas, 78229, United States
Viña Del Mar Valparaíso, 25403, Chile
Viña del Mar , 25205, Chile
Madrid , 28040, Spain
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