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Phase I Dose Escalation Study for VIP152 in Patients With Advanced Cancer
Trial Status: complete
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).
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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02635672.
Locations matching your search criteria
United States
New Jersey
Hackensack
Hackensack University Medical Center
Status: Active
Name Not Available
Texas
Houston
M D Anderson Cancer Center
Status: Active
Name Not Available
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