To determine and evaluate a safe and tolerated dose of HDM201 in adult patients with selected advanced tumors characterized by wild-type TP53.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
208
Dana Farber Cancer Institute SC-6
Boston, Massachusetts, United States
Memorial Sloan Kettering Onc. Dep
New York, New York, United States
Novartis Investigative Site
Lyon, France
Incidence of dose limiting toxicities (DLTs)
DLTs in the first cycle of treatment.
Time frame: up to 28 days
Number of patients with adverse events (AEs)
Number of patients with AEs as a measure of Safety and tolerability of HDM201 single agent.
Time frame: For the duration of treatment, an average of 16 weeks
Pharmacokinetics (PK) parameters of HDM201
Time frame: Up to 42 days
Changes from baseline of Pharmacodynamics markers
Time frame: Baseline, up to 28 days
Tumor response
end of treatment = 1 year
Time frame: Every 8 weeks (for solid tumors), every cycle (for hematological tumors) until end of treatment
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Novartis Investigative Site
Paris, France
Novartis Investigative Site
Essen, Germany
Novartis Investigative Site
Frankfurt, Germany
Novartis Investigative Site
Würzburg, Germany
Novartis Investigative Site
Kobe, Hyōgo, Japan
Novartis Investigative Site
Chuo Ku, Tokyo, Japan
Novartis Investigative Site
Amsterdam, Netherlands
...and 5 more locations