This is a multi-center, first-in-human, open label, dose escalation (Part A) and expansion (Part B) Phase 1 study in subjects with advanced solid tumors and in subjects with solid tumors with selected genetic alterations that are either direct (YES1 amplification) or dependent (Hippo Pathway alterations) targets of NXP900.
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18 years old or older.
Advanced, metastatic, and/or progressive solid tumors for whom there is no authorized or effective therapy available, or for whom such therapies are considered inappropriate by the Investigator.
Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Subjects with known human epidermal growth factor receptor 2 (HER2+) overexpressing malignancies.
Radiotherapy (except for palliative reasons), endocrine therapy, chemotherapy, or investigational agent within 28 days, (42 days for nitrosoureas, mitomycin-C) of first dose of NXP900. Subjects can continue to receive bisphosphonates due to metastatic bone disease or GnRH agonists if they have prostate cancer.
Ongoing toxic manifestations of previous treatments > Grade 2 with the exception of alopecia and neuropathy.
Subjects with treated brain metastases with evidence of progression within 28 days after central nervous system (CNS)-directed treatment, as ascertained by clinical examination and brain imaging (magnetic resonance imaging [MRI] or computed tomography [CT] scan) during the Screening period.
Sequential
NXP900
DrugNXP900 is an orally administered SRC/YES1 kinase inhibitor
Number of patients with treatment related adverse events and/or clinical laboratory abnormalities
Part A: Number of patients who experience Dose Limiting Toxicities (DLT) as defined in the protocol
Part B: Objective response rate (ORR)
Best response of complete response (CR) or partial response (PR) per RECIST 1.1
Part B: Duration of Response (DoR)
Confirmed CR or PR from the first documented response to the date of documented disease progression or death.
Area under the concentration-time curve (AUC) of NXP900
Maximum observed concentration (Cmax) of NXP900
Time to peak concentration (Tmax) of NXP900
Half-life (T1/2) of NXP900
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