A Phase 1 Clinical Study of NXP900 in Subjects with Advanced Cancers

Eligibility Criteria

• 1. Provide written informed consent.
• 2. 18 years old or older.
• 3. 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.
• 4. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
• 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• 1. Subjects with known human epidermal growth factor receptor 2 (HER2+) overexpressing malignancies.
• 2. 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.
• 3. Ongoing toxic manifestations of previous treatments \> Grade 2 with the exception of alopecia and neuropathy.
• 4. 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.
• 5. Female subjects who can become pregnant (or are already pregnant or lactating), unless they have a negative serum pregnancy test before enrollment and agree to use at least one highly effective form of contraception .
• 6. Male subjects with partners of childbearing potential, unless they agree to take measures not to father children by using a barrier method of contraception (condom plus spermicide).
• 7. Major surgery from which the subject has not yet recovered.