A Phase 1 Clinical Study of NXP900 in Subjects With Advanced Cancers
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.
• Provide written informed consent.
• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Provide written informed consent.
• 18 years old or older.
• Advanced, metastatic, and/or progressive solid tumors with pathogenic molecular alterations:
‣ Non-small cell lung cancer (adenocarcinoma); YES1, TYMS amplification or FAT1 pathogenic mutation
⁃ Non-small cell lung cancer (squamous cell carcinoma); YES1, TYMS amplification or FAT1 pathogenic mutation
⁃ Renal cancer; NF2 pathogenic mutation
⁃ Mesothelioma; NF2 pathogenic mutation
⁃ Other solid tumors with a NF2, FAT1 or LATS1 pathogenic gene mutation or TYMS, YAP1, YES1, TAZ1 gene amplification
• Must have received 1-3 prior therapies appropriate for their tumor type and stage of disease
• Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.