Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact
Active, not recruiting Phase 1

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

NCT05873686 · tracked via the Priya Life Science UK tracker
Phase
Phase 1
Started
2023-10-26
Last updated
2026-09-30

Condition(s) studied

Advanced Solid TumorNSCLC (Non-small Cell Lung Cancer)Renal CancerMesotheliomaNon-Small Cell Squamous Lung CancerNon-small Cell Lung Adenocarcinoma

Investigational drug(s) / intervention(s)

NXP900 →

NXP900: NXP900 is an orally administered SRC/YES1 kinase inhibitor

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Part A Inclusion 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. Exclusion Criteria: 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. Part B: Inclusion Criteria: 1. Provide written informed consent. 2. 18 years old or older. 3. Advanced, metastatic, and/or progressive solid tumors with pathogenic molecular alterations: 1. Non-small cell lung cancer (adenocarcinoma); YES1, TYMS amplification or FAT1 pathogenic mutation 2. Non-small cell lung cancer (squamous cell carcinoma); YES1, TYMS amplification or FAT1 pathogenic mutation 3. Renal cancer; NF2 pathogenic mutation 4. Mesothelioma; NF2 pathogenic mutation 5. Other solid tumors with a NF2, FAT1 or LATS1 pathogenic gene mutation or TYMS, YAP1, YES1, or TAZ1 gene amplification, or cholangiocarcinoma with IDH1 or IDH2 mutations. 4. Must have received 1-3 prior therapies appropriate for their tumor type and stage of disease 5. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (or mRECIST 1.1 for subjects with pleural mesothelioma). 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Exclusion Criteria: 1. Subjects with the following combination of cancer type and pathogenic molecular alterations are excluded: 1. Subjects with colorectal cancer, glioma, melanoma, or anaplastic thyroid conditions with BRAF mutations. 2. Subjects with NSCLC with BRAF or EGFR mutations or HER2 overexpression. 3. Subjects with breast cancer, gastric cancer, esophageal junction adenocarcinoma or biliary cancer with HER2 alterations, 2. Subjects with anal, penile, cervical or head and neck cancers with a prior history of human papilloma virus (HPV) infection. 3. Radiotherapy (except for palliative reasons), endocrine therapy, chemotherapy, or investigational agent within 28 days (42 days for nitrosoureas, mitomycin-C) prior to first dose of NXP900. Subjects can continue to receive bisphosphonates due to metastatic bone disease or GnRH agonists if they have prostate cancer. 4. Ongoing toxic manifestations of previous treatments \> Grade 2 with the exception of alopecia and neuropathy. 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.

Primary outcome measure(s)

  • Number of patients with treatment related adverse events and/or clinical laboratory abnormalities — Up to 30 days post treatment
  • Part A: Number of patients who experience Dose Limiting Toxicities (DLT) as defined in the protocol — Day 28
  • Part B: Objective response rate (ORR) — Up to 24 months
    Best response of complete response (CR) or partial response (PR) per RECIST 1.1 (or mRECIST 1.1 for subjects with pleural mesothelioma).
  • Part B: Duration of Response (DoR) — Up to 24 months
    Confirmed CR or PR from the first documented response to the date of documented disease progression or death.
  • Part B: Disease Control Rate (DCR) — Up to 24 months
    The proportion of patients with stable disease (SD), partial response (PR), or complete response (CR).

Trial sites (15)

FacilityCityRegionStatus
Mayo Clinic Phoenix Arizona
UC San Diego Moores Cancer Center La Jolla California
Sarah Cannon Research Institute at HealthONE Denver Colorado
Mayo Clinic Jacksonville Florida
University of Chicago Chicago Illinois
Mayo Clinic Rochester Rochester Minnesota
Memorial Sloan Kettering Cancer Center New York New York
Cleveland Clinic Cleveland Ohio
Oregon Health and Science University Portland Oregon
The University of Texas MD Anderson Cancer Center Houston Texas
NEXT Oncology Houston Houston Texas
NEXT Oncology Dallas Irving Texas
NEXT Oncology Virginia Fairfax Virginia
Western General Hospital - NHS Lothian Edinburgh United Kingdom
The Royal Marsden NHS Foundation and Trust London United Kingdom
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05873686 on ClinicalTrials.gov ↗ ← All trials in the UK