The SRC family kinase inhibitor NXP900 demonstrates potent antitumor activity in squamous cell carcinomas.
Sweta Dash, Sabrina Hanson, Ben King...
https://pubmed.ncbi.nlm.nih.gov/39089584Actively Recruiting
Phase 1
Age: 18Years +
All Genders
ID05873686
A Phase 1 Clinical Study of NXP900 in Subjects With Advanced Cancers
Led by Nuvectis Pharma, Inc. · Updated on 2026-03-03
140
Participants Needed
12
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the drug NXP900 in people with advanced solid tumors, including specific genetic alterations affecting certain pathways related to cancer growth. This first-in-human Phase 1 study aims to understand how patients tolerate NXP900 and how their tumors respond to it. The study focuses on tumors with direct or dependent targets of the drug, such as YES1 amplification and Hippo Pathway alterations, to explore new treatment options for patients with limited therapies. The study has two parts: Part A involves escalating doses of NXP900 starting at 20 mg once daily to find a safe dose, while Part B expands the study to more participants receiving the selected dose. NXP900 is an oral drug taken once per day. Participants continue on their assigned doses while researchers monitor safety and effectiveness. The study is open label and non-randomized, meaning all participants know they are receiving NXP900 without a comparison placebo or alternative treatment. Participants will be involved in regular assessments including imaging scans to measure tumor size, clinical exams, laboratory tests, and monitoring for side effects. Researchers will track treatment-related adverse events, dose-limiting toxicities, and tumor response rates over periods up to 24 months. The study also measures how the drug is processed in the body through blood tests. Participation length varies depending on treatment response and safety, with follow-up extending up to two years to gather comprehensive data.
CONDITIONS
Brief Title
A Phase 1 Clinical Study of NXP900 in Subjects With Advanced Cancers
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Provide written informed consent.
- Be 18 years old or older.
- Have advanced, metastatic, and/or progressive solid tumors with no authorized or effective therapy available or for whom such therapies are inappropriate.
- Have measurable disease according to RECIST Version 1.1.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- For Part B, have specific pathogenic molecular alterations and have received 1-3 prior appropriate therapies.
You will not qualify if you...
- Known HER2+ overexpressing malignancies.
- Recent radiotherapy (except palliative), endocrine therapy, chemotherapy, or investigational agent within 28 days (42 days for certain drugs) before first dose.
- Ongoing toxic effects from previous treatments above Grade 2 except alopecia and neuropathy.
- Brain metastases progressing within 28 days after CNS treatment.
- Female participants who are pregnant, lactating, or can become pregnant without negative pregnancy test and contraceptive agreement.
- Male participants with partners of childbearing potential not agreeing to contraceptive measures.
- Major surgery not yet recovered from.
- Specific cancer types with certain gene alterations excluded in Part B.
- History of HPV infection in certain cancers excluded in Part B.
- Same recent treatment restrictions as Part A for Part B.
- Same ongoing toxicity and reproductive exclusions as Part A for Part B.
- Same major surgery recovery exclusion as Part A for Part B.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 24 months
Participants receive escalating doses of the study drug NXP900 or the selected dose to treat advanced cancers.
Regular visits during dosing period
Follow-up
Duration - Up to 30 days post treatment
Participants are monitored for treatment-related adverse events and clinical outcomes after treatment ends.
Approximately 1 follow-up visit
Trial Site Locations
Total: 12 locations
1
Mayo Clinic
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States, 80218
Actively Recruiting
3
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
4
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
5
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
6
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
7
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
8
NEXT Oncology Houston
Houston, Texas, United States, 77054
Actively Recruiting
9
NEXT Oncology Dallas
Irving, Texas, United States, 75039
Actively Recruiting
10
NEXT Oncology Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
11
Western General Hospital - NHS Lothian
Edinburgh, United Kingdom, EH4 2XU
Completed
12
The Royal Marsden NHS Foundation and Trust
London, United Kingdom, SW3 6JJ
Completed
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Research Team
E
Erin Belshaw
S
Shay Shemesh
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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