Actively Recruiting
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
192 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase 1 Clinical Study of NXP900 in Subjects With Advanced Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent.
- Be 18 years old or older.
- Have advanced, metastatic, or progressive solid tumors with no authorized or effective therapy available, or such therapy is inappropriate (Part A).
- Have measurable disease according to RECIST Version 1.1.
- Have an ECOG performance status of 0-1.
- For Part B, have advanced solid tumors with specific pathogenic molecular alterations (YES1, TYMS amplification, FAT1 mutation in NSCLC; NF2 mutation in renal cancer or mesothelioma; or NF2, FAT1, LATS1 mutation or TYMS, YAP1, YES1, TAZ1 amplification in other solid tumors).
- Have received 1-3 prior therapies appropriate for their tumor type and stage (Part B).
You will not qualify if you...
- Have known HER2+ overexpressing malignancies (Part A).
- Have received radiotherapy (except palliative), endocrine therapy, chemotherapy, or investigational agents within 28 days (42 days for nitrosoureas, mitomycin-C) prior to first dose.
- Have ongoing toxic effects from previous treatments above Grade 2, except alopecia and neuropathy.
- Have treated brain metastases with progression within 28 days after CNS-directed therapy.
- Female subjects who are pregnant, lactating, or can become pregnant without a negative pregnancy test and use of effective contraception.
- Male subjects with partners of childbearing potential who do not agree to use barrier contraception.
- Have had major surgery from which they have not yet recovered.
- Have certain cancer types with specific mutations excluded in Part B (e.g., colorectal cancer, glioma, melanoma, anaplastic thyroid with BRAF mutations; NSCLC with BRAF, EGFR, or HER2 alterations; breast, gastric, esophageal junction adenocarcinoma, or biliary cancer with HER2 alterations; anal, penile, cervical, or head and neck cancers with prior HPV infection).
AI-Screening
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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
Research Team
E
Erin Belshaw
CONTACT
S
Shay Shemesh
CONTACT
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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