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Trial Title:
A Phase 1 Clinical Study of NXP900 in Subjects With Advanced Cancers
NCT ID:
NCT05873686
Condition:
Advanced Solid Tumor
Conditions: Keywords:
Solid Tumor
Carcinoma
Neoplasms
Adenocarcinoma
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Intervention model description:
Sequential assignment, dose escalation
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
NXP900
Description:
NXP900 is an orally administered SRC/YES1 kinase inhibitor
Arm group label:
Dose Escalation
Summary:
The purpose of this dose escalation study is to evaluate the safety profile of escalating
doses and dose schedules of NXP900.
Detailed description:
This is a dose escalation study of NXP900 administered to patients with advanced cancers.
The study will propose dose and dose schedules for future studies.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic
Address:
City:
Phoenix
Zip:
85054
Country:
United States
Status:
Recruiting
Contact:
Phone:
855-776-0015
Facility:
Name:
Sarah Cannon Research Institute at HealthONE
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Recruiting
Contact:
Phone:
720-754-2610
Facility:
Name:
Mayo Clinic
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Status:
Recruiting
Contact:
Phone:
855-776-0015
Facility:
Name:
Oregon Health and Science University
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Recruiting
Contact:
Phone:
503-494-6865
Facility:
Name:
The University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jordi Rodon Ahnert, MD, PhD
Phone:
713-792-5603
Facility:
Name:
Ward 1 - Edinburgh Cancer Centre, Western General Hospital
Address:
City:
Edinburgh
Zip:
EH4 2XU
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Christen Lauder
Phone:
0131 537 1265
Email:
christen.lauder@nhs.scot
Facility:
Name:
The Royal Marsden NHS Foundation and Trust
Address:
City:
London
Zip:
SW3 6JJ
Country:
United Kingdom
Status:
Recruiting
Start date:
October 26, 2023
Completion date:
January 2025
Lead sponsor:
Agency:
Nuvectis Pharma, Inc.
Agency class:
Industry
Source:
Nuvectis Pharma, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05873686
