A Phase 1 Clinical Study of NXP900 in Subjects with Advanced Cancers
- Registration Number
- NCT05873686
- Lead Sponsor
- Nuvectis Pharma, Inc.
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- 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.
Exclusion Criteria
- Subjects with known human epidermal growth factor receptor 2 (HER2+) overexpressing malignancies.
- 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.
- Ongoing toxic manifestations of previous treatments > Grade 2 with the exception of alopecia and neuropathy.
- 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.
- 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 .
- 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).
- Major surgery from which the subject has not yet recovered.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose Escalation NXP900 Escalating doses of NXP900 are planned with a starting dose level of 20 mg once per day.
- Primary Outcome Measures
Name Time Method Number of patients with treatment related adverse events and/or clinical laboratory abnormalities Day 28 Number of patients who experience Dose Limiting Toxicities (DLT) as defined in the protocol Day 28
- Secondary Outcome Measures
Name Time Method Maximum observed concentration (Cmax) of NXP900 First dose through Day 29 Apparent volume of distribution at steady state (Vss/F) of NXP900 First dose through Day 29 Area under the concentration-time curve (AUC) of NXP900 First dose through Day 29 Time to peak concentration (Tmax) of NXP900 First dose through Day 29 Apparent plasma clearance at steady state (Clss/F) of NXP900 First dose through Day 29 Half-life (T1/2) of NXP900 First dose through Day 29
Trial Locations
- Locations (6)
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
Sarah Cannon Research Institute at HealthONE
🇺🇸Denver, Colorado, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Western General Hospital - NHS Lothian
🇬🇧Edinburgh, United Kingdom
The Royal Marsden NHS Foundation and Trust
🇬🇧London, United Kingdom
Mayo Clinic🇺🇸Jacksonville, Florida, United States