Clinical trial NCT05873686: A Phase 1 Clinical Study of NXP900 in Subjects with Advanced Cancers
Official title: A Phase 1 Clinical Study of NXP900 in Subjects with Advanced Cancers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumor
Keywords: Solid Tumor
Carcinoma
Neoplasms
Adenocarcinoma
Lead sponsor: Nuvectis Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Sequential assignment, dose escalation
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of patients with treatment related adverse events and/or clinical laboratory abnormalities
timeFrame: Day 28
measure: Number of patients who experience Dose Limiting Toxicities (DLT) as defined in the protocol
timeFrame: Day 28
Secondary outcomes:
measure: Area under the concentration-time curve (AUC) of NXP900
timeFrame: First dose through Day 29
measure: Maximum observed concentration (Cmax) of NXP900
timeFrame: First dose through Day 29
measure: Time to peak concentration (Tmax) of NXP900
timeFrame: First dose through Day 29
measure: Half-life (T1/2) of NXP900
timeFrame: First dose through Day 29
measure: Apparent volume of distribution at steady state (Vss/F) of NXP900
timeFrame: First dose through Day 29
measure: Apparent plasma clearance at steady state (Clss/F) of NXP900
timeFrame: First dose through Day 29
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: Denver
country: United States
facility: Sarah Cannon Research Institute at HealthONE
state: Colorado
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Edinburgh
country: United Kingdom
facility: Western General Hospital - NHS Lothian
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation and Trust
Study officials:
affiliation: Institute of Cancer Research, Royal Marsden NHS Foundation Trust
name: Udai Banerji, Prof
role: PRINCIPAL_INVESTIGATOR
References: