A Phase 1 Clinical Study of NXP900 in Subjects With Advanced Cancers

Advanced Solid Tumor Clinical Trial

Official title:

A Phase 1 Clinical Study of NXP900 in Subjects With Advanced Cancers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05873686
• Other study ID #: NXP900-101
• Status: Recruiting
• Phase: Phase 1
• Start date: October 26, 2023
• Est. completion date: January 2025

Study information

• Verified date: October 2023
• Source: Nuvectis Pharma, Inc.
• Contact: Diane Marsolini
• Phone: (201) 627-8154
• Email: dmarsolini[@]nuvectis.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this dose escalation study is to evaluate the safety profile of escalating doses and dose schedules of NXP900.

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 information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor

Intervention

Drug:
• NXP900
NXP900 is an orally administered SRC/YES1 kinase inhibitor

Locations

Country	Name	City	State
United Kingdom	Ward 1 - Edinburgh Cancer Centre, Western General Hospital	Edinburgh
United Kingdom	The Royal Marsden NHS Foundation and Trust	London
United States	Sarah Cannon Research Institute at HealthONE	Denver	Colorado
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Mayo Clinic	Jacksonville	Florida
United States	Mayo Clinic	Phoenix	Arizona
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Nuvectis Pharma, Inc.

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with treatment related adverse events and/or clinical laboratory abnormalities		Day 28
Primary	Number of patients who experience Dose Limiting Toxicities (DLT) as defined in the protocol		Day 28
Secondary	Area under the concentration-time curve (AUC) of NXP900		First dose through Day 29
Secondary	Maximum observed concentration (Cmax) of NXP900		First dose through Day 29
Secondary	Time to peak concentration (Tmax) of NXP900		First dose through Day 29
Secondary	Half-life (T1/2) of NXP900		First dose through Day 29
Secondary	Apparent volume of distribution at steady state (Vss/F) of NXP900		First dose through Day 29
Secondary	Apparent plasma clearance at steady state (Clss/F) of NXP900		First dose through Day 29