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

Phase 1

Recruiting

• Conditions: Advanced Solid Tumor
• Interventions: Drug: NXP900

• 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.

Study Timeline

• Study First Submitted: 2023-05-15
• Study First Submitted QC: 2023-05-15
• Study First Posted: 2023-05-24
• Study Start: 2023-10-26
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21
• Primary Completion: 2025-01
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

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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.

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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

Ward 1 - Edinburgh Cancer Centre, Western General Hospital; 🇬🇧 Edinburgh, United Kingdom

The Royal Marsden NHS Foundation and Trust; 🇬🇧 London, United Kingdom