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

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

Detailed Description
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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.

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

Conditions
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Advanced Solid Tumor

Intervention / Treatment
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* Drug: NXP900


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Interventional Model Description: Sequential assignment, dose escalation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose Escalation<br>Escalating doses of NXP900 are planned with a starting dose level of 20 mg once per day. | Drug: NXP900<br>* NXP900 is an orally administered SRC/YES1 kinase inhibitor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration-time curve (AUC) of NXP900 |  | First dose through Day 29 | 
| Maximum observed concentration (Cmax) of NXP900 |  | First dose through Day 29 | 
| Time to peak concentration (Tmax) of NXP900 |  | First dose through Day 29 | 
| Half-life (T1/2) of NXP900 |  | First dose through Day 29 | 
| Apparent volume of distribution at steady state (Vss/F) of NXP900 |  | First dose through Day 29 | 
| Apparent plasma clearance at steady state (Clss/F) of NXP900 |  | First dose through Day 29 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Solid Tumor, Carcinoma, Neoplasms, Adenocarcinoma