A Phase 1 Study of KBP-5209 in Patients With Advanced Solid Tumors

Study Overview
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Brief Summary
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The purpose of this study is to determine the maximum tolerated dose of KBP-5209 as a single agent when given orally to adult patients with advanced solid tumors that have progressed despite standard therapy, or where there is no standard therapy.

Detailed Description
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This is a Phase 1, open-label, multicenter study of KBP-5209 administered orally once daily (QD) in 28-day treatment cycles to adult patients with advanced solid tumors which have progressed despite standard therapy or for which no standard therapy exists. This study is designed to determine the MTD or RP2D and to characterize the safety, tolerability, and PK profile of KBP-5209.

Conditions
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Advanced Solid Tumors

Intervention / Treatment
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* Drug: KBP-5209


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older; Patients with histologically or cytologically confirmed, advanced solid tumors which have progressed despite standard therapy or for whom no standard therapy exists. Patients must have at least one measurable or non-measurable lesion (dose escalation only) as defined by RECIST v1.1 Eastern Cooperative Oncology Group performance score 0 to 2; Exclusion Criteria: Patients with symptomatic CNS metastases; Patients who have a known history of hepatitis C or chronic active hepatitis B or a known diagnosis of HIV Any significant ophthalmologic abnormality Patients who have any severe and/or uncontrolled medical conditions Significant gastrointestinal abnormalities, Patients who have impaired cardiac function or clinically significant cardiac diseases, Chemotherapy, biologic therapy, immunotherapy, radiotherapy or investigational agents within 5 half-lives or within 4 weeks (whichever is longer) prior to administration of the first dose of study drug on Day 1 or have not recovered from the side effects of such therapy; Treatment with third generation EGFR inhibitors Major surgery/surgical therapy for any cause within 4 weeks of Screening;

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KBP-5209<br>Dose escalation for KBP-5209 will initially follow a modified accelerated titration design with a starting dose of 20 mg QD. Early dose escalation will proceed with one-patient cohorts and 100% dose increments (ie, dose doubling) until a patient experiences a DLT, at which point the cohorts will move to a 3+3 design. Treatment will continue until there appears evidence of progressive disease, intolerable toxicity, or the subject discontinues from the study treatment for other reasons. A cycle is defined as continuous treatment for 28 days. | Drug: KBP-5209<br>* Single oral dose beginning at 20 mg with daily dosing for 28 day cycles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome Measure: safety and tolerability, based on the rate of dose-limiting toxicities, toxicity grade, and reversibility of toxicity. |  | 2 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-dependency of toxicity based on: dose limiting toxicities; frequency, type, grade, and seriousness, and causality of treatment-emergent adverse events, and laboratory assessments. |  | While undergoing study treatment and up to 30 days after the last dose of KBP-5209 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Advanced Solid Tumors, EGFR, HER2, HER3, HER4, ALK mutations, irreversible tyrosine kinase inhibitor, Metastatic Non Small Cell Lung Cancer, Gastric Cancer, Colorectal Cancer