Advanced Solid Tumors
Conditions
Keywords
Cancer, Advanced Solid Tumors, EGFR, HER2, HER3, HER4, ALK mutations, irreversible tyrosine kinase inhibitor, Metastatic Non Small Cell Lung Cancer, Gastric Cancer, Colorectal Cancer
Brief summary
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
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.
Interventions
DRUGKBP-5209
Single oral dose beginning at 20 mg with daily dosing for 28 day cycles.
Sponsors
Covance
XuanZhu Pharma Co., Ltd.
Sihuan Pharmaceutical Holdings Group Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome Measure: safety and tolerability, based on the rate of dose-limiting toxicities, toxicity grade, and reversibility of toxicity. | 2 Years |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed