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

Sihuan Pharmaceutical Group

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: KBP-5209

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT02442414

5209-CPK-1001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

KBP-5209

Experimental group

Description:

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.

Treatment:

Drug: KBP-5209