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KBP-5209 for Solid Tumors

Phase 1
Waitlist Available
Research Sponsored by Sihuan Pharmaceutical Holdings Group Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Outcome Measure: safety and tolerability, based on the rate of dose-limiting toxicities, toxicity grade, and reversibility of toxicity.
Secondary study objectives
Dose-dependency of toxicity based on: dose limiting toxicities; frequency, type, grade, and seriousness, and causality of treatment-emergent adverse events, and laboratory assessments.

Trial Design

1Treatment groups
Experimental Treatment
Group I: KBP-5209Experimental Treatment1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
KBP-5209
2015
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

CovanceIndustry Sponsor
119 Previous Clinical Trials
12,783 Total Patients Enrolled
Sihuan Pharmaceutical Holdings Group Ltd.Lead Sponsor
22 Previous Clinical Trials
2,612 Total Patients Enrolled
XuanZhu Pharma Co., Ltd.UNKNOWN
~3 spots leftby Sep 2025
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