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

NCT ID: NCT02442414

Last Updated: 2022-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-07
• Study Completion Date: 2019-11-26

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.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

KBP-5209

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.

Group Type: EXPERIMENTAL

KBP-5209

Intervention Type: DRUG

Single oral dose beginning at 20 mg with daily dosing for 28 day cycles.

Interventions

KBP-5209

Single oral dose beginning at 20 mg with daily dosing for 28 day cycles.

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Covance

INDUSTRY

Sponsor Role: collaborator

XuanZhu Pharma Co., Ltd.

UNKNOWN

Sponsor Role: collaborator

Sihuan Pharmaceutical Holdings Group Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah, United States

Countries

United States

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: DERIVED

PMID: 29954840 (View on PubMed)

Other Identifiers

5209-CPK-1001

Identifier Type: -

Identifier Source: org_study_id