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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedKBP-5209

The study team can explain what participation involves.

Who it may be forAdvanced Solid Tumors

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 4, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?3 U.S. locations

Locations may change over time.

Who runs it?Sihuan Pharmaceutical Holdings Group Ltd.

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Sihuan Pharmaceutical Holdings Group Ltd.
Interventions being studied: Drug: KBP-5209

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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;

Reasons someone may not be able to joinExclusion 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;

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana
University of Texas MD Anderson Cancer CenterHouston, Texas
University of Utah Huntsman Cancer InstituteSalt Lake City, Utah

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 4, 2022. Always confirm current availability with the study team.

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