CompletedPhase 1NCT02442414

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

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.

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

StatusCompleted
PhasePhase 1
U.S. locations3
SponsorSihuan Pharmaceutical Holdings Group Ltd.
01
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
02
Explore related studies

How this study is categorized

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

03
Public criteria

Who may be able to participate

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;

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

04
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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