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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_1

Timeline

Completed

Started Apr 2015

Longer than P75 for phase_1

Geographic Reach

1 country

3 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.6 years study duration

Study Start

First participant enrolled

April 7, 2015

Completed

22 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2015

Completed

14 days until next milestone

First Posted

Study publicly available on registry

May 13, 2015

Completed

4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2019

Completed

Last Updated

March 4, 2022

Status Verified

February 1, 2022

Enrollment Period

4.6 years

First QC Date

April 29, 2015

Last Update Submit

February 17, 2022

Conditions

Advanced Solid Tumors

Keywords

CancerAdvanced Solid TumorsEGFRHER2HER3HER4ALK mutationsirreversible tyrosine kinase inhibitorMetastatic Non Small Cell Lung CancerGastric CancerColorectal Cancer

Outcome Measures

Primary Outcomes (1)

Outcome Measure: safety and tolerability, based on the rate of dose-limiting toxicities, toxicity grade, and reversibility of toxicity.
2 Years

Secondary Outcomes (1)

Dose-dependency of toxicity based on: dose limiting toxicities; frequency, type, grade, and seriousness, and causality of treatment-emergent adverse events, and laboratory assessments.
While undergoing study treatment and up to 30 days after the last dose of KBP-5209

Study Arms (1)

KBP-5209

EXPERIMENTAL

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.

Drug: KBP-5209

Interventions

KBP-5209DRUG

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

KBP-5209

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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;

You may not qualify if:

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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Sihuan Pharmaceutical Holdings Group Ltd.lead
Covancecollaborator
XuanZhu Pharma Co., Ltd.collaborator

Study Sites (3)

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Related Publications (6)

Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55. No abstract available.
PMID: 7165009BACKGROUND
Simon R, Freidlin B, Rubinstein L, Arbuck SG, Collins J, Christian MC. Accelerated titration designs for phase I clinical trials in oncology. J Natl Cancer Inst. 1997 Aug 6;89(15):1138-47. doi: 10.1093/jnci/89.15.1138.
PMID: 9262252BACKGROUND
Gibaldi M, Perrier D. Pharmacokinetics. 2nd edition. New York, NY: Marcel Dekker, Inc.; 1982.
BACKGROUND
ICH E3: Guideline for Industry: Structure and Content of Clinical Study Reports. 1996.
BACKGROUND
Jaiswal BS, Kljavin NM, Stawiski EW, Chan E, Parikh C, Durinck S, Chaudhuri S, Pujara K, Guillory J, Edgar KA, Janakiraman V, Scholz RP, Bowman KK, Lorenzo M, Li H, Wu J, Yuan W, Peters BA, Kan Z, Stinson J, Mak M, Modrusan Z, Eigenbrot C, Firestein R, Stern HM, Rajalingam K, Schaefer G, Merchant MA, Sliwkowski MX, de Sauvage FJ, Seshagiri S. Oncogenic ERBB3 mutations in human cancers. Cancer Cell. 2013 May 13;23(5):603-17. doi: 10.1016/j.ccr.2013.04.012.
PMID: 23680147BACKGROUND
Li M, Liu F, Zhang F, Zhou W, Jiang X, Yang Y, Qu K, Wang Y, Ma Q, Wang T, Bai L, Wang Z, Song X, Zhu Y, Yuan R, Gao Y, Liu Y, Jin Y, Li H, Xiang S, Ye Y, Zhang Y, Jiang L, Hu Y, Hao Y, Lu W, Chen S, Gu J, Zhou J, Gong W, Zhang Y, Wang X, Liu X, Liu C, Liu H, Liu Y, Liu Y. Genomic ERBB2/ERBB3 mutations promote PD-L1-mediated immune escape in gallbladder cancer: a whole-exome sequencing analysis. Gut. 2019 Jun;68(6):1024-1033. doi: 10.1136/gutjnl-2018-316039. Epub 2018 Jun 28.
PMID: 29954840DERIVED

MeSH Terms

Conditions

NeoplasmsCarcinoma, Non-Small-Cell LungStomach NeoplasmsColorectal Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesIntestinal NeoplasmsColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 29, 2015

First Posted

May 13, 2015

Study Start

April 7, 2015

Primary Completion

November 26, 2019

Study Completion

November 26, 2019

Last Updated

March 4, 2022

Record last verified: 2022-02

Locations

US(3)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

KBP-5209

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (3)

Related Publications (6)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

Locations