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Phase II Trial of HM61713 for the Treatment of ≥2nd Line T790M Mutation Positive Adenocarcinoma of the Lung | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Phase II Trial of HM61713 for the Treatment of ≥2nd Line T790M Mutation Positive Adenocarcinoma of the Lung

A Single Arm, Open-label, Phase 2 Study Evaluating the Efficacy, Safety and PK of HM61713 in Patients With T790M-positive NSCLC After Treatment With an Epidermal Growth Factor Receptor-tyrosine Kinase Inhibitor

NCT02485652•Hanmi Pharmaceutical Company Limited

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of HM61713 in patients with T790M-positive non-small cell lung cancer (NSCLC) after treatment with an epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI).

Detailed Description

This is a single-arm, open-label, Phase 2 study to assess the anti-tumor efficacy of oral single agent HM61713 administered to patients with T790M-positive NSCLC after treatment with an EGFR-TKI as measured by objective response rate (ORR).

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age: at least 20 years of age
•Cytologically or histologically confirmed adenocarcinoma of locally advanced or metastatic NSCLC which is not amenable to curative surgery or radiotherapy
•Radiologically confirmed disease progression after at least one line of treatment with an EGFR-TKI
•At least one documented EGFR mutation which is known to be related with susceptibility to EGFR-TKIs (including G719X, exon 19 deletion, L858R, and L861Q)
•World Health Organization (WHO) performance score of 0 to 1 with life expectancy of at least 3 months
•Centrally confirmed T790M mutation positive tumor status from a tumor sample taken after confirmation of disease progression on the most recent anticancer treatment regimen
•At least one lesion (excluding the brain), not previously irradiated that can be accurately measured per RECIST version 1.1
•Adequate hematological and biological function
•Females of child-bearing potential must agree to use adequate contraception and for 3 months after the last dose of study drug
•Male patients should be documented to be sterile or agree to use barrier contraception
+1 more criteria

Exclusion Criteria

•Known history of hypersensitivity to active or inactive excipients of HM61713 or drugs with a similar chemical structure of HM61713
•Previous treatment with anticancer therapies, EGFR-TKI, HM61713, or other drugs that target T790M-positive mutant EGFR with sparing of wild-type, investigational agent(s) within 28 days prior to the first administration of study drug, radiotherapy
•Any non-study related significant surgical procedures within the past 28 days prior to the first administration of study drug
•Spinal cord compression, leptomeningeal carcinomatosis or active symptomatic brain metastases
•History of any other malignancy
•Clinically significant uncontrolled condition(s)
•Active or chronic pancreatitis
•Anyone with cardiac abnormalities or history
•Presence or history of ILD, drug-induced ILD, or presence of radiation pneumonitis
•Pregnant or breast feeding
+1 more criteria

Locations (72)

Research Site

Beverly Hills, California, United States

Research Site

Burbank, California, United States

Research Site 2

Los Angeles, California, United States

Research Site

Los Angeles, California, United States

Research Site

Montebello, California, United States

Research Site

Orange, California, United States

Research Site

San Diego, California, United States

Research Site

Boca Raton, Florida, United States

Research Site

Honolulu, Hawaii, United States

Research Site

Evanston, Illinois, United States

Key Dates

Start Date

August 31, 2015

Primary Completion Date

December 8, 2020

Completion Date

December 8, 2020

Last Updated

January 22, 2021

Enrollment

162

ACTUAL participants

Conditions

Non Small Cell Lung Cancer

Interventions

HM61713

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Phase II Trial of HM61713 for the Treatment of ≥2nd Line T790M Mutation Positive Adenocarcinoma of the Lung

Inclusion Criteria

Exclusion Criteria

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

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