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

Study 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).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedHM61713

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · EGFR

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jan 22, 2021 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?72 U.S. locations

Locations may change over time.

Who runs it?Hanmi Pharmaceutical Company Limited

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Hanmi Pharmaceutical Company Limited
Interventions being studied: Drug: HM61713

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How this study is categorized

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

Cancer type

Non-small cell lung cancer (NSCLC)→

Biomarkers

EGFR→

Treatment approach

Targeted therapy→

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: 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
Recovery to ≤ Grade 1 or baseline of any toxicities, except for stable sensory neuropathy ≤ Grade 2 and alopecia

Reasons someone may not be able to joinExclusion 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
In the opinion of the investigator, the patient is an unsuitable candidate to receive HM61713

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

Research SiteBeverly Hills, California
Research SiteBurbank, California
Research Site 2Los Angeles, California
Research SiteLos Angeles, California
Research SiteMontebello, California
Research SiteOrange, California
Research SiteSan Diego, California
Research SiteBoca Raton, Florida
Research SiteHonolulu, Hawaii
Research SiteEvanston, Illinois
Research SiteBethesda, Maryland
Research SiteBoston, Massachusetts

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 22, 2021. Always confirm current availability with the study team.

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