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

• Status: Terminated
• Trial end date: 2020-12-08
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Criteria

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

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

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

• In the opinion of the investigator, the patient is an unsuitable candidate to receive HM61713