Phase I/II Trial to Evaluate Safety, Tolerability and Pharmacokinetic Profile of HM61713 in NSCLC Patients

Hanmi Pharmaceutical

Status and phase

Completed

Phase 2

Phase 1

Conditions

Non Small Cell Lung Cancer

Treatments

Drug: HM61713

Study type

Interventional

Funder types

Industry

Identifiers

HM-EMSI-101

Details and patient eligibility

About

The main objective of this study is to evaluate the safety and tolerability of HM61713.

Full description

Besides the main objective, there are 3 other objectives as follows:

To evaluate the anti-cancer effect of HM61713 in NSCLC patients with EGFR mutation
To investigate the pharmacokinetic profile of HM61713 and its metabolites after oral administration
To investigate biomarkers related to the safety and efficacy of HM61713

Enrollment

273 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with histologically or cytologically confirmed diagnosis of advanced NSCLC
Patients with EGFR mutation-positive tumor
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
Estimated life expectancy of at least 12 weeks
Subjects with adequate bone marrow (WBC ≥4,000/mm3, Platelet ≥100,000/mm3, Hemoglobin≥9.0g/dL, ANC≥1,500/mm3), renal (Creatinine≤1.5 mg/dl) and hepatic [aspartate aminotransferase (AST)/ alanine aminotransferase (ALT)/ alkaline phosphatase (ALP)≤3 x ULN, Total bilirubin ≤2.0 mg/dL] function. No significant heart and lung disease.

※ For subjects with a liver metastases, AST/ALT/ALP≤ 5 x ULN is allowed; and for subjects with bone marrow metastases, ALP≤ 5 x ULN is allowed
Patients with amylase level ≤ 1.5 x ULN
Subjects who have provided voluntary consent to participate in the study, and signed the written consent document

Malignancy that has progressed after at least two prior chemotherapy regimens, including EGFR-TKI

Patients with disease progression despite anticancer therapy with EGFR-TKI (e.g., erlotinib, gefitinib, neratinib, afatinib, dacomitinib)
Patients who have provided voluntary consent for collection of tumor tissue taken and archived after the last anticancer therapy or collection of new tissue specimen and signed the written consent document

Patients with disease progression despite anticancer therapy with EGFR TKI (e.g., erlotinib, gefitinib, neratinib, afatinib, dacomitinib) (Except treatment with EGFR mutation selective inhibitor, the same class of drug as investigational drug in this study)
T790M mutation-positive confirmed in tissue collected after PD is confirmed during or after the last anticancer therapy
At least one measurable target lesion allowing repeated measurement according to RECIST ver1.1 as of screening

Patients with disease progression despite anticancer therapy with EGFR TKI (e.g., erlotinib, gefitinib, neratinib, afatinib, dacomitinib) (Except treatment with EGFR mutation selective inhibitor, the same class of drug as investigational drug in this study)
T790M mutation-negative confirmed in tissue collected after progressive disease (PD) is confirmed during or after the last anticancer therapy
At least one measurable target lesion allowing repeated measurement according to RECIST ver1.1 as of screening

Exclusion criteria

Hematologic malignancies
Symptomatic or uncontrolled central nervous system metastases
Interstitial lung disease, including pulmonary fibrosis
LVEF < 40% or NYHA Class III or IV heart failure
History of pancreatitis
History or current evidence, of any psychiatric or congenital disorder, including dementia or epilepsy
Compromised organ function, infection or allergy
Pregnant or breast-feeding women, or women of child-bearing potential who do not use an appropriate method of contraception (male patients should also use an appropriate method of contraception during the study period)
Patients who had received other investigational product within 30 days prior to screening