A Phase 1, open label, single dose, dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of EARLI-001 in subjects with locally advanced or metastatic lung cancer or subjects with metastases in the lung or liver of a primary cancer origin other than lung cancer

Earli, Pty Ltd0 sites10 target enrollmentNovember 9, 2020

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Earli, Pty Ltd
Enrollment: 10
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 9, 2020

End Date

January 27, 2023

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Earli, Pty Ltd

Eligibility Criteria

Inclusion Criteria

•1\. Signed written informed consent prior to the initiation of any study\-specific procedures.
•2\. Males and females aged 18 years or older at time of consent
•3\. Histologically or cytologically confirmed locally advanced or metastatic lung cancer. Subjects with metastases in the lung or liver of a primary cancer origin other than lung cancer may also be considered for inclusion
•4\. Expected survival greater than 3 months
•5\. Eastern Cooperative Oncology Group (ECOG) performance status of 0\-1
•6\. Body mass index (BMI) less than or equal to 32\.0 kg/m2
•7\. Adequate organ and marrow function based on clinical laboratory assessments
•8\. Female subjects must be of non\-childbearing potential
•9\. Male patients must use highly effective contraception methods consisting of 2 forms of birth control starting at screening and continuing throughout the study period and for 3 months after the last study treatment

Exclusion Criteria

•1\. Females of child\-bearing potential or who are breastfeeding or who have a positive pregnancy test
•2\. Has a known severe hypersensitivity to any of the excipients in the formulation of EARLI\-001\.
•3\. Has a clinically significant history or presence of ECG findings as judged by the PI or designee at screening
•4\. Has received treatment within 30 days or 5 half\-lives (whichever is greater) before dosing for their current diagnosis of histologically or cytologically confirmed locally advanced or metastatic lung cancer or their current diagnosis with metastases in the lung or liver of a primary cancer origin other than lung cancer. Subjects will be permitted to start on an approved treatment after the Day 8 assessments have been completed.
•5\. Has received treatment with another investigational drug, or investigational device, within 30 days or 5 half\-lives (whichever is longer) before dosing.
•6\. Is currently taking heparin, or a heparin analog.
•7\. Has signs or symptoms of organ failure, major chronic illnesses other than cancer, or any concomitant medical or social conditions which, in the opinion of the investigator, make it undesirable for the patient to participate in the study, or which could jeopardize compliance with the protocol.
•8\. Is unable to cooperate fully with the requirements of the study protocol, including the schedule of assessments, or likely to be non\-compliant with any study requirements
•9\. Other unspecified reasons that, in the opinion of the PI or Sponsor, make the patient unsuitable for enrollment.