NCT02926768

Phase I/II Study of CK-101 in NSCLC Patients and Other Advanced Solid Tumors

A Phase I/II, Open-Label, Safety, Pharmacokinetic and Efficacy Study of Ascending Doses of Oral CK-101 in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Checkpoint Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

CK-101 is a novel, potent, small molecule tyrosine kinase inhibitor (TKI) that selectively targets mutant forms of the epidermal growth factor receptor (EGFR) while sparing wild-type (WT) EGFR. The purpose of the study is to evaluate the pharmacokinetic (PK) and safety profile of oral CK-101; to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of oral CK-101; to assess the safety and efficacy of CK-101 in treatment-naive NSCLC patients known to have activating EGFR mutations and previously treated NSCLC patients known to have the T790M EGFR mutation.

Detailed description

This is a first-in-human, two-part, open-label, safety, pharmacokinetic, and efficacy study of oral CK-101 administered daily in ascending doses in patients with advanced solid tumor cancer, followed by a Phase 2 portion at the recommended Phase 2 dose (RP2D) in previously treated non-small cell lung cancer (NSCLC) patients who have documented evidence of EGFR T790M mutation and have failed treatment with a first-line EGFR inhibitor.

Conditions

• Lung Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Lung Diseases
• Adenocarcinoma

Interventions

Type	Name	Description
DRUG	CK-101	Phase 1: CK-101 will be administered in escalating dosages in a period of 21-day cycles Phase 2: CK-101 will be administered daily

Timeline

• Start date: 2016-09-01
• Primary completion: 2020-09-01
• Completion: 2022-06-01
• First posted: 2016-10-06
• Last updated: 2022-07-26

Locations

20 sites across 5 countries: United States, Australia, New Zealand, Poland, Thailand