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

NCT02926768 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2022-07-26

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Checkpoint Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2020-09-30
Completion
2022-06-30

Countries

  • United States
  • Australia
  • New Zealand
  • Poland
  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02926768 on ClinicalTrials.gov