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

July 25, 2022 updated by: Checkpoint Therapeutics, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
136

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Greenslopes, Queensland, Australia, 4120
        • Research Site
  • New Zealand
      • Christchurch, New Zealand, 8011
        • Research Site
      • Wellington, New Zealand, 6021
        • Research Site
    • Auckland
      • Grafton, Auckland, New Zealand, 1010
        • Research Site
  • Poland
    • Kujawsko-Pomorskie
      • Bydgoszcz, Kujawsko-Pomorskie, Poland, 85-231
        • Research Site
      • Bydgoszcz, Kujawsko-Pomorskie, Poland, 85-796
        • Research Site
    • Lubelskie
      • Lublin, Lubelskie, Poland, 20-064
        • Research Site
    • Podlaskie
      • Białystok, Podlaskie, Poland, 15-044
        • Research Site
    • Wielkopolskie
      • Poznań, Wielkopolskie, Poland, 60-693
        • Research Site
    • Zachodniopomorskie
      • Szczecin, Zachodniopomorskie, Poland, 70-784
        • Research Site
  • Thailand
      • Bangkok, Thailand, 10330
        • Research Site, Pathumwan
      • Bangkok, Thailand, 10400
        • Research Site, Ratchathewi District
      • Bangkok, Thailand, 10700
        • Research Site, Bangkok Noi District
      • Chiang Mai, Thailand, 50200
        • Research Site, Muang District
      • Khon Kaen, Thailand, 40002
        • Research Site
      • Phitsanulok, Thailand, 65000
        • Research Site, Muang
  • United States
    • Florida
      • Sarasota, Florida, United States, 34232
        • Research Site
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Research Site
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Research Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Measureable disease according to RECIST Version 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Minimum age of 18 years
  • Adequate hematological, hepatic and renal function
  • Written consent on an Institutional Review Board-approved informed consent form prior to any study-specific evaluation

  • Histologically or cytologically confirmed diagnosis of one of the following:

    1. Metastatic or unresectable locally advanced NSCLC with documented evidence that the tumor harbors one of the two common EGFR mutations known to be associated with EGFR tyrosine kinase inhibitor (TKI) sensitivity (exon 19 deletion, L858R), either alone or in combination with other EGFR mutations, determined by PCR-based testing of the tumor tissue or plasma sample, and without prior exposure to an EGFR-TKI therapy; OR

    2. Metastatic or unresectable locally advanced NSCLC:

      1. with documented evidence that the tumor harbors an EGFR mutation known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q); and
      2. with evidence of radiological disease progression while on a previous continuous treatment with a first-generation EGFR TKI. In addition, other lines of therapy may have been given. All patients must have evidence of radiological disease progression on or following the last treatment administered; and
      3. with documented evidence of EGFR T790M mutation determined by PCR-based testing of the tumor tissue or plasma sample following disease progression on most recent treatment regimen (irrespective of whether this is EGFR TKI or chemotherapy).

Exclusion Criteria:

  • Active second malignancy or other prior malignancy treated with chemotherapy less than or equal to 6 months prior to treatment with CK-101
  • History of, or evidence of clinically active, interstitial lung disease
  • Brain metastases unless asymptomatic, stable and not requiring steroids for at least 2 weeks
  • Treatment with prohibited medications
  • Any toxicity related to prior treatment must have resolved to Grade 1 or less, with the exception of alopecia and Grade 2, prior platinum-therapy related neuropathy
  • Certain cardiac abnormalities or history
  • Non-study related surgical procedures less than or equal to 14 days prior to CK-101 administration
  • Females who are pregnant or breastfeeding.
  • Refusal to use adequate contraception for fertile patients (females and males)
  • Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study
  • Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Daily dose of CK-101
Daily oral dose of CK-101
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Phase I: Incidence of dose-limiting toxicities (DLTs)
Time Frame: From baseline (first dose) to 28 days after last dose, expected average 6 months
From baseline (first dose) to 28 days after last dose, expected average 6 months
Phase II: Objective response rate (ORR): Defined as the rate of complete responses [CR] or partial responses [PR] per RECIST Version 1.1 as assessed by an independent central review
Time Frame: From baseline (first dose) until disease progression or withdrawal from study, expected average 10 months
From baseline (first dose) until disease progression or withdrawal from study, expected average 10 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Phase II: Evaluation of tumor response based on disease control rate as assessed by RECIST 1.1
Time Frame: From baseline (first dose) until disease progression or withdrawal from study, expected average 10 months
From baseline (first dose) until disease progression or withdrawal from study, expected average 10 months
Phase II: Evaluation of tumor response based on duration of response as assessed by RECIST 1.1
Time Frame: From baseline (first dose) until disease progression or withdrawal from study, expected average 10 months
From baseline (first dose) until disease progression or withdrawal from study, expected average 10 months
Phase II: Evaluation of tumor response based on tumor shrinkage as assessed by RECIST 1.1
Time Frame: From baseline (first dose) until disease progression or withdrawal from study, expected average 10 months
From baseline (first dose) until disease progression or withdrawal from study, expected average 10 months
Phase II: Evaluation of tumor response based on progression free survival as assessed by RECIST 1.1
Time Frame: From baseline (first dose) until disease progression or withdrawal from study, expected average 10 months
From baseline (first dose) until disease progression or withdrawal from study, expected average 10 months
Phase I: Change from baseline in QT/QTc interval
Time Frame: Cycle 1 Day 1 until disease progression or withdrawal from study, expected average 10 months
Cycle 1 Day 1 until disease progression or withdrawal from study, expected average 10 months
Phase I: Plasma concentrations of CK-101 following dosing with CK-101 as assessed by area under the curve
Time Frame: Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycle 2
Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycle 2
Phase I: Plasma concentrations of CK-101 following dosing with CK-101 as assessed by maximum concentration
Time Frame: Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycle 2
Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycle 2
Phase I: Plasma concentrations of CK-101 following dosing with CK-101 as assessed by elimination half-life
Time Frame: Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycle 2
Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycle 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Checkpoint Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CK-101-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings