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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02926768
Recruitment Status : Active, not recruiting
First Posted : October 6, 2016
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
Checkpoint Therapeutics, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Lung Diseases Adenocarcinoma Drug: CK-101 Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II, Open-Label, Safety, Pharmacokinetic and Efficacy Study of Ascending Doses of Oral CK-101 in Patients With Advanced Solid Tumors
Actual Study Start Date : September 2016
Actual Primary Completion Date : September 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Phase I: Incidence of dose-limiting toxicities (DLTs) [ Time Frame: From baseline (first dose) to 28 days after last dose, expected average 6 months ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02926768


Locations
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United States, Florida
Research Site
Sarasota, Florida, United States, 34232
United States, Missouri
Research Site
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Research Site
Hackensack, New Jersey, United States, 07601
United States, Tennessee
Research Site
Nashville, Tennessee, United States, 37203
Australia, Queensland
Research Site
Greenslopes, Queensland, Australia, 4120
New Zealand
Research Site
Grafton, Auckland, New Zealand, 1010
Research Site
Christchurch, New Zealand, 8011
Research Site
Wellington, New Zealand, 6021
Poland
Research Site
Bydgoszcz, Kujawsko-Pomorskie, Poland, 85-231
Research Site
Bydgoszcz, Kujawsko-Pomorskie, Poland, 85-796
Research Site
Lublin, Lubelskie, Poland, 20-064
Research Site
Białystok, Podlaskie, Poland, 15-044
Research Site
Poznań, Wielkopolskie, Poland, 60-693
Research Site
Szczecin, Zachodniopomorskie, Poland, 70-784
Thailand
Research Site, Pathumwan
Bangkok, Thailand, 10330
Research Site, Ratchathewi District
Bangkok, Thailand, 10400
Research Site, Bangkok Noi District
Bangkok, Thailand, 10700
Research Site, Muang District
Chiang Mai, Thailand, 50200
Research Site
Khon Kaen, Thailand, 40002
Research Site, Muang
Phitsanulok, Thailand, 65000
Sponsors and Collaborators
Checkpoint Therapeutics, Inc.
More Information
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Responsible Party: Checkpoint Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02926768    
Other Study ID Numbers: CK-101-101
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Keywords provided by Checkpoint Therapeutics, Inc.:
Cancer
Non Small Cell Lung Cancer
EGFR sensitivity mutation
T790M
 NSCLC
epidermal growth factor receptor
EGFR
EGFR inhibitor
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Lung Diseases
Neoplasms
Respiratory Tract Diseases
 Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site