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

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ClinicalTrials.gov Identifier: NCT02926768
Recruitment Status : Recruiting
First Posted : October 6, 2016
Last Update Posted : February 8, 2018
Sponsor:
Information provided by (Responsible Party):
Checkpoint Therapeutics, Inc.

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 previously treated NSCLC patients known to have the T790M EGFR mutation.

Condition or disease Intervention/treatment Phase
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Neoplasms Lung Diseases Adenocarcinoma Advanced Solid Tumors 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 122 participants
Allocation: Non-Randomized
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
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

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





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 ]


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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:

  • Diagnosis with a histologically confirmed non-small cell lung cancer (NSCLC) or other refractory solid tumor that is metastatic or unresectable for which there is no standard curative or palliative treatment option available and where targeting EGFR may be appropriate
  • 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
  • Phase 2 patients must have confirmed EGFR T790M mutation-positive NSCLC

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
  • Phase 2 patients are also excluded if they had prior treatment with CK-101 or other third generation TKIs that target EGFR T790M mutation-positive NSCLC, or have evidence that the tumor harbors an exon 20 insertion mutation

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


Contacts
Contact: Sarah Cannon Research Institute 1-844-482-4812

Locations
United States, Florida
Research Site Recruiting
Sarasota, Florida, United States, 34232
United States, Missouri
Research Site Recruiting
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Research Site Recruiting
Hackensack, New Jersey, United States, 07601
United States, Oklahoma
Research Site Recruiting
Norman, Oklahoma, United States, 73019
United States, Tennessee
Research Site Recruiting
Nashville, Tennessee, United States, 37203
Australia, Queensland
Research Site Recruiting
Greenslopes, Queensland, Australia, 4120
New Zealand
Research Site Recruiting
Grafton, Auckland, New Zealand, 1010
Research Site Recruiting
Christchurch, New Zealand, 8011
Research Site Recruiting
Wellington, New Zealand, 6021
Thailand
Research Site, Pathumwan Recruiting
Bangkok, Thailand, 10330
Research Site, Ratchathewi District Recruiting
Bangkok, Thailand, 10400
Research Site, Bangkok Noi District Recruiting
Bangkok, Thailand, 10700
Research Site, Muang District Recruiting
Chiang Mai, Thailand, 50200
Research Site Recruiting
Khon Kaen, Thailand, 40002
Research Site, Muang Recruiting
Phitsanulok, Thailand, 65000
Sponsors and Collaborators
Checkpoint Therapeutics, Inc.

Responsible Party: Checkpoint Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02926768     History of Changes
Other Study ID Numbers: CK-101-101
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018

Keywords provided by Checkpoint Therapeutics, Inc.:
Cancer
Non Small Cell Lung Cancer
EGFR sensitivity mutation
T790M
NSCLC
epidermal growth factor receptor
EGFR
EGFR inhibitor
Solid Tumors

Additional relevant MeSH terms:
Neoplasms
Adenocarcinoma
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site