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 :
Completed
First Posted : October 6, 2016
Last Update Posted : July 26, 2022
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Condition or disease | Intervention/treatment | Phase |
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Lung Neoplasms Carcinoma, Non-Small-Cell Lung Lung Diseases Adenocarcinoma | Drug: CK-101 | Phase 1 |
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 |
Actual Study Completion Date : | June 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Daily dose of CK-101
Daily oral dose of CK-101
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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 |
- Phase I: Incidence of dose-limiting toxicities (DLTs) [ Time Frame: 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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Histologically or cytologically confirmed diagnosis of one of the following:
- 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
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Metastatic or unresectable locally advanced NSCLC:
- 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
- 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
- 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

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
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 |
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: | July 26, 2022 |
Last Verified: | July 2022 |
Cancer Non Small Cell Lung Cancer EGFR sensitivity mutation T790M |
NSCLC epidermal growth factor receptor EGFR EGFR inhibitor |
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 |