Lung NeoplasmsPhase 1NCT02926768
Phase I/II Study of CK-101 in NSCLC Patients and Other Advanced Solid Tumors
A Phase 1 study testing CK-101 in people with Lung Neoplasms and Carcinoma, Non-Small-Cell Lung, run by Checkpoint Therapeutics, Inc. at 20 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Lung Diseases
- What is being tested?
- CK-101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 20 sitesin 5 countries
- Study dates
- Sep 2016to Jun 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
- 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).
Who cannot join
- 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
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- 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
Trial locations and contacts
20 sites in 5 countries.
20 sites in 5 countries
Poland6 sites
Research Site
Bialystok, Podlaskie Voivodeship, 15-044
Research Site
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-231
Research Site
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796
Research Site
Lublin, Lublin Voivodeship, 20-064
Research Site
Poznan, Greater Poland Voivodeship, 60-693
Research Site
Szczecin, West Pomeranian Voivodeship, 70-784
Thailand6 sites
Research Site, Pathumwan
Bangkok, 10330
Research Site, Ratchathewi District
Bangkok, 10400
Research Site, Bangkok Noi District
Bangkok, 10700
Research Site, Muang District
Chiang Mai, 50200
Research Site
Khon Kaen, 40002
Research Site, Muang
Phitsanulok, 65000
United States4 sites
Research Site
Hackensack, New Jersey, 07601
Research Site
Nashville, Tennessee, 37203
Research Site
Sarasota, Florida, 34232
Research Site
St Louis, Missouri, 63110
New Zealand3 sites
Research Site
Christchurch, 8011
Research Site
Grafton, Auckland, 1010
Research Site
Wellington, 6021
About this study
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
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.
Read the 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.
- Being tested
- CK-101
- Keywords
- Cancer, Non Small Cell Lung Cancer, EGFR sensitivity mutation, T790M, NSCLC, epidermal growth factor receptor, EGFR, EGFR inhibitor
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Lung Diseases, Adenocarcinoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CK-101Drug
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
| Study group | Role | What they receive |
|---|---|---|
| Daily dose of CK-101 | Experimental | Daily oral dose of CK-101 Receives: Drug: CK-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Incidence of dose-limiting toxicities (DLTs)
Measured: 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
Measured: From baseline (first dose) until disease progression or withdrawal from study, expected average 10 months
Secondary outcomes (8)
Phase II: Evaluation of tumor response based on disease control rate as assessed by RECIST 1.1
Measured: 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
Measured: 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
Measured: 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
Measured: From baseline (first dose) until disease progression or withdrawal from study, expected average 10 months
Phase I: Change from baseline in QT/QTc interval
Measured: 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
Measured: 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
Measured: 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
Measured: Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycle 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2020
- Study completionJun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Checkpoint Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926768
- Sponsor's protocol ID
- CK-101-101
- Status last verified
- Jul 2022
- First submitted
- 29 Sep 2016
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02926768
- Acronym / sponsor ID
- CK-101-101
- Keywords
- Cancer, Non Small Cell Lung Cancer, EGFR sensitivity mutation, T790M, NSCLC, epidermal growth factor receptor, EGFR, EGFR inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Checkpoint Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2016 (actual)
- Primary completion
- Sep 2020 (actual)
- Study completion
- Jun 2022 (actual)
- First posted
- 6 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daily dose of CK-101 | Experimental | Drug: CK-101Daily oral dose of CK-101 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CK-101Phase 1: CK-101 will be administered in escalating dosages in a period of 21-day cycles Phase 2: CK-101 will be administered daily | Drug | Daily dose of CK-101 |
Primary outcome
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
8 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CK-101 in people with Lung Neoplasms and Carcinoma, Non-Small-Cell Lung, run by Checkpoint Therapeutics, Inc. at 20 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Poland, Thailand, United States, New Zealand, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: Incidence of dose-limiting toxicities (DLTs) (time frame: From baseline (first dose) to 28 days after last dose, expected average 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.