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

Conditions:Lung Cancer, Lung Cancer, Cancer, Cancer, Cancer, Pulmonary
Therapuetic Areas:Oncology, Pulmonary / Respiratory Diseases
Age Range:18 - Any
Start Date:September 2016
End Date:December 2020
Contact:Sarah Cannon Research Institute

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

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.

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

- 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

- 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
We found this trial at
Nashville, TN
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Hackensack, NJ
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Saint Louis, MO
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Sarasota, FL
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