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

Completed · Phase 1

Conditions studied: Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Lung Diseases, Adenocarcinoma

In brief

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.

Key facts

Study ID: NCT02926768
Run by: Checkpoint Therapeutics, Inc.
People needed: 136
Starts: 2016-09-01
Expected to finish: 2022-06-01
Last updated by the study team: 2022-07-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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:
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).

You may not qualify if…

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

Where it is running

Research Site — Sarasota, Florida, United States
Research Site — St Louis, Missouri, United States
Research Site — Hackensack, New Jersey, United States
Research Site — Nashville, Tennessee, United States
Research Site — Greenslopes, Queensland, Australia
Research Site — Grafton, Auckland, New Zealand
Research Site — Christchurch, New Zealand
Research Site — Wellington, New Zealand
Research Site — Poznan, Greater Poland Voivodeship, Poland
Research Site — Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Research Site — Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Research Site — Lublin, Lublin Voivodeship, Poland
Research Site — Bialystok, Podlaskie Voivodeship, Poland
Research Site — Szczecin, West Pomeranian Voivodeship, Poland
Research Site, Pathumwan — Bangkok, Thailand
Research Site, Ratchathewi District — Bangkok, Thailand
Research Site, Bangkok Noi District — Bangkok, Thailand
Research Site, Muang District — Chiang Mai, Thailand
Research Site — Khon Kaen, Thailand
Research Site, Muang — Phitsanulok, Thailand

Full record on ClinicalTrials.gov

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