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

NCT02926768 | Completed Phase 1

• 1 other identifier: CK-101-101
• Study Type: interventional
• Target: 136
• Locations: 5 countries
• Sites: 20

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 treatment-naive NSCLC patients known to have activating EGFR mutations and previously treated NSCLC patients known to have the T790M EGFR mutation.

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Lung Diseases; Adenocarcinoma

Keywords

Cancer; Non Small Cell Lung Cancer; EGFR sensitivity mutation; T790M; NSCLC; epidermal growth factor receptor; EGFR; EGFR inhibitor

Outcome Measures

Primary Outcomes (2)

• Phase I: Incidence of dose-limiting toxicities (DLTs)

  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

  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

  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

  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

  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

  From baseline (first dose) until disease progression or withdrawal from study, expected average 10 months

• Phase I: Change from baseline in QT/QTc interval

  Cycle 1 Day 1 until disease progression or withdrawal from study, expected average 10 months

Study Arms (1)

Daily dose of CK-101

EXPERIMENTAL

Daily oral dose of CK-101

Drug: CK-101

Interventions

CK-101 DRUG

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

Daily dose of CK-101

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Checkpoint Therapeutics, Inc.: lead

Study Sites (20)

Research Site

Sarasota, Florida, 34232, United States

Location

Research Site

St Louis, Missouri, 63110, United States

Location

Research Site

Hackensack, New Jersey, 07601, United States

Location

Research Site

Nashville, Tennessee, 37203, United States

Location

Research Site

Greenslopes, Queensland, 4120, Australia

Location

Research Site

Grafton, Auckland, 1010, New Zealand

Location

Research Site

Christchurch, 8011, New Zealand

Location

Research Site

Wellington, 6021, New Zealand

Location

Research Site

Poznan, Greater Poland Voivodeship, 60-693, Poland

Location

Research Site

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-231, Poland

Location

Research Site

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

Location

Research Site

Lublin, Lublin Voivodeship, 20-064, Poland

Location

Research Site

Bialystok, Podlaskie Voivodeship, 15-044, Poland

Location

Research Site

Szczecin, West Pomeranian Voivodeship, 70-784, Poland

Location

Research Site, Pathumwan

Bangkok, 10330, Thailand

Location

Research Site, Ratchathewi District

Bangkok, 10400, Thailand

Location

Research Site, Bangkok Noi District

Bangkok, 10700, Thailand

Location

Research Site, Muang District

Chiang Mai, 50200, Thailand

Location

Research Site

Khon Kaen, 40002, Thailand

Location

Research Site, Muang

Phitsanulok, 65000, Thailand

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Lung Diseases; Adenocarcinoma; Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2016
• First Posted: October 6, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2020
• Study Completion: June 1, 2022
• Last Updated: July 26, 2022

Record last verified: 2022-07

Locations

PL (6); TH (6); AU (1); NZ (3); US (4)