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CK-101

Phase 1

Lung Neoplasms | Small molecule | Oncology |Fortress Biotech, Inc.|Trials Updated: Jul 26, 2022

CK-101 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Oct 2016

CK-101 target and mechanism

Molecular targetEGFR
Target classReceptor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment136

FDA Designations

No designations recorded

CK-101 clinical trials

CK-101 · 1 trial · 4 indications

Phase 1 1
NCT02926768Phase I/II Study of CK-101 in NSCLC Patients and Other Advanced Solid TumorsLung Neoplasms
COMPLETED136 Analytics
PHASE1COMPLETED
Phase I/II Study of CK-101 in NSCLC Patients and Other Advanced Solid Tumors
Lung NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Daily dose of CK-101EXPERIMENTALDaily oral dose of CK-101

Interventions

NameTypeDescription
CK-101DRUGPhase 1: CK-101 will be administered in escalating dosages in a period of 21-day cycles Phase 2: CK-101 will be administered daily
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites20

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 cons...

Countries:United StatesAustraliaNew ZealandPolandThailand
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Frequently asked questions about CK-101

What is CK-101?

CK-101 is an investigational small molecule drug being developed by Fortress Biotech, Inc. for lung neoplasms, specifically non-small-cell lung cancer and other advanced solid tumors. It is designed to target EGFR, a receptor that is a biomarker-selected target in this program. CK-101 remains in clinical development and is not approved for commercial use.

What is CK-101 used for in lung neoplasms?

CK-101 is being studied for the treatment of lung neoplasms, including non-small-cell lung cancer and adenocarcinoma, as well as other advanced solid tumors. The program enrolls patients whose tumors are biomarker-selected for EGFR. It is an investigational therapy and has not been approved for any indication.

What does CK-101 target?

CK-101 targets EGFR, a receptor tyrosine kinase. EGFR is a receptor-class molecular target, and the CK-101 clinical program is biomarker-selected, meaning patients are chosen based on EGFR-related tumor characteristics. This targeted approach is intended to focus treatment on tumors driven by EGFR signaling.

Who is developing CK-101?

CK-101 is being developed by Fortress Biotech, Inc., which trades on the Nasdaq under the ticker FBIO. Fortress Biotech is the sponsor of the CK-101 clinical program in lung neoplasms and other advanced solid tumors.

What phase is CK-101 in?

CK-101 is in Phase 1 clinical development. It is an investigational small molecule and has not been approved by the FDA or any other regulatory agency. The single registered trial for CK-101 has been completed, and no trials are currently listed as active.

What clinical trials is CK-101 in?

CK-101 has been evaluated in one registered clinical trial, NCT02926768, titled Phase I/II Study of CK-101 in NSCLC Patients and Other Advanced Solid Tumors. The trial enrolled 136 patients across the United States, Australia, New Zealand, Poland, and Thailand, and its status is completed. It was an uncontrolled study without randomization or double blinding.