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CK-101

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment136

FDA Designations

No designations recorded

Clinical trial landscape

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 used for?

CK-101 is an investigational small molecule being studied for the treatment of lung neoplasms, including non-small-cell lung cancer and adenocarcinoma. It is in Phase 1 clinical development for these oncology indications.

What does CK-101 target?

The molecular target of CK-101 has not been disclosed. It is a small molecule in development for lung neoplasms, but its specific mechanism of action is not publicly specified in available clinical trial information.

Who makes CK-101?

CK-101 is being developed by Fortress Biotech, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol FBIO.

What phase is CK-101 in?

CK-101 is in Phase 1 clinical development. A Phase I/II study has been completed, but the drug remains investigational and has not been approved by regulatory authorities.

What clinical trials is CK-101 in?

CK-101 has been studied in one completed clinical trial, NCT02926768, a Phase I/II study in patients with non-small-cell lung cancer and other advanced solid tumors. The trial enrolled 136 participants across the United States, Australia, New Zealand, Poland, and Thailand.