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CK-301

Phase 1

Lung Neoplasms | Small molecule | Oncology |Fortress Biotech, Inc.|Last Updated: Feb 3, 2025

Target and mechanism

Molecular targetPD-L1
Target classProtein
ModalitySmall molecule

Also known as CK-301 (cosibelimab)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment272

FDA Designations

No designations recorded

Clinical trial landscape

CK-301 · 1 trial · 13 indications

Phase 1 1
NCT03212404Phase 1 Study of CK-301 (Cosibelimab) as a Single Agent in Subjects With Advanced CancersLung Neoplasms
ACTIVE NOT_RECRUITING272 Analytics
PHASE1ACTIVE NOT_RECRUITING
Phase 1 Study of CK-301 (Cosibelimab) as a Single Agent in Subjects With Advanced Cancers
Lung NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Dose Limiting Toxicity
Up to 4 weeks
Number of subjects with Treatment-Emergent Adverse Events according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 (or most current version)
Screening through 4 weeks after study completion, an average of 6 months
Confirmed Objective Response Rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1)
Part 2 Only: Average of 6 months

Secondary Endpoints

Confirmed Best Overall Response (BOR) as per Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1)
Every 8 weeks for first 32 weeks, then 12 weeks through study completion, an average of 6 months
Duration of Response (DoR) as per Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1)
Every 8 weeks for first 32 weeks, then 12 weeks through study completion, an average of 6 months
Objective response rate and duration of response (DOR) based on Modified RECIST 1.1 for immune based therapeutics
Part 2 Only: Every 8 weeks for first 32 weeks, then 12 weeks through study completion, an average of 6 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CK-301 (cosibelimab)EXPERIMENTALPart 1 - Dose Escalation; Part 2 - Dose Expansion

Interventions

NameTypeDescription
CK-301 (cosibelimab)DRUGCK-301 will be administered in periods of 28-day cycles.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites48

Inclusion Criteria: * Signed written informed consent. * Male or female subjects aged greater than or equal to 18 years. * For NSCLC: Histologically or cytologically confirmed diagnosis of unresectable recurrent or metastatic non-small cell lung cancer. * For CRC: Histologically confirmed diagnosis...

Countries:AustraliaFranceNew ZealandPolandRussiaSouth AfricaSpainThailandUkraine
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Frequently asked questions about CK-301

What is CK-301 used for?

CK-301, also known as cosibelimab, is an investigational small molecule being studied for the treatment of advanced cancers, including lung neoplasms such as non-small-cell lung carcinoma and small cell carcinoma. It is also being evaluated in other solid tumors and hematologic malignancies, including head and neck cancer, melanoma, Merkel cell carcinoma, and classical Hodgkin lymphoma.

What does CK-301 target?

CK-301 targets PD-L1, a protein that helps cancer cells evade the immune system. By binding to PD-L1, CK-301 is designed to block the interaction between PD-L1 and its receptors, potentially restoring the immune system's ability to attack cancer cells. This mechanism is being investigated in a Phase 1 clinical trial.

Who makes CK-301?

CK-301 is being developed by Fortress Biotech, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol FBIO. The company is conducting clinical research on this investigational agent for the treatment of advanced cancers.

What phase is CK-301 in?

CK-301 is in Phase 1 clinical development. It is an investigational agent, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to evaluate its safety and efficacy in patients with advanced cancers.

What clinical trials is CK-301 in?

CK-301 is being studied in a Phase 1 clinical trial with the identifier NCT03212404. This trial is titled "Phase 1 Study of CK-301 (Cosibelimab) as a Single Agent in Subjects With Advanced Cancers" and is active but not recruiting participants. The trial has an enrollment of 272 participants and is being conducted in multiple countries.

Is CK-301 the same as cosibelimab?

Yes, CK-301 is also known as cosibelimab. Both names refer to the same investigational drug being developed by Fortress Biotech, Inc. for the treatment of advanced cancers, including lung neoplasms and other solid tumors.