Phase 1 Study of CK-301 (Cosibelimab) as a Single Agent in Subjects With Advanced Cancers

  • End date
    Dec 10, 2023
  • participants needed
  • sponsor
    Checkpoint Therapeutics, Inc.
Updated on 10 March 2022
metastatic melanoma
renal function
hodgkin's disease
monoclonal antibodies
measurable disease
squamous cell carcinoma
lung cancer
dental caries
programmed cell death 1 ligand 1
cancer chemotherapy
squamous cell carcinoma of the head and neck
squamous cell carcinoma of head and neck
metastatic cancer
renal function tests
transitional cell carcinoma
metastatic transitional cell carcinoma
stage iv nsclc
stage iv non-small cell lung cancer
endometrial carcinoma
kidney function test
lung carcinoma
ocular melanoma
metastatic merkel cell carcinoma
merkel cell carcinoma


CK-301 (cosibelimab) is a fully human monoclonal antibody of IgG1 subtype that directly binds to Programmed Death-Ligand 1 (PD-L1) and blocks its interactions with the Programmed Death-1 (PD-1) and B7.1 receptors. The primary objectives of this study are to assess the safety, tolerability and efficacy of CK-301 when administered intravenously as a single agent to subjects with selected recurrent or metastatic cancers.


This is a first-in-human, Phase 1, open-label, multicenter, dose-escalation study of CK-301 (cosibelimab), a fully human monoclonal IgG1 antibody targeting PD-L1. The study will consist of 3 periods: Screening (up to 28 days), Treatment (28-day cycles), and Follow-up (up to 6 months of visits with survival follow-up for select cohorts). Following the dose escalation portion of the study, additional evaluable subjects may be included in order to further characterize safety and efficacy at selected doses and/or in specific patient sub-groups.

Condition Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Small Cell, Malignant Mesothelioma, Advanced, Head and Neck Cancer, Melanoma, Merkel Cell Carcinoma, Renal Cell Carcinoma, Urothelial Carcinoma, Classical Hodgkin Lymphoma, Cutaneous Squamous Cell Carcinoma, Non Hodgkin Lymphoma, Endometrial Cancer
Treatment CK-301, CK-301 (cosibelimab)
Clinical Study IdentifierNCT03212404
SponsorCheckpoint Therapeutics, Inc.
Last Modified on10 March 2022


Yes No Not Sure

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 of recurrent or metastatic colorectal cancer assessed as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)
For EC: Histologically or cytologically confirmed advanced, recurrent or metastatic endometrial carcinoma
For cSCC: Histologically confirmed diagnosis of unresectable or metastatic cutaneous squamous cell carcinoma not amenable to local therapy
For SCLC: Histologically or cytologically confirmed diagnosis of unresectable small cell lung cancer
For MPM: Histologically or cytologically confirmed diagnosis of unresectable malignant pleural or peritoneal mesothelioma
For HNSCC: Histologically or cytologically confirmed diagnosis of recurrent or metastatic HNSCC (oral cavity, pharynx, larynx), stage III/IV and not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy)
For MEL: Histologically confirmed diagnosis of unresectable Stage III or metastatic melanoma not amenable to local therapy (excluding uveal or ocular melanoma)
For MCC: Histologically confirmed diagnosis of metastatic Merkel cell carcinoma not amenable to local therapy
For RCC: Histologically confirmed diagnosis of renal cell carcinoma (with clear cell component) with advanced or metastatic disease that is not amenable to cure by surgery or other means
For UC: Histologically or cytologically documented locally advanced or metastatic transitional cell carcinoma of the urothelium (including renal pelvis, ureters, urinary bladder, urethra) not amenable to cure by surgery or other means
For HL: Histologically confirmed primary diagnosis of classical Hodgkin's lymphoma
For B-cell NHL: Histologically confirmed diagnosis of non-Hodgkin lymphoma
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry and an estimated life expectancy of at least 3 months
Must have at least one measurable lesion based on RECIST 1.1
Have provided a formalin fixed tumor tissue sample from a biopsy of a tumor lesion either at the time of or after the diagnosis of metastatic disease has been made AND from a site not previously irradiated
Adequate hematological, hepatic and renal function as defined in the protocol
Effective contraception for both male and female subjects if the risk of conception exists
Other protocol defined inclusion criteria could apply

Exclusion Criteria

Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
Concurrent treatment with a non-permitted drug
History of severe hypersensitivity reactions to other monoclonal antibodies
Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast, or localized prostate cancer
Chemotherapy, radioactive, biological cancer therapy, or tyrosine kinase inhibitor (TKI) therapy, within four weeks prior to the first dose of study drug, or who has not recovered to NCI CTCAE Grade 1 or better from the AEs due to cancer therapeutics administered more than four weeks earlier
Significant acute or chronic infections as defined in the protocol
Active or history of interstitial lung disease (ILD), or has had a history of pneumonitis that has required oral or IV steroids
Active or suspected autoimmune disease or a documented history of autoimmune disease
Known current drug or alcohol abuse
Underlying medical conditions that will make the administration of study drug hazardous or obscure the interpretation of toxicity determination or adverse events
Use of other investigational therapy within 28 days before study drug administration
Pregnant or breastfeeding
Uncontrolled or significant cardiovascular disease
Psychiatric illness or social situation that would preclude study compliance
Receipt of live, attenuated vaccine within 28 days prior to the first dose of study drug
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