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

  • STATUS
    Recruiting
  • End date
    Dec 22, 2022
  • participants needed
    500
  • sponsor
    Checkpoint Therapeutics, Inc.
Updated on 22 March 2021
metastatic melanoma
renal function
cancer
lymphoma
hodgkin's disease
monoclonal antibodies
measurable disease
carcinoma
squamous cell carcinoma
lung cancer
dental caries
cavity
metastasis
pd-l1
programmed cell death 1 ligand 1
cancer chemotherapy
squamous cell carcinoma of the head and neck
squamous cell carcinoma of head and neck
msi-h
metastatic cancer
renal function tests
transitional cell carcinoma
metastatic transitional cell carcinoma
stage iv nsclc
ck-301
stage iv non-small cell lung cancer
endometrial carcinoma
kidney function test
lung carcinoma
ocular melanoma
metastatic merkel cell carcinoma
merkel cell carcinoma

Summary

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.

Description

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.

Details
Condition Non-Small Cell Lung Cancer, Pulmonary Disease, Adenocarcinoma, Colorectal Cancer, Endometrial Carcinoma, Oat cell carcinoma, Malignant neoplasm of kidney, Neuroendocrine carcinoma, Uterine Cancer, Lymphoma, melanoma, Transitional cell carcinoma, Renal Cell Carcinoma, Lung Neoplasm, skin cancer, Lymphoma, Merkel cell carcinoma, head and neck cancer, Metastatic Melanoma, Non-Hodgkin's Lymphoma, Colon Cancer Screening, Colon cancer; rectal cancer, Classical Hodgkin Lymphoma, Cutaneous Squamous Cell Carcinoma, Skin Squamous Cell Carcinoma, Malignant Mesothelioma, Advanced, Malignant Mesothelioma, Advanced, Kidney Cancer, Lung Cancer, Endometrial Cancer, Malignant Melanoma, Malignant Adenoma, Lung Disease, Renal Cell Cancer, Renal Cancer, Malignant Mesothelioma, Advanced, Malignant Mesothelioma, Advanced, Malignant Mesothelioma, Advanced, Malignant Mesothelioma, Advanced, Urothelial Carcinoma, Malignant Mesothelioma, Advanced, Malignant Mesothelioma, Advanced, Malignant Mesothelioma, Advanced, Malignant Mesothelioma, Advanced, clear cell renal cell carcinoma, non-hodgkin's lymphoma (nhl), cancer of the head and neck, lung tumor, squamous cell skin cancer, Malignant Mesothelioma, Advanced, Malignant Mesothelioma, Advanced, Malignant Mesothelioma, Advanced, Malignant Mesothelioma, Advanced, Malignant Mesothelioma, Advanced
Treatment CK-301, CK-301 (cosibelimab)
Clinical Study IdentifierNCT03212404
SponsorCheckpoint Therapeutics, Inc.
Last Modified on22 March 2021

Eligibility

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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note