Brief Summary
CK-301 (cosibelimab) is a fully human monoclonal antibodya protein made by the immune system to fight against harmful substances (antigens), such as bacteria or viruses 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.
Intervention / Treatment
- Drug: CK-301 (cosibelimab)
Inclusion Criteria
- Signed written informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment..
- Male or female subjects aged greater than or equal to 18 years.
- For NSCLC: Histologically or cytologically confirmed diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results of unresectable recurrent or metastatic non-small cell lung cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs.
- For CRC: Histologically confirmed diagnosis of recurrent or metastatic colorectalrelating to the colon or rectum in the large bowel/intestine cancer assessed as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).
- For EC: Histologically or cytologically confirmed advancedat a late stage, far along, recurrent or metastatic endometrial carcinomacancer arising from tissues that line organs.
- 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 malignantcancerous, may grow and spread to other areas of the body 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 (surgerytreatment involving removal of cancerous tissue and/or tumours and a margin of healthy tissue around it to reduce recurrence or radiation therapya treatment that uses controlled doses of radiation to damage or kill cancer cells with or without chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells).
- For MEL: Histologically confirmed diagnosis of unresectable Stage III or metastatic melanomaa type of cancer that develops from melanocytes, which are the cells that produce pigment generally in the skin (but can develop in other areas of the body) 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 cureno evidence of disease; complete cancer remission 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 bladdera hollow, muscular sac in the pelvis that stores urine, urethrathe tube that carries urine from the bladder to outside of the body) not amenable to cure by surgery or other means.
- For HL: Histologically confirmed primary diagnosis of classical Hodgkin’s lymphomacancers of the lymphatic system.
- For B-cell NHL: Histologically confirmed diagnosis of non-Hodgkin lymphoma.
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer 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 tissuea group of cells that work together to perform a function sample from a biopsyremoval of a section of tissue to analyse for cancer cells 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 riskthe possibility that something bad will happen of conception exists.
- Other protocol defined inclusion criteria could apply.