Lung NeoplasmsCarcinoma, Non-Small-Cell LungCarcinoma, Small CellMalignant Mesothelioma, AdvancedHead and Neck CancerMelanomaMerkel Cell CarcinomaRenal Cell CarcinomaUrothelial CarcinomaClassical Hodgkin LymphomaCutaneous Squamous Cell CarcinomaNon Hodgkin LymphomaEndometrial Cancer
Investigational drug(s) / intervention(s)
CK-301 (cosibelimab)
CK-301 (cosibelimab): CK-301 will be administered in periods of 28-day cycles.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
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
Trial sites (48)
Facility
City
Region
Status
Research Site
Wollongong
New South Wales
Research Site
Benowa
Queensland
Research Site
Buderim
Queensland
Research Site
Greenslopes
Queensland
Research Site
South Brisbane
Queensland
Research Site
Woolloongabba
Queensland
Research Site
Box Hill
Victoria
Research Site
Malvern
Victoria
Research Site
Besançon
France
Research Site
Bordeaux
France
Research Site
Grenoble
France
Research Site
Lyon
France
Research Site
Nice
France
Research Site
Christchurch
New Zealand
Research Site
Krakow
Poland
Research Site
Lodz
Poland
Research Site
Lublin
Poland
Research Site
Poznan
Poland
Research Site
Warsaw
Poland
Research Site
Chelyabinsk
Russia
Research Site
Kazan'
Russia
Research Site
Murmansk
Russia
Research Site
Novosibirsk
Russia
Research Site
Omsk
Russia
Research Site
Saint Petersburg
Russia
Research Site
Saint Petersburg
Russia
Research Site
Tyumen
Russia
Research Site
Volgograd
Russia
Research Site
Cape Town
South Africa
Research Site
George
South Africa
Research Site
Port Elizabeth
South Africa
Research Site
Pretoria
South Africa
Research Site
Soweto
South Africa
Research Site
Barcelona
Spain
Research Site
Madrid
Spain
Research Site
Málaga
Spain
Research Site
Pamplona
Spain
Research Site
San Cristóbal de La Laguna
Spain
Research Site
Seville
Spain
Research Site
Valencia
Spain
+ 8 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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