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

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ClinicalTrials.gov Identifier: NCT03212404
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : July 23, 2019
Sponsor:
Collaborator:
Novotech (Australia) Pty Limited
Information provided by (Responsible Party):
Checkpoint Therapeutics, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
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 Colorectal Cancer Cutaneous Squamous Cell Carcinoma Non Hodgkin Lymphoma Endometrial Cancer Drug: CK-301 (cosibelimab) Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-label, Multicenter, Dose-escalation Study of CK-301 Administered Intravenously as a Single Agent to Subjects With Advanced Cancers
Actual Study Start Date : September 20, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Experimental: CK-301 (cosibelimab)
Part 1 - Dose Escalation; Part 2 - Dose Expansion
Drug: CK-301 (cosibelimab)
CK-301 will be administered in periods of 28-day cycles.




Primary Outcome Measures :
  1. Dose Limiting Toxicity [ Time Frame: Up to 4 weeks ]
  2. 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) [ Time Frame: Screening through 4 weeks after study completion, an average of 6 months ]
  3. Confirmed Objective Response Rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) [ Time Frame: Part 2 Only: Average of 6 months ]

Secondary Outcome Measures :
  1. Confirmed Best Overall Response (BOR) as per Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) [ Time Frame: Every 8 weeks for first 32 weeks, then 12 weeks through study completion, an average of 6 months ]
  2. Duration of Response (DoR) as per Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) [ Time Frame: Every 8 weeks for first 32 weeks, then 12 weeks through study completion, an average of 6 months ]
  3. Objective response rate and duration of response (DOR) based on Modified RECIST 1.1 for immune based therapeutics [ Time Frame: Part 2 Only: Every 8 weeks for first 32 weeks, then 12 weeks through study completion, an average of 6 months ]
  4. Overall Survival (OS) [ Time Frame: Part 2 Only: Every 8 weeks for first 32 weeks, then 12 weeks through study completion, an average of 6 months ]
  5. Pharmacokinetic parameter: AUC (0-t) of CK-301 [ Time Frame: Baseline up to 12 weeks after study completion, an average of 6 months ]
  6. Pharmacokinetic parameter: AUC (0-infinity) of CK-301 [ Time Frame: Baseline up to 12 weeks after study completion, an average of 6 months ]
  7. Pharmacokinetic parameter: Cmax of CK-301 [ Time Frame: Baseline up to 12 weeks after study completion, an average of 6 months ]
  8. Pharmacokinetic parameter: Tmax of CK-301 [ Time Frame: Baseline up to 12 weeks after study completion, an average of 6 months ]
  9. Pharmacokinetic parameter: T(1/2) of CK-301 [ Time Frame: Baseline up to 12 weeks after study completion, an average of 6 months ]
  10. Number of subjects with anti-CK-301 antibodies [ Time Frame: Baseline up to 12 weeks after study completion, an average of 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03212404


Contacts
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Contact: James Oliviero 001-212-574-2830 info@checkpointtx.com

Locations
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Australia, New South Wales
Research Site Recruiting
Wollongong, New South Wales, Australia, 2500
Australia, Victoria
Research Site Recruiting
Box Hill, Victoria, Australia, 3128
Research Site Recruiting
Malvern, Victoria, Australia, 3144
New Zealand
Research Site Recruiting
Christchurch, New Zealand, 8140
Poland
Research Site Recruiting
Kraków, Poland, 31-826
Research Site Recruiting
Lublin, Poland, 20064
Research Site Recruiting
Poznań, Poland, 60693
Research Site Recruiting
Warsaw, Poland, 02-781
Research Site Recruiting
Łódź, Poland, 90302
Russian Federation
Research Site Recruiting
Chelyabinsk, Russian Federation, 454087
Research Site Recruiting
Kazan, Russian Federation, 420029
Research Site Recruiting
Murmansk, Russian Federation, 183047
Research Site Recruiting
Novosibirsk, Russian Federation, 630108
Research Site Recruiting
Omsk, Russian Federation, 644013
Research Site Recruiting
Saint Petersburg, Russian Federation, 197022
Research Site Recruiting
Saint Petersburg, Russian Federation, 197758
Research Site Recruiting
Tyumen, Russian Federation, 625041
Research Site Recruiting
Volgograd, Russian Federation, 400138
Thailand
Research Site Recruiting
Hat Yai, Songkhla, Thailand, 90110
Research Site Recruiting
Bangkok, Thailand, 10210
Research Site Recruiting
Bangkok, Thailand, 10330
Research Site Recruiting
Chiang Mai, Thailand, 50200
Research Site Recruiting
Khon Kaen, Thailand, 40002
Sponsors and Collaborators
Checkpoint Therapeutics, Inc.
Novotech (Australia) Pty Limited

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Responsible Party: Checkpoint Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03212404     History of Changes
Other Study ID Numbers: CK-301-101
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Checkpoint Therapeutics, Inc.:
Cancer
PD-L1
PDL1
PD-1
PD1
Solid tumors
Anti PD-L1
MSI-High
Endometrial
Non-small cell lung cancer, NSCLC
CK-301
Additional relevant MeSH terms:
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Carcinoma, Merkel Cell
Lymphoma
Carcinoma
Carcinoma, Renal Cell
Endometrial Neoplasms
Mesothelioma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Small Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Glandular and Epithelial
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neoplasms by Site
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Uterine Diseases