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Trial record 1 of 1 for:    NCT03212404
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Phase 1 Study of CK-301 as a Single Agent in Subjects With Advanced Cancers

This study is currently recruiting participants.
Verified November 2017 by Checkpoint Therapeutics, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03212404
First Posted: July 11, 2017
Last Update Posted: November 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Novotech (Australia) Pty Limited
Information provided by (Responsible Party):
Checkpoint Therapeutics, Inc.
  Purpose
CK-301 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 objective of this study is to assess the safety, tolerability and preliminary efficacy of CK-301 when administered intravenously as a single agent to subjects with selected recurrent or metastatic cancers.

Condition Intervention 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 Drug: CK-301 Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Checkpoint Therapeutics, Inc.:

Primary Outcome Measures:
  • Dose Limiting Toxicity [ Time Frame: 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) [ Time Frame: Screening through 4 weeks after study completion, an average of 6 months ]

Secondary Outcome Measures:
  • 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 ]
  • Confirmed Objective Response Rate (ORR) 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 ]
  • 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 ]
  • Pharmacokinetic parameter: AUC (0-t) of CK-301 [ Time Frame: Baseline up to 12 weeks after study completion, an average of 6 months ]
  • Pharmacokinetic parameter: AUC (0-infinity) of CK-301 [ Time Frame: Baseline up to 12 weeks after study completion, an average of 6 months ]
  • Pharmacokinetic parameter: Cmax of CK-301 [ Time Frame: Baseline up to 12 weeks after study completion, an average of 6 months ]
  • Pharmacokinetic parameter: Tmax of CK-301 [ Time Frame: Baseline up to 12 weeks after study completion, an average of 6 months ]
  • Pharmacokinetic parameter: T(1/2) of CK-301 [ Time Frame: Baseline up to 12 weeks after study completion, an average of 6 months ]
  • Number of subjects with anti-CK-301 antibodies [ Time Frame: Baseline up to 12 weeks after study completion, an average of 6 months ]

Estimated Enrollment: 80
Actual Study Start Date: September 20, 2017
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CK-301 Drug: CK-301
CK-301 will be administered in periods of 28-day cycles.

Detailed Description:
This is a first-in-human, Phase 1, open-label, multicenter, dose-escalation study of CK-301, 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). 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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 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.
  • 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.
  Contacts and Locations
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
Contact: James Oliviero 001-212-574-2830 info@checkpointtx.com

Locations
Australia, New South Wales
Research Site Recruiting
Wollongong, New South Wales, Australia, 2500
Australia, Victoria
Research Site Recruiting
Malvern, Victoria, Australia, 3144
Sponsors and Collaborators
Checkpoint Therapeutics, Inc.
Novotech (Australia) Pty Limited
  More Information

Responsible Party: Checkpoint Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03212404     History of Changes
Other Study ID Numbers: CK-301-101
First Submitted: July 6, 2017
First Posted: July 11, 2017
Last Update Posted: November 8, 2017
Last Verified: November 2017

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

Additional relevant MeSH terms:
Carcinoma
Hodgkin Disease
Head and Neck Neoplasms
Carcinoma, Renal Cell
Mesothelioma
Carcinoma, Non-Small-Cell Lung
Carcinoma, Transitional Cell
Lung Neoplasms
Carcinoma, Merkel Cell
Carcinoma, Small Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Lymphoma
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Site
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases
Adenoma
Neoplasms, Mesothelial
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms