Clinical Trials /

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

NCT03212404

Description:

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.

Related Conditions:
  • B-Cell Non-Hodgkin Lymphoma
  • Classical Hodgkin Lymphoma
  • Colorectal Carcinoma
  • Endometrial Carcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Melanoma
  • Merkel Cell Carcinoma
  • Non-Small Cell Lung Carcinoma
  • Peritoneal Mesothelioma
  • Pleural Mesothelioma
  • Renal Cell Carcinoma
  • Skin Squamous Cell Carcinoma
  • Small Cell Lung Carcinoma
  • Urothelial Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Phase 1 Study of CK-301 as a Single Agent in Subjects With Advanced Cancers
  • 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

Clinical Trial IDs

  • ORG STUDY ID: CK-301-101
  • NCT ID: NCT03212404

Conditions

  • 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

Interventions

DrugSynonymsArms
CK-301CK-301

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 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.

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 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.
    

Trial Arms

NameTypeDescriptionInterventions
CK-301ExperimentalPart 1 - Dose Escalation; Part 2 - Dose Expansion
  • CK-301

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose Limiting Toxicity
Time Frame:Up to 4 weeks
Safety Issue:
Description:

Secondary Outcome Measures

Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure:Pharmacokinetic parameter: AUC (0-t) of CK-301
Time Frame:Baseline up to 12 weeks after study completion, an average of 6 months
Safety Issue:
Description:
Measure:Pharmacokinetic parameter: AUC (0-infinity) of CK-301
Time Frame:Baseline up to 12 weeks after study completion, an average of 6 months
Safety Issue:
Description:
Measure:Pharmacokinetic parameter: Cmax of CK-301
Time Frame:Baseline up to 12 weeks after study completion, an average of 6 months
Safety Issue:
Description:
Measure:Pharmacokinetic parameter: Tmax of CK-301
Time Frame:Baseline up to 12 weeks after study completion, an average of 6 months
Safety Issue:
Description:
Measure:Pharmacokinetic parameter: T(1/2) of CK-301
Time Frame:Baseline up to 12 weeks after study completion, an average of 6 months
Safety Issue:
Description:
Measure:Number of subjects with anti-CK-301 antibodies
Time Frame:Baseline up to 12 weeks after study completion, an average of 6 months
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Checkpoint Therapeutics, Inc.

Trial Keywords

  • Cancer
  • PD-L1
  • PDL1
  • PD-1
  • PD1
  • Solid tumors
  • Anti PD-L1
  • MSI-High
  • Endometrial
  • Non-small cell lung cancer, NSCLC
  • CK-301

Last Updated