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.
Title
- Brief Title: Phase 1 Study of CK-301 (Cosibelimab) 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
- Cutaneous Squamous Cell Carcinoma
- Non Hodgkin Lymphoma
- Endometrial Cancer
Interventions
Drug | Synonyms | Arms |
---|
CK-301 (cosibelimab) | | CK-301 (cosibelimab) |
Purpose
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.
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.
Trial Arms
Name | Type | Description | Interventions |
---|
CK-301 (cosibelimab) | Experimental | Part 1 - Dose Escalation; Part 2 - Dose Expansion | |
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
- Non-small cell lung cancer, NSCLC
- CK-301
- CSCC
- Skin cancer
Last Updated
March 16, 2021