NCT03212404
Active, not recruiting
Phase 1
A Phase 1, Open-label, Multicenter, Dose-escalation Study of CK-301 Administered Intravenously as a Single Agent to Subjects With Advanced Cancers
Checkpoint Therapeutics, Inc.1 site in 1 country272 target enrollmentStarted: September 20, 2017Last updated:
ConditionsLung 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
InterventionsCK-301 (cosibelimab)
DrugsCK-301 (cosibelimab)
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 272
- Locations
- 1
- Primary Endpoint
- Dose Limiting Toxicity
Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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).
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.
Arms & Interventions
CK-301 (cosibelimab)
Experimental
Part 1 - Dose Escalation; Part 2 - Dose Expansion
Intervention: CK-301 (cosibelimab) (Drug)
Outcomes
Primary Outcomes
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
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 Outcomes
- Duration of Response (DoR) as per Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1)(Every 8 weeks for first 32 weeks, then 12 weeks through study completion, an average of 6 months)
- Overall Survival (OS)(Part 2 Only: 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(Baseline up to 12 weeks after study completion, an average of 6 months)
- Pharmacokinetic parameter: AUC (0-infinity) of CK-301(Baseline up to 12 weeks after study completion, an average of 6 months)
- Pharmacokinetic parameter: Cmax of CK-301(Baseline up to 12 weeks after study completion, an average of 6 months)
- Number of subjects with anti-CK-301 antibodies(Baseline up to 12 weeks after study completion, an average of 6 months)
- Objective response rate and duration of response (DOR) based on Modified RECIST 1.1 for immune based therapeutics(Part 2 Only: Every 8 weeks for first 32 weeks, then 12 weeks through study completion, an average of 6 months)
- Confirmed Best Overall Response (BOR) as per Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1)(Every 8 weeks for first 32 weeks, then 12 weeks through study completion, an average of 6 months)
- Pharmacokinetic parameter: Tmax of CK-301(Baseline up to 12 weeks after study completion, an average of 6 months)
- Pharmacokinetic parameter: T(1/2) of CK-301(Baseline up to 12 weeks after study completion, an average of 6 months)
Investigators
Study Sites (1)
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