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

January 31, 2025 updated by: Checkpoint Therapeutics, Inc.

A Phase 1, Open-label, Multicenter, Dose-escalation Study of CK-301 Administered Intravenously as a Single Agent to Subjects With Advanced Cancers

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

272

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Wollongong, New South Wales, Australia, 2500
        • Research Site
    • Queensland
      • Benowa, Queensland, Australia, 4217
        • Research Site
      • Buderim, Queensland, Australia, 4556
        • Research Site
      • Greenslopes, Queensland, Australia, 4120
        • Research Site
      • South Brisbane, Queensland, Australia, 4101
        • Research Site
      • Woolloongabba, Queensland, Australia, 4102
        • Research Site
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Research Site
      • Malvern, Victoria, Australia, 3144
        • Research Site
  • France
      • Besançon, France, 25030
        • Research Site
      • Bordeaux, France, 33075
        • Research Site
      • Grenoble, France, 38700
        • Research Site
      • Lyon, France, 69495
        • Research Site
      • Nice, France
        • Research Site
  • New Zealand
      • Christchurch, New Zealand, 8140
        • Research Site
  • Poland
      • Kraków, Poland, 31-826
        • Research Site
      • Lublin, Poland, 20064
        • Research Site
      • Poznań, Poland, 60693
        • Research Site
      • Warsaw, Poland, 02-781
        • Research Site
      • Łódź, Poland, 90302
        • Research Site
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454087
        • Research Site
      • Kazan, Russian Federation, 420029
        • Research Site
      • Murmansk, Russian Federation, 183047
        • Research Site
      • Novosibirsk, Russian Federation, 630108
        • Research Site
      • Omsk, Russian Federation, 644013
        • Research Site
      • Saint Petersburg, Russian Federation, 197022
        • Research Site
      • Saint Petersburg, Russian Federation, 197758
        • Research Site
      • Tyumen, Russian Federation, 625041
        • Research Site
      • Volgograd, Russian Federation, 400138
        • Research Site
  • South Africa
      • Cape Town, South Africa, 7700
        • Research Site
      • George, South Africa, 6529
        • Research Site
      • Port Elizabeth, South Africa
        • Research Site
      • Pretoria, South Africa, 0081
        • Research Site
      • Soweto, South Africa, 2013
        • Research Site
  • Spain
      • Barcelona, Spain
        • Research Site
      • La Laguna, Spain, 38320
        • Research Site
      • Madrid, Spain
        • Research Site
      • Málaga, Spain
        • Research Site
      • Pamplona, Spain, 31008
        • Research Site
      • Sevilla, Spain
        • Research Site
      • Valencia, Spain
        • Research Site
  • Thailand
      • Bangkok, Thailand, 10210
        • Research Site
      • Bangkok, Thailand, 10330
        • Research Site
      • Chiang Mai, Thailand, 50200
        • Research Site
      • Khon Kaen, Thailand, 40002
        • Research Site
    • Songkhla
      • Hat Yai, Songkhla, Thailand, 90110
        • Research Site
  • Ukraine
      • Chernivtsi, Ukraine, 58013
        • Research Site
      • Kharkiv, Ukraine, 61103
        • Research Site
      • Sumy, Ukraine, 40022
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dose Limiting Toxicity
Time Frame: Up to 4 weeks
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
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
Part 2 Only: Average of 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
Every 8 weeks for first 32 weeks, then 12 weeks through 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
Time Frame: Part 2 Only: Every 8 weeks for first 32 weeks, then 12 weeks through study completion, an average of 6 months
Part 2 Only: Every 8 weeks for first 32 weeks, then 12 weeks through study completion, an average of 6 months
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
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
Time Frame: Baseline up to 12 weeks after study completion, an average of 6 months
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
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
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
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
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
Baseline up to 12 weeks after study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Checkpoint Therapeutics, Inc.

Collaborators

Novotech (Australia) Pty Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2017

Primary Completion (Actual)

November 18, 2021

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

July 6, 2017

First Submitted That Met QC Criteria

July 6, 2017

First Posted (Actual)

July 11, 2017

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 31, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CK-301-101

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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