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

NCT03212404 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: CK-301-101
• Study Type: interventional
• Target: 272
• Locations: 9 countries
• Sites: 48

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.

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

Keywords

Cancer; PD-L1; PDL1; PD-1; PD1; Solid tumors; Anti PD-L1; Non-small cell lung cancer, NSCLC; CK-301; CSCC; Skin cancer

Outcome Measures

Primary Outcomes (3)

• Dose Limiting Toxicity

  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)

  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)

  Part 2 Only: Average of 6 months

Secondary Outcomes (10)

• 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

• 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

• 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

• 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

Study Arms (1)

CK-301 (cosibelimab)

EXPERIMENTAL

Part 1 - Dose Escalation; Part 2 - Dose Expansion

Drug: CK-301 (cosibelimab)

Interventions

CK-301 (cosibelimab) DRUG

CK-301 will be administered in periods of 28-day cycles.

CK-301 (cosibelimab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Checkpoint Therapeutics, Inc.: lead
• Novotech (Australia) Pty Limited: collaborator

Study Sites (48)

Research Site

Wollongong, New South Wales, 2500, Australia

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Benowa, Queensland, 4217, Australia

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Buderim, Queensland, 4556, Australia

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Greenslopes, Queensland, 4120, Australia

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South Brisbane, Queensland, 4101, Australia

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Woolloongabba, Queensland, 4102, Australia

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Box Hill, Victoria, 3128, Australia

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Malvern, Victoria, 3144, Australia

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Besançon, 25030, France

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Bordeaux, 33075, France

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Grenoble, 38700, France

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Lyon, 69495, France

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Nice, France

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Christchurch, 8140, New Zealand

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Krakow, 31-826, Poland

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Lodz, 90302, Poland

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Lublin, 20064, Poland

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Poznan, 60693, Poland

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Warsaw, 02-781, Poland

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Chelyabinsk, 454087, Russia

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Kazan', 420029, Russia

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Murmansk, 183047, Russia

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Novosibirsk, 630108, Russia

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Omsk, 644013, Russia

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Saint Petersburg, 197022, Russia

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Saint Petersburg, 197758, Russia

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Tyumen, 625041, Russia

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Volgograd, 400138, Russia

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Cape Town, 7700, South Africa

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George, 6529, South Africa

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Port Elizabeth, South Africa

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Pretoria, 0081, South Africa

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Soweto, 2013, South Africa

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Barcelona, Spain

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Madrid, Spain

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Málaga, Spain

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Pamplona, 31008, Spain

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San Cristóbal de La Laguna, 38320, Spain

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Seville, Spain

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Valencia, Spain

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Hat Yai, Changwat Songkhla, 90110, Thailand

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Bangkok, 10210, Thailand

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Bangkok, 10330, Thailand

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Chiang Mai, 50200, Thailand

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Khon Kaen, 40002, Thailand

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Chernivtsi, 58013, Ukraine

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Kharkiv, 61103, Ukraine

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Sumy, 40022, Ukraine

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Related Publications (1)

• Clingan P, Ladwa R, Brungs D, Harris DL, McGrath M, Arnold S, Coward J, Fourie S, Kurochkin A, Malan DR, Mant A, Sharma V, Shue H, Tazbirkova A, Berciano-Guerrero MA, Charoentum C, Dalle S, Dechaphunkul A, Dudnichenko O, Koralewski P, Lugowska I, Montaudie H, Munoz-Couselo E, Sriuranpong V, Oliviero J, Desai J. Efficacy and safety of cosibelimab, an anti-PD-L1 antibody, in metastatic cutaneous squamous cell carcinoma. J Immunother Cancer. 2023 Oct;11(10):e007637. doi: 10.1136/jitc-2023-007637.

  PMID: 37848259 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Small Cell; Mesothelioma, Malignant; Head and Neck Neoplasms; Melanoma; Carcinoma, Merkel Cell; Carcinoma, Renal Cell; Carcinoma, Transitional Cell; Lymphoma, Non-Hodgkin; Endometrial Neoplasms; Neoplasms; Skin Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Mesothelioma; Adenoma; Neoplasms, Mesothelial; Pleural Neoplasms; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Diseases; Skin and Connective Tissue Diseases; Polyomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Carcinoma, Neuroendocrine; Adenocarcinoma; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Genital Diseases, Female; Genital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2017
• First Posted: July 11, 2017
• Study Start: September 20, 2017
• Primary Completion: November 18, 2021
• Study Completion: December 1, 2025
• Last Updated: February 3, 2025

Record last verified: 2025-01

Locations

AU (8); ES (7); FR (5); TH (5); NZ (1); UA (3); ZA (5); PL (5); RU (9)