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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03212404




Registration number
NCT03212404
Ethics application status
Date submitted
6/07/2017
Date registered
11/07/2017
Date last updated
29/08/2023

Titles & IDs
Public title
Phase 1 Study of CK-301 (Cosibelimab) as a Single Agent in Subjects With Advanced Cancers
Scientific title
A Phase 1, Open-label, Multicenter, Dose-escalation Study of CK-301 Administered Intravenously as a Single Agent to Subjects With Advanced Cancers
Secondary ID [1] 0 0
CK-301-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Neoplasms 0 0
Carcinoma, Non-Small-Cell Lung 0 0
Carcinoma, Small Cell 0 0
Malignant Mesothelioma, Advanced 0 0
Head and Neck Cancer 0 0
Melanoma 0 0
Merkel Cell Carcinoma 0 0
Renal Cell Carcinoma 0 0
Urothelial Carcinoma 0 0
Classical Hodgkin Lymphoma 0 0
Cutaneous Squamous Cell Carcinoma 0 0
Non Hodgkin Lymphoma 0 0
Endometrial Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CK-301 (cosibelimab)

Experimental: CK-301 (cosibelimab) - Part 1 - Dose Escalation; Part 2 - Dose Expansion


Treatment: Drugs: CK-301 (cosibelimab)
CK-301 will be administered in periods of 28-day cycles.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose Limiting Toxicity
Timepoint [1] 0 0
Up to 4 weeks
Primary outcome [2] 0 0
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)
Timepoint [2] 0 0
Screening through 4 weeks after study completion, an average of 6 months
Primary outcome [3] 0 0
Confirmed Objective Response Rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1)
Timepoint [3] 0 0
Part 2 Only: Average of 6 months
Secondary outcome [1] 0 0
Confirmed Best Overall Response (BOR) as per Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1)
Timepoint [1] 0 0
Every 8 weeks for first 32 weeks, then 12 weeks through study completion, an average of 6 months
Secondary outcome [2] 0 0
Duration of Response (DoR) as per Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1)
Timepoint [2] 0 0
Every 8 weeks for first 32 weeks, then 12 weeks through study completion, an average of 6 months
Secondary outcome [3] 0 0
Objective response rate and duration of response (DOR) based on Modified RECIST 1.1 for immune based therapeutics
Timepoint [3] 0 0
Part 2 Only: Every 8 weeks for first 32 weeks, then 12 weeks through study completion, an average of 6 months
Secondary outcome [4] 0 0
Overall Survival (OS)
Timepoint [4] 0 0
Part 2 Only: Every 8 weeks for first 32 weeks, then 12 weeks through study completion, an average of 6 months
Secondary outcome [5] 0 0
Pharmacokinetic parameter: AUC (0-t) of CK-301
Timepoint [5] 0 0
Baseline up to 12 weeks after study completion, an average of 6 months
Secondary outcome [6] 0 0
Pharmacokinetic parameter: AUC (0-infinity) of CK-301
Timepoint [6] 0 0
Baseline up to 12 weeks after study completion, an average of 6 months
Secondary outcome [7] 0 0
Pharmacokinetic parameter: Cmax of CK-301
Timepoint [7] 0 0
Baseline up to 12 weeks after study completion, an average of 6 months
Secondary outcome [8] 0 0
Pharmacokinetic parameter: Tmax of CK-301
Timepoint [8] 0 0
Baseline up to 12 weeks after study completion, an average of 6 months
Secondary outcome [9] 0 0
Pharmacokinetic parameter: T(1/2) of CK-301
Timepoint [9] 0 0
Baseline up to 12 weeks after study completion, an average of 6 months
Secondary outcome [10] 0 0
Number of subjects with anti-CK-301 antibodies
Timepoint [10] 0 0
Baseline up to 12 weeks after study completion, an average of 6 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/09/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Research Site - Wollongong
Recruitment hospital [2] 0 0
Research Site - Benowa
Recruitment hospital [3] 0 0
Research Site - Buderim
Recruitment hospital [4] 0 0
Research Site - Greenslopes
Recruitment hospital [5] 0 0
Research Site - South Brisbane
Recruitment hospital [6] 0 0
Research Site - Woolloongabba
Recruitment hospital [7] 0 0
Research Site - Box Hill
Recruitment hospital [8] 0 0
Research Site - Malvern
Recruitment postcode(s) [1] 0 0
2500 - Wollongong
Recruitment postcode(s) [2] 0 0
4217 - Benowa
Recruitment postcode(s) [3] 0 0
4556 - Buderim
Recruitment postcode(s) [4] 0 0
4120 - Greenslopes
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment postcode(s) [6] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [7] 0 0
3128 - Box Hill
Recruitment postcode(s) [8] 0 0
3144 - Malvern
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Besançon
Country [2] 0 0
France
State/province [2] 0 0
Bordeaux
Country [3] 0 0
France
State/province [3] 0 0
Grenoble
Country [4] 0 0
France
State/province [4] 0 0
Lyon
Country [5] 0 0
France
State/province [5] 0 0
Nice
Country [6] 0 0
New Zealand
State/province [6] 0 0
Christchurch
Country [7] 0 0
Poland
State/province [7] 0 0
Kraków
Country [8] 0 0
Poland
State/province [8] 0 0
Lublin
Country [9] 0 0
Poland
State/province [9] 0 0
Poznan
Country [10] 0 0
Poland
State/province [10] 0 0
Warsaw
Country [11] 0 0
Poland
State/province [11] 0 0
Lódz
Country [12] 0 0
Russian Federation
State/province [12] 0 0
Chelyabinsk
Country [13] 0 0
Russian Federation
State/province [13] 0 0
Kazan
Country [14] 0 0
Russian Federation
State/province [14] 0 0
Murmansk
Country [15] 0 0
Russian Federation
State/province [15] 0 0
Novosibirsk
Country [16] 0 0
Russian Federation
State/province [16] 0 0
Omsk
Country [17] 0 0
Russian Federation
State/province [17] 0 0
Saint Petersburg
Country [18] 0 0
Russian Federation
State/province [18] 0 0
Tyumen
Country [19] 0 0
Russian Federation
State/province [19] 0 0
Volgograd
Country [20] 0 0
South Africa
State/province [20] 0 0
Cape Town
Country [21] 0 0
South Africa
State/province [21] 0 0
George
Country [22] 0 0
South Africa
State/province [22] 0 0
Port Elizabeth
Country [23] 0 0
South Africa
State/province [23] 0 0
Pretoria
Country [24] 0 0
South Africa
State/province [24] 0 0
Soweto
Country [25] 0 0
Spain
State/province [25] 0 0
Barcelona
Country [26] 0 0
Spain
State/province [26] 0 0
La Laguna
Country [27] 0 0
Spain
State/province [27] 0 0
Madrid
Country [28] 0 0
Spain
State/province [28] 0 0
Málaga
Country [29] 0 0
Spain
State/province [29] 0 0
Pamplona
Country [30] 0 0
Spain
State/province [30] 0 0
Sevilla
Country [31] 0 0
Spain
State/province [31] 0 0
Valencia
Country [32] 0 0
Thailand
State/province [32] 0 0
Songkhla
Country [33] 0 0
Thailand
State/province [33] 0 0
Bangkok
Country [34] 0 0
Thailand
State/province [34] 0 0
Chiang Mai
Country [35] 0 0
Thailand
State/province [35] 0 0
Khon Kaen
Country [36] 0 0
Ukraine
State/province [36] 0 0
Chernivtsi
Country [37] 0 0
Ukraine
State/province [37] 0 0
Kharkiv
Country [38] 0 0
Ukraine
State/province [38] 0 0
Sumy

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Checkpoint Therapeutics, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Novotech (Australia) Pty Limited
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03212404
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
James Oliviero
Address 0 0
Country 0 0
Phone 0 0
001-212-574-2830
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03212404