Lung NeoplasmsPhase 1NCT03212404
Phase 1 Study of CK-301 (Cosibelimab) as a Single Agent in Subjects With Advanced Cancers
A Phase 1 study testing CK-301 (cosibelimab) in people with Lung Neoplasms and Carcinoma, Non-Small-Cell Lung, run by Checkpoint Therapeutics, Inc. at 48 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Small Cell
- What is being tested?
- CK-301 (cosibelimab)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 48 sitesin 9 countries
- Study dates
- 20 Sep 2017to Dec 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
48 sites in 9 countries.
48 sites in 9 countries
Russia9 sites
Research Site
Chelyabinsk, 454087
Research Site
Kazan', 420029
Research Site
Murmansk, 183047
Research Site
Novosibirsk, 630108
Research Site
Omsk, 644013
Research Site
Saint Petersburg, 197022
Research Site
Saint Petersburg, 197758
Research Site
Tyumen, 625041
Research Site
Volgograd, 400138
Australia8 sites
Research Site
Benowa, Queensland, 4217
Research Site
Box Hill, Victoria, 3128
Research Site
Buderim, Queensland, 4556
Research Site
Greenslopes, Queensland, 4120
Research Site
Malvern, Victoria, 3144
Research Site
South Brisbane, Queensland, 4101
Research Site
Wollongong, New South Wales, 2500
Research Site
Woolloongabba, Queensland, 4102
Spain7 sites
Research Site
Barcelona
Research Site
Madrid
Research Site
Málaga
Research Site
Pamplona, 31008
Research Site
San Cristóbal de La Laguna, 38320
Research Site
Seville
Research Site
Valencia
France5 sites
Research Site
Besançon, 25030
Research Site
Bordeaux, 33075
Research Site
Grenoble, 38700
Research Site
Lyon, 69495
Research Site
Nice
Poland5 sites
Research Site
Krakow, 31-826
Research Site
Lodz, 90302
Research Site
Lublin, 20064
Research Site
Poznan, 60693
Research Site
Warsaw, 02-781
South Africa5 sites
Research Site
Cape Town, 7700
Research Site
George, 6529
Research Site
Port Elizabeth
Research Site
Pretoria, 0081
Research Site
Soweto, 2013
Thailand5 sites
Research Site
Bangkok, 10210
Research Site
Bangkok, 10330
Research Site
Chiang Mai, 50200
Research Site
Hat Yai, Changwat Songkhla, 90110
Research Site
Khon Kaen, 40002
Ukraine3 sites
Research Site
Chernivtsi, 58013
Research Site
Kharkiv, 61103
Research Site
Sumy, 40022
About this study
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
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.
Read the 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.
- Conditions
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Small Cell, Malignant Mesothelioma, Advanced, Head and Neck Cancer, Melanoma
- Being tested
- CK-301 (cosibelimab)
- Keywords
- Cancer, PD-L1, PDL1, PD-1, PD1, Solid tumors, Anti PD-L1, Non-small cell lung cancer, NSCLC, CK-301, CSCC, Skin cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Small Cell, Mesothelioma, Malignant, Head and Neck Neoplasms, Melanoma, Carcinoma, Merkel Cell, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CK-301 (cosibelimab)Drug
CK-301 will be administered in periods of 28-day cycles.
| Study group | Role | What they receive |
|---|---|---|
| CK-301 (cosibelimab) | Experimental | Part 1 - Dose Escalation; Part 2 - Dose Expansion Receives: Drug: CK-301 (cosibelimab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: Part 2 Only: Every 8 weeks for first 32 weeks, then 12 weeks through study completion, an average of 6 months
Overall Survival (OS)
Measured: 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
Measured: Baseline up to 12 weeks after study completion, an average of 6 months
Pharmacokinetic parameter: AUC (0-infinity) of CK-301
Measured: Baseline up to 12 weeks after study completion, an average of 6 months
Pharmacokinetic parameter: Cmax of CK-301
Measured: Baseline up to 12 weeks after study completion, an average of 6 months
Pharmacokinetic parameter: Tmax of CK-301
Measured: Baseline up to 12 weeks after study completion, an average of 6 months
Pharmacokinetic parameter: T(1/2) of CK-301
Measured: Baseline up to 12 weeks after study completion, an average of 6 months
Number of subjects with anti-CK-301 antibodies
Measured: Baseline up to 12 weeks after study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start20 Sep 2017
- Primary completion18 Nov 2021
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Checkpoint Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212404
- Sponsor's protocol ID
- CK-301-101
- Status last verified
- Jan 2025
- First submitted
- 6 Jul 2017
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 37848259
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03212404
- Acronym / sponsor ID
- CK-301-101
- Conditions
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Small Cell, Malignant Mesothelioma, Advanced, Head and Neck Cancer, Melanoma
- Keywords
- Cancer, PD-L1, PDL1, PD-1, PD1, Solid tumors, Anti PD-L1, Non-small cell lung cancer, NSCLC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Checkpoint Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Study start
- 20 Sep 2017 (actual)
- Primary completion
- 18 Nov 2021 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CK-301 (cosibelimab) | Experimental | Drug: CK-301 (cosibelimab)Part 1 - Dose Escalation; Part 2 - Dose Expansion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CK-301 (cosibelimab)CK-301 will be administered in periods of 28-day cycles. | Drug | CK-301 (cosibelimab) |
Primary outcome
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
10 secondary outcomes
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
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
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
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
Pharmacokinetic parameter: AUC (0-t) of CK-301
Time frame: 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
Pharmacokinetic parameter: Cmax of CK-301
Time frame: 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
Pharmacokinetic parameter: T(1/2) of CK-301
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Derived from this study: PubMed 37848259Clingan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
48 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CK-301 (cosibelimab) in people with Lung Neoplasms and Carcinoma, Non-Small-Cell Lung, run by Checkpoint Therapeutics, Inc. at 48 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in Russia, Australia, Spain, France, Poland and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity (time frame: Up to 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03212404, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.