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

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

INTRODUCTION

  • Org Study ID: CK-301-101
  • Secondary ID: N/A
  • NCT ID: NCT03212404
  • Sponsor: Checkpoint Therapeutics, Inc.

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.


  • Overall Status
    Recruiting
  • Start Date
    September 20, 2017
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Dose Limiting Toxicity

Primary Outcome 1 - Timeframe: Up to 4 weeks

Primary Outcome 2 - Measure: 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)

Primary Outcome 2 - Timeframe: Screening through 4 weeks after study completion, an average of 6 months

Primary Outcome 3 - Measure: Confirmed Objective Response Rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1)

Primary Outcome 3 - Timeframe: Part 2 Only: Average of 6 months

CONDITION

  • 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
  • Colorectal Cancer
  • Cutaneous Squamous Cell Carcinoma
  • Non Hodgkin Lymphoma
  • Endometrial Cancer

ELIGIBILITY


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.

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: 001-212-574-2830

Email: info@checkpointtx.com

LOCATION

Facility Status Contact
Facility: Research Site
Wollongong, New South Wales 2500
Australia 		Status: Recruiting Contact: N/A
Facility: Research Site
Box Hill, Victoria 3128
Australia 		Status: Recruiting Contact: N/A
Facility: Research Site
Malvern, Victoria 3144
Australia 		Status: Recruiting Contact: N/A
Facility: Research Site
Christchurch, 8140
New Zealand 		Status: Recruiting Contact: N/A
Facility: Research Site
Chelyabinsk, 454087
Russian Federation 		Status: Recruiting Contact: N/A
Facility: Research Site
Kazan, 420029
Russian Federation 		Status: Recruiting Contact: N/A
Facility: Research Site
Murmansk, 183047
Russian Federation 		Status: Recruiting Contact: N/A
Facility: Research Site
Novosibirsk, 630108
Russian Federation 		Status: Recruiting Contact: N/A
Facility: Research Site
Omsk, 644013
Russian Federation 		Status: Recruiting Contact: N/A
Facility: Research Site
Saint Petersburg, 197022
Russian Federation 		Status: Recruiting Contact: N/A
Facility: Research Site
Saint Petersburg, 197758
Russian Federation 		Status: Recruiting Contact: N/A
Facility: Research Site
Tyumen, 625041
Russian Federation 		Status: Recruiting Contact: N/A
Facility: Research Site
Volgograd, 400138
Russian Federation 		Status: Recruiting Contact: N/A
Facility: Research Site
Hat Yai, Songkhla 90110
Thailand 		Status: Recruiting Contact: N/A
Facility: Research Site
Bangkok, 10210
Thailand 		Status: Recruiting Contact: N/A
Facility: Research Site
Bangkok, 10330
Thailand 		Status: Recruiting Contact: N/A
Facility: Research Site
Chiang Mai, 50200
Thailand 		Status: Recruiting Contact: N/A
Facility: Research Site
Khon Kaen, 40002
Thailand 		Status: Recruiting Contact: N/A

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