- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03838848
KN046 in Patients With Advanced Non-small Cell Lung Cancer
February 28, 2023 updated by: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
A Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of KN046 in Patients With Advanced Non-small Cell Lung Cancer
This is a phase II, open label, multicenter study in subjects with advanced non-small cell lung cancer.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
A Phase 2 Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of KN046 in Subjects with Advanced Non-small Cell Lung Cancer
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yong Gui
- Phone Number: 86-21-65115006
- Email: fkyygcp@163.com
Study Contact Backup
- Name: Wei Li, MD
- Phone Number: 86-21-65115006
Study Locations
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Shanghai, China
- Shanghai Pulmonary Hospital
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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 to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Signed inform consent form(ICF);
- Age ≥ 18 years and ≤ 75 years, male or female;
- Histologically or cytologically documented NSCLC,Stage IV (AJCC Version 8) .
- At least one measurable lesion according to Response Evaluation Criteria In Solid Tumors(RECISIT) v 1.1;
- Biopsy specimens obtained from nonradiated areas within 1 year, formalin-fixed, paraffin-embedded blocks containing tumor tissues suitable for biomarker determination, or 15-20 slides (more slides are encouraged to be provided with a minimum of 8 slides; if less than 8 slides are provided, the subject may also be enrolled after consultation and agreement between the Sponsor and the investigator); and fresh biopsy samples collected within 42 days prior to the first dose are required for determination in Cohorts C, D, and E;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Life expectancy > 12 weeks;
- Female patients and males with partners of childbearing potential should be using highly effective contraceptive measures (failure rate of less than 1% per year). Contraception should be continued for a period of 24 weeks after dosing has been completed.
- Ability to comply with treatment, procedures and pharmacokinetics (PK) sample collection and the required study follow-up procedures
Exclusion Criteria:
- Known brain metastasis or another Central Nervous System (CNS) metastasis that is either symptomatic or untreated.
- Having participated in any interventional clinical study within 28 days prior to drug administration in this study.
- Having received other anti-tumor therapy within 28 days before administration in this study, including traditional Chinese medicine with anti-tumor indications;
- Having received major surgical treatment (such as major abdominal, transthoracic surgery; excluding diagnostic aspiration or peripheral vascular access replacement) within 28 days prior to drug administration in this study;
- Having received radical radiotherapy within 3 months prior to drug administration in this study; palliative radiation therapy within 2 weeks prior to the first dose is allowed, the radiation dose meets the diagnostic and treatment criteria for local palliative treatment, and the radiation coverage is less than 30% of the bone marrow area;
- Subjects who require systemic corticosteroids (≥ 10 mg/day prednisone or equivalent dose of other corticosteroids) or immunosuppressive therapy within 14 days prior to drug administration in this study; except for inhaled or topical corticosteroids, or physiologic replacement doses of corticosteroids for adrenal insufficiency; short-term (≤ 7 days) corticosteroids are allowed for prophylaxis (e.g., contrast media allergy) or for the treatment of non-autoimmune disorders (e.g., delayed type hypersensitivity due to contact allergens);
- Having received live vaccines (including live attenuated vaccines) within 28 days prior to drug administration in this study;
- Previous or current interstitial pneumonia/pneumopathy; Subjects with active autoimmune diseases or history of autoimmune diseases should be excluded.
- Subjects who have prior or current autoimmune diseases;
- Subjects who have other malignancies within 5 years before the first dose;
- Active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection, Known HIV infection or known history of acquired immune deficient syndrome (AIDS).
- Any unresolved the Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2 toxicities from prior anti-cancer therapy except for vitiligo, alopecia;
- History of allogeneic bone marrow or organ transplantation;
- Prior history of allergic reaction, hypersensitivity reaction, and intolerance to antibody drugs; history of significant allergy to drugs;
- Pregnant and/or lactating women;
- Other conditions that, in the opinion of the investigator, will affect the safety or compliance of the subjects with the study treatment, including but not limited to psychiatric disorders, uncontrolled moderate to severe serous cavity effusions with large amounts of serous cavity effusions or requiring repeated drainage.
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: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort A
Subjects with Non-small Cell Lung Cancer (NSCLC) (failed or did not tolerant to platinum-containing regime and did not treat with programmed cell death protein 1/the programmed death-ligand 1 (PD1/PDL-1) checkpoint inhibitor previously) will receive KN046 3 milligram per kilogram (mg/kg), every other weeks (Q2W)
|
3mg/kg, Q2W, intravenous injection (IV)
Other Names:
5mg/kg, Q2W, intravenous injection (IV)
Other Names:
5mg/kg, Q3W, intravenous injection (IV)
Other Names:
|
Experimental: Cohort B
Subjects with NSCLC (failed or did not tolerant to platinum-containing regime and did not treat with PD1/PDL-1 checkpoint inhibitor previously) will receive KN046 5 mg/kg, Q2W
|
3mg/kg, Q2W, intravenous injection (IV)
Other Names:
5mg/kg, Q2W, intravenous injection (IV)
Other Names:
5mg/kg, Q3W, intravenous injection (IV)
Other Names:
|
Experimental: Cohort C
Subjects with NSCLC (failed or did not tolerant to platinum-containing regime and failed to PD1/PDL-1 checkpoint inhibitor) will receive KN046
|
3mg/kg, Q2W, intravenous injection (IV)
Other Names:
5mg/kg, Q2W, intravenous injection (IV)
Other Names:
5mg/kg, Q3W, intravenous injection (IV)
Other Names:
|
Experimental: Cohort D
1L NSCLC (EGFR-sensitive mutation (Ex19del or L858R), progression after at least one line treatemtn of EGFR TKIs, and no prior systemic platinum-containing chemotherapy), will receive KN046 5 mg/kg Q3W in combination with pemetrexed and carboplatin
|
3mg/kg, Q2W, intravenous injection (IV)
Other Names:
5mg/kg, Q2W, intravenous injection (IV)
Other Names:
5mg/kg, Q3W, intravenous injection (IV)
Other Names:
AUC 5 IV Q3W; total dose calculated according to the Calvert formula, with the highest dose not exceeding 750 mg; 4 cycles.
500 mg/m2, Q3W, intravenous injection (IV)
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Experimental: Cohort E
≥ 2L NSCLC (failure or intolerance of 1L platinum-doublet chemotherapy; and failure of PD-1/PD-L1 checkpoint inhibitor therapy), will receive KN046 in combination with ningetinib
|
3mg/kg, Q2W, intravenous injection (IV)
Other Names:
5mg/kg, Q2W, intravenous injection (IV)
Other Names:
5mg/kg, Q3W, intravenous injection (IV)
Other Names:
Oral, QD
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ORR
Time Frame: 2 years
|
clinical response rate (ORR) as determined by the independent review board (IRC) based on RECIST 1.1 criteria
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2 years
|
DOR
Time Frame: 2 years
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clinical response time (DOR) as determined by the independent review board (IRC) based on RECIST 1.1 criteria
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2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
May 5, 2019
Primary Completion (Actual)
July 30, 2022
Study Completion (Actual)
July 30, 2022
Study Registration Dates
First Submitted
February 1, 2019
First Submitted That Met QC Criteria
February 10, 2019
First Posted (Actual)
February 12, 2019
Study Record Updates
Last Update Posted (Actual)
March 2, 2023
Last Update Submitted That Met QC Criteria
February 28, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antineoplastic Agents
- Immunologic Factors
- Folic Acid Antagonists
- Carboplatin
- Antibodies
- Immunoglobulins
- Pemetrexed
Other Study ID Numbers
- KN046-201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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Jiangsu Alphamab Biopharmaceuticals Co., LtdCompleted
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Jiangsu Alphamab Biopharmaceuticals Co., LtdCompletedEsophageal Squamous Cell CarcinomaChina
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Alphamab (Australia) Co Pty Ltd.Unknown
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Jiangsu Alphamab Biopharmaceuticals Co., LtdTerminated
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Jiangsu Alphamab Biopharmaceuticals Co., LtdActive, not recruitingSquamous Non-small-cell Lung CancerChina
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Suzhou Zelgen Biopharmaceuticals Co.,LtdJiangsu Alphamab Biopharmaceuticals Co., LtdRecruitingAdvanced Gastrointestinal TumorsChina
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Peking UniversityJiangsu Alphamab Biopharmaceuticals Co., LtdCompletedHER2 Positive Solid TumorChina
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Peking University Cancer Hospital & InstituteNot yet recruitingHER2-positive Colorectal Cancer | HER2-positive Biliary Tract CancerChina
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Weill Medical College of Cornell UniversityJiangsu Alphamab Biopharmaceuticals Co., LtdTerminatedThymic CarcinomaUnited States