Back to resultsKN046 in Subjects With Advanced Solid Tumors and Lymphoma
Primary Purpose
Advanced Solid Tumors, Lymphoma
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
KN046
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Solid Tumors
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent; willing and able to complete all required procedures of study.
- With advanced-stage or metastatic tumor (unresectable) and experienced progression since last anti-tumor treatment; standard therapy is not available or rejected.
- Subjects must have at least one measurable lesion in advanced solid tumors, at least one measurable or assessable lesion in NK/T cell lymphoma.
- ECOG performance status of 0 or 1.
- Subject must have adequate organ function.
- 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 PK sample collection and the required study follow-up procedures.
Exclusion Criteria:
- Known brain metastasis or other CNS metastasis that is either symptomatic or untreated.
- Is currently participating or has participated in a study of an investigational drug within 4 weeks prior to the first dose of trial treatment.
- Patients who have received immune checkpoint proteins/antibody/medicine (including PD-1, PD-L1, etc) for treatment.
- Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management.
- Subjects with active autoimmune diseases or history of autoimmune diseases should be excluded.
- Active HBV or HCV infection.
- Known HIV infection or known history of acquired immune deficient syndrome (AIDS).
- Any unresolved CTCAE Grade ≥ 2 toxicities from prior anti-cancer therapy with the exception of vitiligo, alopecia.
- Patients who have serious hypersensitive reaction to monoclonal antibodies, and have history of uncontrolled allergic asthma.
Sites / Locations
- Fujian Cancer Hospital
- Fujian Medical University Union Hospital
- The First Affiliated Hospital of Xiamen University
- Sun Yat-sen University Cancer Center
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University
- Sun Yat-sen University Cancer Center
- Henan Cancer Hospital
- The First Affiliated Hospital of Zhengzhou University
- LINYI Cancer Hospital
- Shanghai East Hospital
- Chengdu Seventh People's Hospital
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
- Zhejiang Cancer Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
KN046
Arm Description
Outcomes
Primary Outcome Measures
In the dose escalation part, number of participants with dose limiting toxicity (DLT).
In the dose expansion part,Objective response rate (ORR).
Objective response is defined as complete response (CR) or partial response (PR)
In the dose expansion part, Duration of response (DoR).
Duration of response is defined as the time period from the date of initial independent review committee assessed CR or PR until the date of PD or death from any cause, whichever occurs first.
Secondary Outcome Measures
Full Information
NCT ID
NCT03733951
First Posted
October 31, 2018
Last Updated
June 8, 2023
Sponsor
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT03733951
Brief Title
KN046 in Subjects With Advanced Solid Tumors and Lymphoma
Official Title
An Open-Label, Multicenter, Dose-Escalation and Expansion Phase Ia/Ib Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of KN046 Monotherapy in Subjects With Advanced Solid Tumors and Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
December 18, 2018 (Actual)
Primary Completion Date
January 3, 2023 (Actual)
Study Completion Date
February 2, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a phase Ia/Ib, open-label, multicenter, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of KN046 in subjects with advanced solid tumors and lymphoma .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Tumors, Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
139 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KN046
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
KN046
Intervention Description
Phase Ia：Intravenous (IV) infusions, 1,3 and 5 milligrams per kilogram (mg/kg) every 2 weeks.
Phase Ib：Intravenous (IV) infusions, 1 ,3 or 3, 5 milligrams per kilogram (mg/kg) every 2 weeks, the dose of phase Ib based on the result of phase Ia.
Primary Outcome Measure Information:
Title
In the dose escalation part, number of participants with dose limiting toxicity (DLT).
Time Frame
During the first 4 weeks of treatment.
Title
In the dose expansion part,Objective response rate (ORR).
Description
Objective response is defined as complete response (CR) or partial response (PR)
Time Frame
up to 2 years.
Title
In the dose expansion part, Duration of response (DoR).
Description
Duration of response is defined as the time period from the date of initial independent review committee assessed CR or PR until the date of PD or death from any cause, whichever occurs first.
Time Frame
up to 2 years.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed informed consent; willing and able to complete all required procedures of study.
With advanced-stage or metastatic tumor (unresectable) and experienced progression since last anti-tumor treatment; standard therapy is not available or rejected.
Subjects must have at least one measurable lesion in advanced solid tumors, at least one measurable or assessable lesion in NK/T cell lymphoma.
ECOG performance status of 0 or 1.
Subject must have adequate organ function.
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 PK sample collection and the required study follow-up procedures.
Exclusion Criteria:
Known brain metastasis or other CNS metastasis that is either symptomatic or untreated.
Is currently participating or has participated in a study of an investigational drug within 4 weeks prior to the first dose of trial treatment.
Patients who have received immune checkpoint proteins/antibody/medicine (including PD-1, PD-L1, etc) for treatment.
Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management.
Subjects with active autoimmune diseases or history of autoimmune diseases should be excluded.
Active HBV or HCV infection.
Known HIV infection or known history of acquired immune deficient syndrome (AIDS).
Any unresolved CTCAE Grade ≥ 2 toxicities from prior anti-cancer therapy with the exception of vitiligo, alopecia.
Patients who have serious hypersensitive reaction to monoclonal antibodies, and have history of uncontrolled allergic asthma.
Facility Information:
Facility Name
Fujian Cancer Hospital
City
Fuzhou
State/Province
Fujian
Country
China
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
Country
China
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
State/Province
Fujian
Country
China
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
LINYI Cancer Hospital
City
Linyi
State/Province
Shandong
Country
China
Facility Name
Shanghai East Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Chengdu Seventh People's Hospital
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
12. IPD Sharing Statement
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KN046 in Subjects With Advanced Solid Tumors and Lymphoma
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