KN046 in Subjects With Advanced Solid Tumors and Lymphoma
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
1 other identifier
interventional
139
1 country
13
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2018
Longer than P75 for phase_1
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2018
CompletedFirst Posted
Study publicly available on registry
November 7, 2018
CompletedStudy Start
First participant enrolled
December 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 3, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 2, 2023
CompletedJune 9, 2023
June 1, 2023
4 years
October 31, 2018
June 8, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
In the dose escalation part, number of participants with dose limiting toxicity (DLT).
During the first 4 weeks of treatment.
In the dose expansion part,Objective response rate (ORR).
Objective response is defined as complete response (CR) or partial response (PR)
up to 2 years.
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.
up to 2 years.
Study Arms (1)
KN046
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Fujian Cancer Hospital
Fuzhou, Fujian, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
LINYI Cancer Hospital
Linyi, Shandong, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Chengdu Seventh People's Hospital
Chengdu, Sichuan, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Related Publications (1)
Ma Y, Xue J, Zhao Y, Zhang Y, Huang Y, Yang Y, Fang W, Guo Y, Li Q, Ge X, Sun J, Zhang B, Zhang Y, Xiao J, Zhang L, Zhao H. Phase I trial of KN046, a novel bispecific antibody targeting PD-L1 and CTLA-4 in patients with advanced solid tumors. J Immunother Cancer. 2023 Jun;11(6):e006654. doi: 10.1136/jitc-2022-006654.
PMID: 37263673DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2018
First Posted
November 7, 2018
Study Start
December 18, 2018
Primary Completion
January 3, 2023
Study Completion
February 2, 2023
Last Updated
June 9, 2023
Record last verified: 2023-06