Clinical trial NCT03733951: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lymphoma
Lead sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Sponsor class: INDUSTRY
First posted: 2018-11-07
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 .


Eligibility criteria: Inclusion Criteria:

1. Signed informed consent; willing and able to complete all required procedures of study.
2. With advanced-stage or metastatic tumor (unresectable) and experienced progression since last anti-tumor treatment; standard therapy is not available or rejected.
3. Subjects must have at least one measurable lesion in advanced solid tumors, at least one measurable or assessable lesion in NK/T cell lymphoma.
4. ECOG performance status of 0 or 1.
5. Subject must have adequate organ function.
6. 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.
7. Ability to comply with treatment, procedures and PK sample collection and the required study follow-up procedures.

Exclusion Criteria:

1. Known brain metastasis or other CNS metastasis that is either symptomatic or untreated.
2. Is currently participating or has participated in a study of an investigational drug within 4 weeks prior to the first dose of trial treatment.
3. Patients who have received immune checkpoint proteins/antibody/medicine (including PD-1, PD-L1, etc) for treatment.
4. Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management.
5. Subjects with active autoimmune diseases or history of autoimmune diseases should be excluded.
6. Active HBV or HCV infection.
7. Known HIV infection or known history of acquired immune deficient syndrome (AIDS).
8. Any unresolved CTCAE Grade ≥ 2 toxicities from prior anti-cancer therapy with the exception of vitiligo, alopecia.
9. Patients who have serious hypersensitive reaction to monoclonal antibodies, and have history of uncontrolled allergic asthma.

Primary outcomes:
measure: In the dose escalation part, number of participants with dose limiting toxicity (DLT).
timeFrame: During the first 4 weeks of treatment.
measure: In the dose expansion part,Objective response rate (ORR).
timeFrame: up to 2 years.
measure: In the dose expansion part, Duration of response (DoR).
timeFrame: up to 2 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Linyi
country: China
facility: LINYI Cancer Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
city: Chengdu
country: China
facility: Chengdu Seventh People's Hospital
state: Sichuan
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References: