KN046 in Subjects With Advanced Solid Tumors and Lymphoma

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03733951
• Other study ID #: KN046-CHN-001
• Status: Completed
• Phase: Phase 1
• Start date: December 18, 2018
• Est. completion date: February 2, 2023

Study information

• Verified date: June 2023
• Source: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: February 2, 2023
• Est. primary completion date: January 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Lymphoma

Intervention

Drug:
• KN046
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.

Locations

Country	Name	City	State
China	Chengdu Seventh People's Hospital	Chengdu	Sichuan
China	Fujian Cancer Hospital	Fuzhou	Fujian
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	Sir Run Run Shaw Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	LINYI Cancer Hospital	Linyi	Shandong
China	Shanghai East Hospital	Shanghai	Shanghai
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian
China	Henan Cancer Hospital	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In the dose escalation part, number of participants with dose limiting toxicity (DLT).		During the first 4 weeks of treatment.
Primary	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.
Primary	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.