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

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 .

Study Overview

• Status: Completed
• Conditions: Lymphoma; Advanced Solid Tumors
• Intervention / Treatment: Drug: KN046

• Study Type: Interventional
• Enrollment (Actual): 139
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China
      • Fujian Medical University Union Hospital
    • Fuzhou, Fujian, China
      • Fujian Cancer Hospital
    • Xiamen, Fujian, China
      • The first affiliated hospital of xiamen university
  • Guangdong
    • Guangzhou, Guangdong, China
      • Sun Yat-sen University Cancer Center
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-sen University Cancer Center
    • Guangzhou, Guangdong, China
      • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
  • Henan
    • Zhengzhou, Henan, China
      • Henan Cancer Hospital
    • Zhengzhou, Henan, China
      • The first affiliated hospital of Zhengzhou university
  • Shandong
    • Linyi, Shandong, China
      • Linyi Cancer Hospital
  • Shanghai
    • Shanghai, Shanghai, China
      • Shanghai East Hospital
  • Sichuan
    • Chengdu, Sichuan, China
      • Chengdu Seventh People's Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China
      • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KN046	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2018
• Primary Completion (Actual): January 3, 2023
• Study Completion (Actual): February 2, 2023

Study Registration Dates

• First Submitted: October 31, 2018
• First Submitted That Met QC Criteria: November 6, 2018
• First Posted (Actual): November 7, 2018

Study Record Updates

• Last Update Posted (Actual): June 9, 2023
• Last Update Submitted That Met QC Criteria: June 8, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma
• Other Study ID Numbers: KN046-CHN-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No