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

Jiangsu Alphamab Biopharmaceuticals Co., Ltd12 sites in 1 country139 target enrollmentDecember 18, 2018

ConditionsAdvanced Solid Tumors Lymphoma

InterventionsKN046

DrugsKN046

Overview

Phase: Phase 1
Intervention: KN046
Conditions: Advanced Solid Tumors
Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Enrollment: 139
Locations: 12
Primary Endpoint: In the dose expansion part, Duration of response (DoR).
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 .

Registry

clinicaltrials.gov

Start Date

December 18, 2018

End Date

February 2, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Responsible Party

Sponsor

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
•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.

Arms & Interventions

KN046

Intervention: KN046

Outcomes

Primary Outcomes

In the dose expansion part, Duration of response (DoR).

Time Frame: up to 2 years.

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.

In the dose escalation part, number of participants with dose limiting toxicity (DLT).

Time Frame: During the first 4 weeks of treatment.

In the dose expansion part,Objective response rate (ORR).

Time Frame: up to 2 years.

Objective response is defined as complete response (CR) or partial response (PR)