KN046 (a Humanized PD-L1/CTLA4 Bispecific Single Domain Fc Fusion Protein Antibody) in Subjects With Thymic Carcinoma

Phase 2

Terminated

• Conditions: Thymic Carcinoma
• Interventions: Drug: KN046

• Registration Number: NCT04469725
• Lead Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Brief Summary

This is a Phase 2, open-label, multi-center, single arm study in subjects with advanced thymic carcinoma after failure of platinum-based combination chemotherapy. Subjects should have documented progressive disease while on platinum-based combination chemotherapy. If subjects discontinued platinum-based therapy due to reasons other than progressive disease, subjects should have completed at least 2 cycles of platinum-based combination chemotherapy before the commencement of documented progressive disease. Subjects will be treated with KN046 5 milligram per kilogram every 2 weeks.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-07
• Study First Submitted QC: 2020-07-11
• Study First Posted: 2020-07-14
• Study Start: 2020-12-02
• Primary Completion: 2023-07-07
• Study Completion: 2023-07-07
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-10
• Last Update Posted: 2024-03-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Thymic carcinoma	KN046	enrolled subjects will receive KN046 every 2 weeks.

Primary Outcome Measures

Name	Time	Method
ORR	up to 2 years	ORR (best overall response) per RECIST v1.1 calculated as the proportion of subjects with a best overall response defined as confirmed complete response or confirmed partial response (CR+PR) by Independent Review Committee;

Secondary Outcome Measures

Name	Time	Method
DOR	up to 3 years	DOR (duration of response), calculated as the time from the date of the first documented CR or PR to the first documented progression or death due to underlying cancer;
DCR	up to 3 years	DCR (disease control rate), calculated as the proportion of subjects with best overall response of CR, PR, or SD (stable disease);
CBR	up to 3 years	CBR (clinical benefit rate), calculated as the proportion of subjects with best overall response of CR, PR, or SD on at least 24 weeks;
PFS	up to 3 years	PFS (progression free survival), defined as time from first dose of trial treatment to progression or death due to any cause;
TTR	up to 3 years	TTR (time to response), calculated as the time from first dose of trial treatment to first documented response (CR+PR);

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai, China