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

Thymic Carcinoma Clinical Trial

Official title:

A Phase 2, Open-Label, Multi-Center Study to Evaluate Efficacy, Safety and Tolerability of KN046 in Subjects With Thymic Carcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04469725
• Other study ID #: KN046-205
• Status: Terminated
• Phase: Phase 2
• Start date: December 2, 2020
• Est. completion date: July 7, 2023

Study information

• Verified date: March 2024
• Source: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 95
• Est. completion date: July 7, 2023
• Est. primary completion date: July 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Male or female, =18 years
• Pathologically confirmed diagnosis of thymic carcinoma
• Inoperable or metastatic disease
• Had failed at least one regimen containing platinum-based combination chemotherapy for locally advanced unresectable or metastatic disease
• Baseline measurable disease Exclusion Criteria
• Thymomas, thymolipoma, germ cell tumors, teratomas, seminomas
• Leptomeningeal metastasis or untreated active CNS (central nervous system) metastasis or leptomeningeal metastasis.
• Is currently participating and receiving an investigational drug or has participated in a study of an investigational drug within 4 weeks
• Has received other anti-tumor treatment within 4 weeks
• Major surgery for any reason, except diagnostic biopsy, within 4 weeks of the first administration of trial treatment
• Curative radiation within 3 months of the first dose of trial treatment.
• Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of trial treatment

Related Conditions & MeSH terms

• Carcinoma
• Thymic Carcinoma
• Thymoma

Intervention

Drug:
• KN046
KN046 5 milligram per kilogram, every 2 weeks

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai	Shanghai

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	ORR	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;	up to 2 years
Secondary	DOR	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;	up to 3 years
Secondary	DCR	DCR (disease control rate), calculated as the proportion of subjects with best overall response of CR, PR, or SD (stable disease);	up to 3 years
Secondary	CBR	CBR (clinical benefit rate), calculated as the proportion of subjects with best overall response of CR, PR, or SD on at least 24 weeks;	up to 3 years
Secondary	PFS	PFS (progression free survival), defined as time from first dose of trial treatment to progression or death due to any cause;	up to 3 years
Secondary	TTR	TTR (time to response), calculated as the time from first dose of trial treatment to first documented response (CR+PR);	up to 3 years