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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04469725

Enrollment

Registered

2020-07-14

Start date

2020-12-02

Completion date

2023-07-07

Last updated

2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thymic Carcinoma

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.

Interventions

DRUGKN046

KN046 5 milligram per kilogram, every 2 weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

subjects enrolled receive KN046

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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);

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026