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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-02

Study Completion Date

2023-07-07

Brief Summary

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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.

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Detailed Description

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Conditions

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Thymic Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

subjects enrolled receive KN046

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Thymic carcinoma

enrolled subjects will receive KN046 every 2 weeks.

Group Type EXPERIMENTAL

KN046

Intervention Type DRUG

KN046 5 milligram per kilogram, every 2 weeks

Interventions

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KN046

KN046 5 milligram per kilogram, every 2 weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No