Clinical trial NCT04469725: KN046 (a Humanized PD-L1/CTLA4 Bispecific Single Domain Fc Fusion Protein Antibody) in Subjects With Thymic Carcinoma
Official title: A Phase 2, Open-Label, Multi-Center Study to Evaluate Efficacy, Safety and Tolerability of KN046 in Subjects With Thymic Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Thymic Carcinoma
Lead sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Sponsor class: INDUSTRY
First posted: 2020-07-14
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: subjects enrolled receive KN046
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: ORR
timeFrame: up to 2 years
Secondary outcomes:
measure: DOR
timeFrame: up to 3 years
measure: DCR
timeFrame: up to 3 years
measure: CBR
timeFrame: up to 3 years
measure: PFS
timeFrame: up to 3 years
measure: TTR
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Chest Hospital
name: Xiaolong Fu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Remon J, Girard N, Novello S, de Castro J, Bigay-Game L, Bernabe R, Greillier L, Mosquera J, Cousin S, Juan O, Sampayo M, Besse B. PECATI: A Multicentric, Open-Label, Single-Arm Phase II Study to Evaluate the Efficacy and Safety of Pembrolizumab and Lenvatinib in Pretreated B3-Thymoma and Thymic Carcinoma Patients. Clin Lung Cancer. 2022 May;23(3):e243-e246. doi: 10.1016/j.cllc.2021.07.008. Epub 2021 Jul 20.