Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The termination of this study does not involve safety issues. The overall safety of KN046 is good, and no new safety signals have been found. The decision to terminate this study was made due to the adjustment of the sponsor's development strategy.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thymic Carcinoma | Thymus Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KN046 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Thymic carcinoma
- description
- enrolled subjects will receive KN046 every 2 weeks.
- interventionNames
- Drug: KN046
Primary outcomes (1)
- measure
- ORR
- timeFrame
- up to 2 years
- description
- 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 outcomes (5)
- measure
- DOR
- timeFrame
- up to 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDRemon 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. PMID 34393061