Clinical trial · Interventional
A Study of KC1036 in Patients with Advanced Thymic Tumors
A Single-arm, Open, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of KC1036 in the Patients with Advanced Recurrent or Metastatic Thymic Tumors
NCT05683886CI-TRIAL-00081686recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single arm,open-label, multicentric, phase II study to evaluate the efficacy and safety of KC1036 in patients with advanced recurrent or metastatic thymoma or thymic carcinoma.
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 Tumors | Thymus Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KC1036 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- KC1036
- description
- 60mg QD
- interventionNames
- Drug: KC1036
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- approximately 2 year
- description
- Overall response rate (ORR) was defined as the percentage of participants with a best overall complete response (CR) or partial response (PR) per RECIST 1.1.
Secondary outcomes (4)
- measure
- Progression-free survival (PFS)
- timeFrame
- approximately 2 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with thymoma or thymic carcinoma confirmed by cytologically or histologically (WHO Classification of Thoracic Tumors 5th ed), including all pathological subtypes; * Patients with advanced recurrent, unresectable and/or metastatic thymic tumor as defined by the Masaoka-Koga stage; * Subsequent relapse of disease following first-line systemic chemotherapy; * Patients with at least one measurable lesion as defined by RECIST V1.1; Measurable lesions located within the radiation field of previous radiotherapy or after local treatment can also be selected as target lesions if progression is confirmed. * Eastern Cooperative Oncology Group performance status score of 0 or 1; * Life expectancy \> 12 weeks; * Adequate organ and marrow function; * Patients should participate in the study voluntarily and sign informed consent. Exclusion Criteria: * Patients with thymus neuroendocrine tumors; * Any patient who is known to have central nervous system (CNS) metastasis or imaging shows a risk of CNS metastasis; * Previous (within the last 5 years) or current malignancies at other sites; * Gastrointestinal abnormalities; * Cardiovascular and cerebrovascular diseases; * Patients who have previous treatment with small molecule VEGFR-TKI (except patients whose treatment cycle is less than 2 weeks due to intolerance or other reasons); Patients who have previous treatment with PD-1 / PD-L1 antibody combined with small molecule VEGFR-TKI; * Involved in other clinical trials within 4 weeks before enrollment; Prior anti-tumor therapies with chemotherapy, cytotherapy, immunotherapy, operation (Interventional therapy excepted) within 4 weeks 4 weeks before enrollment; Prior radiotherapy (palliative radiotherapy excepted) within 2 weeks; Prior small-molecule targeted therapy within 2 weeks or 5 half-lives. * Presence of unresolved toxicities from prior anti-tumor therapy, defined as having not resolved to NCI CTCAE V5.0 grade 0 or 1 with the exception of alopecia; * Skin wound, surgical site, wound site, mucous membrane severe ulcer or fracture comfirmed as having not recovered; * Uncontrolled mass pleural effusion, ascites, and pericardial effusion; * Active autoimmune diseases: Myasthenia gravis, pure red cell aplastic anemia, systemic lupus erythematosus, inflammatory bowel disease, etc; * Need immunosuppressive agents or hormone therapy for immunosuppression, , and still need immunosuppressive therapy within 2 weeks before enrollment; * Active bacterial, viral or fungal infection; Fever of unknown cause (\> 38.5℃) occurred within 2 weeks before enrollment; * Patients who are positive for both Hepatitis B surface antigen (HBsAg) and hepatitis B virus deoxyribonucleic acid (HBV-DNA) quantification results; Patients who are positive for both hepatitis C virus antibody (HCAB) and hepatitis C virusribonucleic acid (HCV-RNA) quantification results; Patients who are positive for human immunodeficiency virus (HIV); * Pregnant or lactating women; * Patients who do not take contraception during the study period and within 6 months after the study; * Patients with insufficient compliance as evaluated by investigator; * The investigator believes that it is not suitable to patient in this clinical trial.
References
Publications (0)
Data not yet available
No reference posted for this study.