Actively Recruiting
A Study of KC1036 in Patients with Advanced Thymic Tumors
Led by Beijing Konruns Pharmaceutical Co., Ltd. · Updated on 2024-10-17
30
Participants Needed
2
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of KC1036 in Patients with Advanced Thymic Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with thymoma or thymic carcinoma confirmed by cytology or histology, including all pathological subtypes
- Patients with advanced recurrent, unresectable, and/or metastatic thymic tumor as defined by Masaoka-Koga stage
- Disease relapse after first-line systemic chemotherapy
- At least one measurable lesion as defined by RECIST V1.1, including lesions in prior radiation or local treatment areas if progression is confirmed
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Life expectancy greater than 12 weeks
- Adequate organ and marrow function
- Voluntary participation with signed informed consent
You will not qualify if you...
- Patients with thymus neuroendocrine tumors
- Known central nervous system metastasis or imaging showing risk of CNS metastasis
- Previous or current malignancies at other sites within the last 5 years
- Gastrointestinal abnormalities
- Cardiovascular and cerebrovascular diseases
- Prior treatment with small molecule VEGFR-TKI (except if less than 2 weeks due to intolerance) or combined PD-1/PD-L1 antibody with VEGFR-TKI
- Participation in other clinical trials within 4 weeks prior to enrollment
- Prior anti-tumor therapies including chemotherapy, cytotherapy, immunotherapy, or surgery (except interventional therapy) within 4 weeks before enrollment
- Prior radiotherapy (except palliative) within 2 weeks before enrollment
- Prior small-molecule targeted therapy within 2 weeks or 5 half-lives before enrollment
- Unresolved toxicities from prior anti-tumor therapy worse than grade 1 except alopecia
- Unhealed skin wounds, surgical sites, mucous membrane ulcers, or fractures
- Uncontrolled pleural effusion, ascites, or pericardial effusion
- Active autoimmune diseases such as myasthenia gravis, pure red cell aplastic anemia, systemic lupus erythematosus, or inflammatory bowel disease
- Need for immunosuppressive or hormone therapy within 2 weeks before enrollment
- Active bacterial, viral, or fungal infections or fever above 38.5°C within 2 weeks before enrollment
- Positive for hepatitis B surface antigen and HBV-DNA, hepatitis C antibody and HCV-RNA, or HIV
- Pregnant or lactating women
- Not using contraception during the study and for 6 months after
- Insufficient compliance as judged by the investigator
- Investigator's judgment that participation is unsuitable for the patient
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
2
West China Hospital
Chengdu, Sichuan, China
Actively Recruiting
Research Team
Y
Yongsheng Wang, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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