Actively Recruiting
A Single-arm, Open, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of KC1036 in Patients with Advanced Recurrent or Metastatic Thymic Tumors
Led by Beijing Konruns Pharmaceutical Co., Ltd. · Updated on 2024-10-17
30
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of KC1036 in patients with advanced recurrent or metastatic thymoma or thymic carcinoma, which are rare types of thoracic tumors. This phase II, open-label, single-arm study aims to address the urgent need for effective treatments in patients who have not benefited from first-line chemotherapy. Previous phase I studies showed promising results for KC1036, supporting further investigation. Participants will take 60 mg of KC1036 orally once daily in 21-day treatment cycles. Safety assessments will occur every 21 days, and tumor responses will be evaluated every two cycles. Treatment continues until the disease progresses, unacceptable side effects occur, or the patient chooses to stop. This multicenter study is sponsored by Beijing Konruns Pharmaceutical Co., Ltd. During the study, participants will undergo regular evaluations including tumor imaging to measure response and safety monitoring over approximately two years. Researchers will assess outcomes such as objective response rate, progression-free survival, disease control rate, duration of response, and adverse events. The study includes adults aged 18 to 75 with confirmed thymic tumors and measurable lesions, requiring ongoing monitoring throughout participation.
CONDITIONS
Brief 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
- 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
- Eastern Cooperative Oncology Group performance status score 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...
- Thymus neuroendocrine tumors
- Known central nervous system metastasis or 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 short intolerance cycles
- Prior PD-1 / PD-L1 antibody combined with small molecule VEGFR-TKI
- Participation in other clinical trials within 4 weeks before enrollment
- Recent prior anti-tumor therapies within specified time frames
- Unresolved toxicities from prior therapies except alopecia
- Unhealed skin wounds, ulcers, or fractures
- Uncontrolled pleural effusion, ascites, or pericardial effusion
- Active autoimmune diseases such as myasthenia gravis or lupus
- Need for immunosuppressive or hormone therapy within 2 weeks before enrollment
- Active bacterial, viral, or fungal infections; recent fever over 38.5°C
- Positive for hepatitis B, hepatitis C, or HIV infections
- Pregnant or lactating women
- No contraception use during study and 6 months after
- Insufficient compliance as evaluated by investigator
- Investigator judgment of unsuitability for trial participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 2 years
Participants receive continuous treatment with oral KC1036 60 mg once daily. Treatment cycles last 21 days each, with safety assessments every 21 days and tumor assessments every 42 days. Treatment continues until disease progression, unacceptable toxicity, or participant refusal.
Visits every 21 days for safety assessments and every 42 days for tumor assessments
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
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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