Actively Recruiting
A Study of KC1036 in Adolescents With Advanced Ewing Sarcoma
Led by Beijing Konruns Pharmaceutical Co., Ltd. · Updated on 2024-08-23
30
Participants Needed
1
Research Sites
183 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This open-label, single-arm clinical trial is to evaluate the safety and effectiveness of KC1036 in treating adolescents aged 12 and above with advanced Ewing sarcoma. Participants will take KC1036 once daily, with each treatment cycle lasting 4 weeks.
CONDITIONS
Official Title
A Study of KC1036 in Adolescents With Advanced Ewing Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 12 and less than 18 years
- Confirmed diagnosis of Ewing sarcoma by histopathological examination
- Locally advanced or metastatic Ewing sarcoma that is unresectable or has failed standard treatment with no other options
- Body weight of at least 30 kg
- Karnofsky performance status (≥16 years) or Lansky performance status (<16 years) score of at least 60%
- At least one measurable lesion according to RECIST v1.1
- Expected survival of more than 12 weeks
- Sufficient organ and bone marrow function
- Negative pregnancy test for females who have started menstruating
- Patient and legal guardians understand the trial and have signed informed consent
You will not qualify if you...
- Primary central nervous system tumors
- Central nervous system metastases diagnosed by imaging
- History or concurrent other malignancies within the past 5 years
- Gastrointestinal abnormalities
- Cardiovascular or cerebrovascular abnormalities
- Previous treatment with VEGFR-TKI small molecule therapy
- Participation in another therapeutic clinical trial or recent anticancer treatment within 2 weeks or 5 half-lives, whole-brain radiation within 14 days, stereotactic radiosurgery within 7 days, or herbal/traditional Chinese medicine for anticancer purposes within 2 weeks
- Major surgery within 2 months before enrollment or not fully recovered from surgery
- Persistent toxicity from previous anticancer treatment not improved to Grade 1 or better (except alopecia)
- Unhealed wounds, ulcers, fractures, or severe mucosal damage
- Uncontrolled significant pleural effusion, ascites, or pericardial effusion
- Active bacterial, viral, or fungal infections or unexplained fever >38.5°C within 2 weeks before enrollment
- Hepatitis B or C infection with specified viral load, or HIV positive
- Psychiatric, neurological disorders, or cognitive impairment
- Fertile patients unwilling to use contraception during and for 6 months after the study
- Insufficient compliance as evaluated by investigator
- Investigator judgment deeming unsuitability for the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Children's Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China, 100045
Actively Recruiting
Research Team
X
Xin Ni
CONTACT
H
Huanmin Wang
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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