Actively Recruiting
A Phase II Study to Evaluate the Safety and Efficacy of KC1036 in Adolescents Aged 12 and Above With Advanced Ewing Sarcoma
Led by Beijing Konruns Pharmaceutical Co., Ltd. · Updated on 2024-08-23
30
Participants Needed
1
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 adolescents aged 12 to under 18 years with advanced Ewing sarcoma, a type of cancer that is locally advanced or metastatic and has not responded to standard treatments. This open-label, single-arm Phase II clinical trial focuses on patients with no other treatment options, aiming to assess how well KC1036 works and its safety profile over approximately three years. Participants will take KC1036 orally once daily in 4-week treatment cycles. Dosage depends on body weight: 40 mg daily for those weighing 30 to less than 50 kg, 50 mg daily for 50 to less than 70 kg, and 60 mg daily for 70 kg or more. The study does not involve a comparison group and continues treatment cycles as long as participants meet criteria. During the trial, participants will be monitored for adverse events and various measures of cancer response, including objective response rate, disease control rate, progression-free survival, and duration of response, over about three years. Participants will undergo regular assessments such as imaging to evaluate measurable lesions, organ function tests, and pregnancy tests when applicable. The study includes safety monitoring and requires informed consent from both patients and their legal guardians.
CONDITIONS
Brief 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
- Diagnosed with Ewing sarcoma confirmed by histopathological examination
- Locally advanced or metastatic Ewing sarcoma that is unresectable or has failed standard treatment
- Body weight of at least 30 kg
- Karnofsky performance status (≥16 years) or Lansky performance status (<16 years) score of 60% or higher
- 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 and agree to participate, with 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
- Prior treatment with VEGFR-TKI small molecule agents
- Participation in another therapeutic clinical trial or recent anticancer treatments within 2 weeks or 5 half-lives
- Whole-brain radiation within 14 days or stereotactic radiosurgery within 7 days before study start
- Use of herbal or traditional Chinese medicine for anticancer within 2 weeks before study start
- Major surgery within 2 months before enrollment or planned surgery during the study
- Persistent toxicity from previous anticancer treatment above Grade 1, excluding alopecia
- Unhealed skin wounds, severe mucosal ulcers, fractures
- Uncontrolled significant pleural effusion, ascites, or pericardial effusion
- Active infections or unexplained fever above 38.5°C within 2 weeks before enrollment
- Positive hepatitis B with high viral load, hepatitis C with high RNA, or HIV-positive
- Psychiatric or neurological disorders or cognitive impairment
- Fertile patients not agreeing to contraception during and 6 months after the study
- Insufficient compliance as evaluated by the investigator
- Investigator judgment deeming patient unsuitable for the trial
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 - Repeated 4-week cycles until disease progression or discontinuation
Participants receive oral KC1036 daily in 4-week cycles based on body weight to treat advanced Ewing sarcoma.
Visits occur regularly during treatment cycles as scheduled by the study team
Duration - Up to approximately 3 years
Participants are monitored for safety and efficacy outcomes including adverse events and disease status.
Periodic visits during follow-up to assess health status
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
H
Huanmin Wang
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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