Ewing SarcomaPhase 2NCT06564272
A Study of KC1036 in Adolescents With Advanced Ewing Sarcoma
A Phase 2 study testing KC1036 in people with Ewing Sarcoma, run by Beijing Konruns Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Ewing Sarcoma
- What is being tested?
- KC1036
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 27 Sep 2024to 1 Apr 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 12 and less than 18 years;
- Diagnosed with Ewing sarcoma confirmed by histopathological examination;
- Patients with locally advanced or metastatic Ewing sarcoma that is unresectable or has failed standard treatment, and for whom no other treatment options are available as assessed by the investigator;
- Body weight of ≥30 kg;
- Karnofsky performance status (≥16 years) or Lansky performance status (<16 years) score of ≥60%;
- Patients with at least one measurable lesions according to RECIST v1.1 (Response Evaluation Criteria in Solid Tumors);
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- Expected survival of more than 12 weeks;
- Sufficient organ and bone marrow function;
- Female patients who have started menstruating must have a negative pregnancy test;
- The patient and their legal guardians understand and are willing to participate in the trial, and have signed the informed consent form.
Who cannot join
- Patients with primary central nervous system tumors;
- Presence of central nervous system metastases as diagnosed by imaging;
- History of or concurrent other malignancies within the past 5 years;
- Gastrointestinal abnormalities;
- Cardiovascular or cerebrovascular abnormalities;
- Patients who have previously received VEGFR-TKI small molecule treatment;
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- Currently participating in another therapeutic clinical trial; received any anticancer treatment within 2 weeks or 5 half-lives (whichever is longer) before the start of the study treatment; received whole-brain radiation therapy within 14 days before the start of the study treatment; received stereotactic radiosurgery within 7 days before the start of the study treatment; or received herbal or traditional Chinese medicine for anticancer purposes within 2 weeks before the study treatment;
- Underwent major surgery within 2 months before enrollment or have not fully recovered, or plan to undergo surgery during the current study period;
- Persistent toxicity from previous anticancer treatment that has not improved to ≤ Grade 1 (according to CTCAE v5.0), excluding alopecia;
- Unhealed skin wounds, surgical sites, traumatic sites, severe mucosal ulcers, or fractures;
- Uncontrolled significant pleural effusion, ascites, or pericardial effusion;
- Active bacterial, viral, or fungal infections; unexplained fever >38.5°C within 2 weeks before enrollment;
- Hepatitis B surface antigen (HBsAg) positive with HBV-DNA ≥500 IU/mL or 2500 copies/mL; Hepatitis C virus (HCV) antibody positive with HCV RNA ≥200 IU/mL or positive test results; HIV-positive individuals;
- Presence of psychiatric or neurological disorders; or cognitive impairment;
- Fertile patients (e.g., females who have started menstruating or males who have started ejaculating) who do not agree to use contraception (e.g., birth control pills or condoms) during the study and for 6 months after the study ends;
- Patients with insufficient compliance as evaluated by investigator;
- The investigator believes that it is not suitable to patient in this clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Children's Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100045
Huanming Wang, Ph.D, 010-88324973, wanghuanmin@bch.com.cn
Xin Ni, Ph.D
About this study
Official title: A Phase II Study to Evaluate the Safety and Efficacy of KC1036 in Adolescents Aged 12 and Above With Advanced Ewing Sarcoma
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
- Ewing Sarcoma
- Being tested
- KC1036
- Medical subject headings
- Sarcoma, Ewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KC1036Drug
For patients weighing between 30 kg and less than 50 kg, administer 40 mg QD of KC1036. For patients weighing between 50 kg and less than 70 kg, administer 50 mg QD of KC1036. For patients weighing 70 kg or more, administer 60 mg QD of KC1036. 4 weeks as a cycle.
| Study group | Role | What they receive |
|---|---|---|
| KC1036 | Experimental | oral administration QD Receives: Drug: KC1036 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
Incidence of treatment-related AEs
Measured: approximately 3 years
Secondary outcomes (4)
Objective Response Rate (ORR)
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.
Measured: approximately 3 years
Progression-free survival (PFS)
Progression-free survival (PFS) was defined as the time from the start date of study drug to the date of the first radiologically documented progressive disease (PD) per RECIST 1.1 or death due to any cause.
Measured: approximately 3 years
Disease Control Rate (DCR)
Disease Control Rate (DCR) was defined as the percentage of participants with a best overall complete response (CR), partial response (PR), or stable disease (SD) per RECIST 1.1.
Measured: approximately 3 years
Duration of Response (DOR)
Duration of response (DOR) was defined as the time from first documented response (partial response (PR) or complete response (CR)) to the date of first documented disease progression (PD) or death due to any cause, among patients with a confirmed PR or CR per RECIST 1.1.
Measured: approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start27 Sep 2024 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ewing SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Konruns Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huanmin Wang, Principal investigator, Beijing Children's Hospital Affiliated to Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564272
- Sponsor's protocol ID
- KC1036-PED-01
- Status last verified
- Aug 2024
- First submitted
- 19 Aug 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Evaluate the Safety and Efficacy of KC1036 in Adolescents Aged 12 and Above With Advanced Ewing Sarcoma
- ClinicalTrials.gov ID
- NCT06564272
- Acronym / sponsor ID
- KC1036-PED-01
- Conditions
- Ewing Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Beijing Konruns Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Sep 2024 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 21 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KC1036 | Experimental | Drug: KC1036oral administration QD |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Age between 12 and less than 18 years;
- Diagnosed with Ewing sarcoma confirmed by histopathological examination;
- Patients with locally advanced or metastatic Ewing sarcoma that is unresectable or has failed standard treatment, and for whom no other treatment options are available as assessed by the investigator;
- Body weight of ≥30 kg;
- Karnofsky performance status (≥16 years) or Lansky performance status (<16 years) score of ≥60%;
Key exclusion criteria (17 listed)
- Patients with primary central nervous system tumors;
- Presence of central nervous system metastases as diagnosed by imaging;
- History of or concurrent other malignancies within the past 5 years;
- Gastrointestinal abnormalities;
- Cardiovascular or cerebrovascular abnormalities;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KC1036For patients weighing between 30 kg and less than 50 kg, administer 40 mg QD of KC1036. For patients weighing between 50 kg and less than 70 kg, administer 50 mg QD of KC1036. For patients weighing 70 kg or more, administer 60 mg QD of KC1036. 4 weeks as a cycle. | Drug | KC1036 |
Primary outcome
Adverse events (AEs)
Time frame: approximately 3 years
Incidence of treatment-related AEs
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: approximately 3 years
Progression-free survival (PFS)
Time frame: approximately 3 years
Disease Control Rate (DCR)
Time frame: approximately 3 years
Duration of Response (DOR)
Time frame: approximately 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Huanmin Wang principal investigator
Beijing Children's Hospital Affiliated to Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KC1036 in people with Ewing Sarcoma, run by Beijing Konruns Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xin Ni (010-88324973, nixin@bch.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AEs) (time frame: approximately 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.