Health TrialsbyHealthPanel

A Study of KC1036 in Adolescents With Advanced Ewing Sarcoma

ConditionEwing Sarcoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-18
SponsorBeijing Konruns Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • KC1036

    Drug

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: KC1036Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse events (AEs)

Incidence of treatment-related AEs

Time frame
approximately 3 years

Secondary outcomes

1

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.

Time frame
approximately 3 years
2

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.

Time frame
approximately 3 years
3

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.

Time frame
approximately 3 years
4

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.

Time frame
approximately 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Konruns Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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