A Study of KC1036 in Adolescents With Advanced Ewing Sarcoma

Sponsor
Beijing Konruns Pharmaceutical Co., Ltd.
Study ID
NCT06564272
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Ewing Sarcoma

Eligibility Criteria

Sex
ALL
Age
12 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Aug 21, 2024
Start date
Sep 27, 2024
Status verified
Aug 2024
Primary completion
Apr 1, 2027
Completion
Apr 1, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: KC1036
    oral administration QD

Primary Outcome Measure

Adverse events (AEs) [ Time Frame: approximately 3 years ]

Central Contacts

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