A Study of KC1036 in Adolescents With Advanced Ewing Sarcoma

NCT06564272 | Recruiting Phase 2

• 1 other identifier: KC1036-PED-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ewing Sarcoma

Outcome Measures

Primary Outcomes (1)

• Adverse events (AEs)

  Incidence of treatment-related AEs

  approximately 3 years

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  approximately 3 years

• Progression-free survival (PFS)

  approximately 3 years

• Disease Control Rate (DCR)

  approximately 3 years

• Duration of Response (DOR)

  approximately 3 years

Study Arms (1)

KC1036

EXPERIMENTAL

oral administration QD

Drug: KC1036

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.

KC1036

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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);
• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Beijing Konruns Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Beijing Children's Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 100045, China

RECRUITING

MeSH Terms

Conditions

Sarcoma, Ewing

Condition Hierarchy (Ancestors)

Osteosarcoma; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Study Officials

• Huanmin Wang

  Beijing Children's Hospital Affiliated to Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin Ni

CONTACT

010-88324973; nixin@bch.com.cn

Huanmin Wang

CONTACT

010-88324973; wanghuanmin@bch.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 21, 2024
• Study Start: September 27, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)