A Study of KC1036 in Patients with Advanced Thymic Tumors

NCT05683886 | Recruiting Phase 2

• 1 other identifier: KC1036-II-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

This is a single arm，open-label, multicentric, phase II study to evaluate the efficacy and safety of KC1036 in patients with advanced recurrent or metastatic thymoma or thymic carcinoma.

Conditions

Thymic Tumors

Outcome Measures

Primary 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.

  approximately 2 year

Secondary Outcomes (4)

• Progression-free survival (PFS)

  approximately 2 year

• Disease Control Rate (DCR)

  approximately 2 year

• Duration of Response (DOR)

  approximately 2 year.

• Adverse events (AEs)

  approximately of 2 year

Study Arms (1)

KC1036

EXPERIMENTAL

60mg QD

Drug: KC1036

Interventions

KC1036 DRUG

Patients take 60mg QD of KC1036 for the efficacy and safety study. KC1036 are given orally once daily, 21 days as a cycle.

KC1036

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with thymoma or thymic carcinoma confirmed by cytologically or histologically (WHO Classification of Thoracic Tumors 5th ed), including all pathological subtypes;
• Patients with advanced recurrent, unresectable and/or metastatic thymic tumor as defined by the Masaoka-Koga stage;
• Subsequent relapse of disease following first-line systemic chemotherapy;
• Patients with at least one measurable lesion as defined by RECIST V1.1; Measurable lesions located within the radiation field of previous radiotherapy or after local treatment can also be selected as target lesions if progression is confirmed.
• Eastern Cooperative Oncology Group performance status score of 0 or 1;
• Life expectancy \> 12 weeks;
• Adequate organ and marrow function;
• Patients should participate in the study voluntarily and sign informed consent.

You may not qualify if:

• Patients with thymus neuroendocrine tumors;
• Any patient who is known to have central nervous system (CNS) metastasis or imaging shows a risk of CNS metastasis;
• Previous (within the last 5 years) or current malignancies at other sites;
• Gastrointestinal abnormalities;
• Cardiovascular and cerebrovascular diseases;
• Patients who have previous treatment with small molecule VEGFR-TKI (except patients whose treatment cycle is less than 2 weeks due to intolerance or other reasons); Patients who have previous treatment with PD-1 / PD-L1 antibody combined with small molecule VEGFR-TKI;
• Involved in other clinical trials within 4 weeks before enrollment; Prior anti-tumor therapies with chemotherapy, cytotherapy, immunotherapy, operation (Interventional therapy excepted) within 4 weeks 4 weeks before enrollment; Prior radiotherapy (palliative radiotherapy excepted) within 2 weeks; Prior small-molecule targeted therapy within 2 weeks or 5 half-lives.
• Presence of unresolved toxicities from prior anti-tumor therapy, defined as having not resolved to NCI CTCAE V5.0 grade 0 or 1 with the exception of alopecia;
• Skin wound, surgical site, wound site, mucous membrane severe ulcer or fracture comfirmed as having not recovered;
• Uncontrolled mass pleural effusion, ascites, and pericardial effusion;
• Active autoimmune diseases: Myasthenia gravis, pure red cell aplastic anemia, systemic lupus erythematosus, inflammatory bowel disease, etc;
• Need immunosuppressive agents or hormone therapy for immunosuppression, , and still need immunosuppressive therapy within 2 weeks before enrollment;
• Active bacterial, viral or fungal infection; Fever of unknown cause (\> 38.5℃) occurred within 2 weeks before enrollment;
• Patients who are positive for both Hepatitis B surface antigen (HBsAg) and hepatitis B virus deoxyribonucleic acid (HBV-DNA) quantification results; Patients who are positive for both hepatitis C virus antibody (HCAB) and hepatitis C virusribonucleic acid (HCV-RNA) quantification results; Patients who are positive for human immunodeficiency virus (HIV);
• Pregnant or lactating women;

Sponsors & Collaborators

• Beijing Konruns Pharmaceutical Co., Ltd.: lead

Study Sites (2)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

West China Hospital

Chengdu, Sichuan, China

RECRUITING

MeSH Terms

Conditions

Thymus Neoplasms

Condition Hierarchy (Ancestors)

Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Yongsheng Wang, Ph.D

  West China Hospital

  PRINCIPAL INVESTIGATOR

• Wentao Fang, Ph.D

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongsheng Wang, Ph.D

CONTACT

18980602258; Wangys75@gmail.com

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: January 5, 2023
• First Posted: January 13, 2023
• Study Start: February 22, 2023
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2026
• Last Updated: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)