To hear about similar clinical trials, please enter your email below
Trial Title:
A Study of KC1036 in Patients with Advanced Thymic Tumors
NCT ID:
NCT05683886
Condition:
Thymic Tumors
Conditions: Official terms:
Thymus Neoplasms
Thymoma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
KC1036
Description:
Patients take 60mg QD of KC1036 for the efficacy and safety study. KC1036 are given
orally once daily, 21 days as a cycle.
Arm group label:
KC1036
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.
Detailed description:
Thymus tumor is a relatively rare type of thoracic tumor. Patients with thymus tumor who
have failed to receive first-line chemotherapy lack of effective therapeutic drugs and
clinical need is urgent. Previous phase I study showed that KC1036 has a good therapeutic
effect in patients with advanced thymic tumors, and KC1036 is safe and well tolerated in
patients with advanced tumors. This study further explored the efficacy and safety of
KC1036 in patients with advanced thymic tumors.
Patients will receive continuous treatment with oral KC1036 60 mg once daily. Each cycle
will be considered as 21 days of treatment; safety was assessed every 21 days. Tumor
assessement will be done every two cycles. Treatment should be administered until
documented disease progression, unacceptable toxicity, or patient refusal.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- Patients who do not take contraception during the study period and within 6 months
after the study;
- Patients with insufficient compliance as evaluated by investigator;
- The investigator believes that it is not suitable to patient in this clinical trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Chest Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Wentao Fang, Ph.D
Facility:
Name:
West China Hospital
Address:
City:
Chengdu
Country:
China
Status:
Recruiting
Contact:
Last name:
Yongsheng Wang, Ph.D
Start date:
February 22, 2023
Completion date:
February 2026
Lead sponsor:
Agency:
Beijing Konruns Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Beijing Konruns Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05683886