BridgeMD
New treatment option for Thymic Tumors
Official title A Study of KC1036 in Patients with Advanced Thymic Tumors
ClinicalTrials.gov ID: NCT05683886
What this study is testing
What is KC1036?
KC1036 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for thymic tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients with thymoma or thymic carcinoma confirmed by cytologically or histologically (WHO Classification of Thoracic Tumors 5th ed), including all...
- 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...
- Eastern Cooperative Oncology Group performance status score of 0 or 1;
You likely can't join 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...
See the full eligibility 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...
- 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.
- 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...
- Involved in other clinical trials within 4 weeks before enrollment; Prior anti-tumor therapies with chemotherapy, cytotherapy, immunotherapy, operation (treatment therapy excepted) within 4 weeks 4 weeks before...
- 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)...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China; Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.