NCT05683886 A Study of KC1036 in Patients with Advanced Thymic Tumors
| NCT ID | NCT05683886 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Beijing Konruns Pharmaceutical Co., Ltd. |
| Condition | Thymic Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-02-22 |
| Primary Completion | 2025-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2023-02-22 with a primary completion date of 2025-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Yongsheng Wang, Ph.D
PRINCIPAL INVESTIGATOR
West China Hospital
Frequently Asked Questions
Who can join the NCT05683886 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Thymic Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05683886 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05683886 currently recruiting?
Yes, NCT05683886 is actively recruiting participants. Contact the research team at Wangys75@gmail.com for enrollment information.
Where is the NCT05683886 trial being conducted?
This trial is being conducted at Shanghai, China, Chengdu, China.
Who is sponsoring the NCT05683886 clinical trial?
NCT05683886 is sponsored by Beijing Konruns Pharmaceutical Co., Ltd.. The principal investigator is Yongsheng Wang, Ph.D at West China Hospital. The trial plans to enroll 30 participants.