Evaluating KC1036 for advanced thymic tumors

A Single-arm, Open, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of KC1036 in the Patients with Advanced Recurrent or Metastatic Thymic Tumors

This study is testing a new medication called KC1036 to see if it can help people with advanced thymic tumors feel better and manage their disease.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Beijing Konruns Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 2 sites (Shanghai, Shanghai Municipality and 1 other locations)
• Trial ID: NCT05683886 on ClinicalTrials.gov

What this trial studies

This is a single-arm, open-label, multicentric phase II study aimed at assessing the efficacy and safety of KC1036 in patients with advanced recurrent or metastatic thymoma or thymic carcinoma. Participants will receive oral KC1036 at a dosage of 60 mg once daily, with treatment cycles lasting 21 days. The study will monitor safety every 21 days and evaluate tumor response every two cycles until disease progression, unacceptable toxicity, or patient withdrawal occurs. The study addresses an urgent clinical need for effective therapies in this rare type of thoracic tumor.

Who should consider this trial

Good fit: Ideal candidates include patients with advanced recurrent or metastatic thymoma or thymic carcinoma who have failed first-line chemotherapy.

Not a fit: Patients with thymus neuroendocrine tumors or known central nervous system metastases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced thymic tumors who have limited treatment choices.

How similar studies have performed: Previous phase I studies have shown promising therapeutic effects of KC1036 in patients with advanced thymic tumors, indicating potential for success in this phase II study.

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.

Where this trial is running

Shanghai, Shanghai Municipality and 1 other locations

• Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
• West China Hospital — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Principal investigator: Yongsheng Wang, Ph.D — West China Hospital
• Study coordinator: Yongsheng Wang, Ph.D

Conditions Thymic Tumors