A Study of KC1036 in Patients with Advanced Thymic Tumors
ConditionThymic Tumors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing Konruns Pharmaceutical Co., Ltd.
About this trial
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
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- KC1036
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov