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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • KC1036

    Drug

    Patients take 60mg QD of KC1036 for the efficacy and safety study. KC1036 are given orally once daily, 21 days as a cycle.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: KC1036Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

Overall response rate (ORR) was defined as the percentage of participants with a best overall complete response (CR) or partial response (PR) per RECIST 1.1.

Time frame
approximately 2 year

Secondary outcomes

1

Progression-free survival (PFS)

Progression-free survival (PFS) was defined as the time from the start date of study drug to the date of the first radiologically documented progressive disease (PD) per RECIST 1.1 or death due to any cause.

Time frame
approximately 2 year
2

Disease Control Rate (DCR)

Disease Control Rate (DCR) was defined as the percentage of participants with a best overall complete response (CR), partial response (PR), or stable disease (SD) per RECIST 1.1.

Time frame
approximately 2 year
3

Duration of Response (DOR)

Duration of response (DOR) was defined as the time from first documented response (partial response (PR) or complete response (CR)) to the date of first documented disease progression (PD) or death due to any cause, among patients with a confirmed PR or CR per RECIST 1.1.

Time frame
approximately 2 year.
4

Adverse events (AEs)

Incidence of treatment-related AEs

Time frame
approximately of 2 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Konruns Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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