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A Study of KC1036 in Patients With Advanced Thymic Tumors

Primary Purpose

Thymic Tumors

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
KC1036
Sponsored by
Beijing Konruns Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thymic Tumors

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Chest HospitalRecruiting
  • West China HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

KC1036

Arm Description

60mg QD

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Adverse events (AEs)
Incidence of treatment-related AEs

Full Information

First Posted
January 5, 2023
Last Updated
March 7, 2023
Sponsor
Beijing Konruns Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05683886
Brief Title
A Study of KC1036 in Patients With Advanced Thymic Tumors
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2023 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Konruns Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Thymus tumor is a relatively rare type of thoracic tumor. Patients with thymus tumor who have failed to receive first-line chemotherapy lack of effective therapeutic drugs and clinical need is urgent. Previous phase I study showed that KC1036 has a good therapeutic effect in patients with advanced thymic tumors, and KC1036 is safe and well tolerated in patients with advanced tumors. This study further explored the efficacy and safety of KC1036 in patients with advanced thymic tumors. Patients will receive continuous treatment with oral KC1036 60 mg once daily. Each cycle will be considered as 21 days of treatment; safety was assessed every 21 days. Tumor assessement will be done every two cycles. Treatment should be administered until documented disease progression, unacceptable toxicity, or patient refusal.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thymic Tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
KC1036
Arm Type
Experimental
Arm Description
60mg QD
Intervention Type
Drug
Intervention Name(s)
KC1036
Intervention Description
Patients take 60mg QD of KC1036 for the efficacy and safety study. KC1036 are given orally once daily, 21 days as a cycle.
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
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 Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
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
Title
Disease Control Rate (DCR)
Description
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
Title
Duration of Response (DOR)
Description
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.
Title
Adverse events (AEs)
Description
Incidence of treatment-related AEs
Time Frame
approximately of 2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yongsheng Wang, Ph.D
Phone
18980602258
Email
Wangys75@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongsheng Wang, Ph.D
Organizational Affiliation
West China Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wentao Fang, Ph.D
Organizational Affiliation
Shanghai Chest Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Chest Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wentao Fang, Ph.D
First Name & Middle Initial & Last Name & Degree
Wentao Fang, Ph.D
Facility Name
West China Hospital
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongsheng Wang, Ph.D
First Name & Middle Initial & Last Name & Degree
Yongsheng Wang, Ph.D

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study of KC1036 in Patients With Advanced Thymic Tumors

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