Thymic TumorsPhase 2NCT05683886
A Study of KC1036 in Patients with Advanced Thymic Tumors
A Phase 2 study testing KC1036 in people with Thymic Tumors, run by Beijing Konruns Pharmaceutical Co., Ltd. at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thymic Tumors
- What is being tested?
- KC1036
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesChina
- Study dates
- 22 Feb 2023to Feb 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
West China Hospital
Chengdu, Sichuan
Yongsheng Wang, Ph.D
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality
Wentao Fang, Ph.D
About this study
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
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.
Read the 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.
- Conditions
- Thymic Tumors
- Being tested
- KC1036
- Medical subject headings
- Thymus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KC1036Drug
Patients take 60mg QD of KC1036 for the efficacy and safety study. KC1036 are given orally once daily, 21 days as a cycle.
| Study group | Role | What they receive |
|---|---|---|
| KC1036 | Experimental | 60mg QD Receives: Drug: KC1036 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: approximately 2 year
Secondary outcomes (4)
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.
Measured: approximately 2 year
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.
Measured: approximately 2 year
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.
Measured: approximately 2 year.
Adverse events (AEs)
Incidence of treatment-related AEs
Measured: approximately of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start22 Feb 2023
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thymic TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Konruns Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yongsheng Wang, Ph.D, Principal investigator, West China HospitalWentao Fang, Ph.D, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05683886
- Sponsor's protocol ID
- KC1036-II-02
- Status last verified
- Oct 2024
- First submitted
- 5 Jan 2023
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05683886
- Acronym / sponsor ID
- KC1036-II-02
- Conditions
- Thymic Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Beijing Konruns Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 13 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KC1036 | Experimental | Drug: KC103660mg QD |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KC1036Patients take 60mg QD of KC1036 for the efficacy and safety study. KC1036 are given orally once daily, 21 days as a cycle. | Drug | KC1036 |
Primary outcome
Objective Response Rate (ORR)
Time frame: approximately 2 year
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.
4 secondary outcomes
Progression-free survival (PFS)
Time frame: approximately 2 year
Disease Control Rate (DCR)
Time frame: approximately 2 year
Duration of Response (DOR)
Time frame: approximately 2 year.
Adverse events (AEs)
Time frame: approximately of 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yongsheng Wang, Ph.D principal investigator
West China Hospital
Wentao Fang, Ph.D principal investigator
Shanghai Chest Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KC1036 in people with Thymic Tumors, run by Beijing Konruns Pharmaceutical Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yongsheng Wang, Ph.D (18980602258, Wangys75@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: approximately 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.