Effectiveness，Safety，Thymic CancerNCT04975061
A Phase 2 Clinical Study of YY-20394 in Patients With Relapsed/Refractory Thymic Cancer
An observational study of Effectiveness，Safety，Thymic Cancer, run by Shanghai YingLi Pharmaceutical Co. Ltd..
Trial summary
This study is a single-arm, open, multi-center phase II clinical trial, the main purpose of which is to evaluate the effectiveness and safety of YY-20394 in the treatment of patients with relapsed/refractory thymic cancer. The research adopts the Simon two-stage design method, which is carried out in two stages. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Effectiveness，Safety，Thymic Cancer
- What is being tested?
- YY-20394
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2021to 30 Dec 2022
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with histologically confirmed thymic cancer (WHO classification), including all subtypes; inoperable advanced disease (Masaoka-Koga staging); progressed after receiving at least one systemic chemotherapy.
Who may be able to join
- The age is 18 years old and above;
- Patients with thymic cancer confirmed histologically (WHO classification), including all subtypes;
- Inoperable advanced disease (Masaoka-Koga staging), which progresses after receiving at least one systemic chemotherapy;
- Volunteer to participate in this clinical trial, understand the research procedures and be able to sign written informed consent;
- ECOG performance status (PS) level 0 to 1;
- Estimated survival time ≥ 3 months;
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- According to the RECIST1.1 standard, the patient has at least one measurable lesion;
- Be able to provide tissues from archive tissue samples or newly obtained core or excision biopsy tissues of tumor lesions;
- According to the judgment of the investigator, it can comply with the test plan;
- Past anti-tumor therapy (including chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy) from the end to the first use of the study drug washout period ≥ 4 weeks, including oral fluorouracil and small molecule targeted drugs Washout period ≥ 2 weeks;
- Good organ function level:
- Bone marrow function needs to meet:
- Absolute neutrophil count (ANC) ≥1.5×109/L;
- Platelet count (PLT) ≥80×109/L;
- Hemoglobin (Hb) ≥9 g/dL;
- Liver function
- Serum total bilirubin (TBIL) ≤1.5 x ULN (except for Gilbert syndrome, total bilirubin ≤2.5 x ULN);
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0×ULN (or recorded liver transfer: 5.0×ULN);
- Kidney function
- Serum creatinine clearance rate (CrCl) ≤1.5 x ULN OR ≥60ml/min (calculated according to Cockcroft-Gault formula);
- Coagulation function
- International normalized ratio (INR) ≤ 1.5 × ULN, unless the subject is receiving anticoagulant therapy, as long as the PT or PTT is within the expected therapeutic range of the anticoagulant; activated partial thrombin time (APTT) ≤ 1.5 × ULN, Unless the subject receives anticoagulant therapy, as long as the PT or PTT is within the expected therapeutic range of the anticoagulant;
- Heart function • Ejection fraction (LVEF) ≥50%; Fridericia method corrected QT interval (QTcF) male <450ms, female <470ms.
Who cannot join
- Suffer from thymic cancer that can be cured by surgery or radiation;
- Those who have used anti-tumor drugs targeting PI3Kδ have progressed (such as being out of the group due to intolerance) outer);
- Suffer from ongoing malignant tumors or other malignant tumors that require active treatment. Skin base Bottom cell carcinoma, except for squamous cell carcinoma of the skin or cervical cancer in situ after potential treatment;
- Known active central nervous system (CNS) metastasis/cancerous meningitis. Previously accepted Subjects of brain metastasis therapy can participate as long as they are stable (there is no evidence of imaging progress at least 4 weeks before the first dose of trial treatment, and any neurological symptoms have returned to baseline levels), and there are no new or enlarged Evidence of brain metastases in patients, and have not used steroids for at least 7 days before the trial treatment;
- Suffered from active autoimmune disease in the past 3 months and required systemic treatment, or Documented history of clinically severe autoimmune disease, or syndrome requiring systemic steroids or immunosuppressive agents. Except subjects with vitiligo or childhood asthma/atherosclerosis, subjects who need intermittent bronchodilators or topical steroid injections, and subjects with hypothyroidism and stable to hormone replacement or Sjorgen syndrome;
- Those who have active viral, bacterial or fungal infections and need treatment (such as pneumonia, etc.);
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- According to the judgment of the investigator, there is a serious harm to the safety of the patient, or affect the completion of the research The accompanying diseases of the study (such as uncontrollable hypertension, uncontrollable diabetes, active interstitial lung disease, etc.);
- People with allergies, or those who are known to have a history of allergies to the components of this medicine;
- The baseline pregnancy test of pregnant women, lactating women, or women with childbearing potential is positive;
- Have a history of immunodeficiency, including HIV test positive, or have other acquired, congenital Sexual immunodeficiency disease, or history of organ transplantation, or allogeneic bone marrow or hematopoietic stem History of cell transplantation;
- Previously suffering from heart diseases, including: (1) angina pectoris; (2) those requiring clinical intervention Arrhythmia; (3) Myocardial infarction; (4) Heart failure; (5) Other researched Other heart diseases judged to be unsuitable for participating in this trial;
- Skin basal cell carcinoma and uterine cancer that have been cured of other malignant tumors in the past 5 years Except for cervical carcinoma in situ;
- People with HBV or HCV infection (defined as HbsAg and/or HbcAb positive and HBV DNA copy number ≥1×104 copy number/ml or ≥2000 IU/ml) or acute or chronic active hepatitis C (HCV) antibodies Positive;
- Live vaccine has been vaccinated within 30 days before the first dose of treatment
About this study
Official title: A Phase 2 Clinical Study of YY-20394 in Patients With Relapsed/Refractory Thymic
This study is a single-arm, open, multi-center phase II clinical trial, the main purpose of which is to evaluate the effectiveness and safety of YY-20394 in the treatment of patients with relapsed/refractory thymic cancer.
The research adopts the Simon two-stage design method, which is carried out in two stages.
Read the detailed description
This study is a single-arm, open, multi-center phase II clinical trial, the main purpose of which is to evaluate the effectiveness and safety of YY-20394 in the treatment of patients with relapsed/refractory thymic cancer.
The research adopts the Simon two-stage design method, which is carried out in two stages.
The first stage:
In the first phase, a single-arm, open, multi-center study was adopted, and YY-20394 monotherapy was given to patients who met the enrollment conditions. The trial enrolled 18 subjects. If ≥2 subjects had ORR (clinical benefit), then enter the second phase, otherwise the trial will be terminated.
The second stage:
Refer to the efficacy data of the first phase to decide whether to conduct the second phase of clinical research.
In the second phase, a single-arm, open, multi-center study was adopted. Patients who met the enrollment conditions were given YY-20394 monotherapy. In the second phase, 40 subjects will continue to be enrolled.
A total of 58 subjects were included in the two stages. During the study period, the investigator judged the best curative effect of all subjects according to the response evaluation criteria in solid tumours (Response evaluation criteria in solid tumours, RECIST 1.1). IRC will use the same standards to evaluate the efficacy of the imaging results of all subjects, and the entire review process will be conducted in accordance with an independent review procedure. The Research Safety Monitoring Committee (SMC) will continue to review the safety of study drugs. SMC will be responsible for monitoring safety data and making decisions on research-related issues, such as study enrollment, dose selection, whether to continue the study, etc.
- Conditions
- Effectiveness，Safety，Thymic Cancer
- Being tested
- YY-20394
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YY-20394Drug
YY-20394 is a small molecule inhibitor.
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Overall response rate consists of complete response and partial response
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start1 Aug 2021 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effectiveness，Safety，Thymic CancerStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai YingLi Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04975061
- Sponsor's protocol ID
- YY-20394-011
- Status last verified
- Jul 2021
- First submitted
- 12 Jul 2021
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Clinical Study of YY-20394 in Patients With Relapsed/Refractory Thymic
- ClinicalTrials.gov ID
- NCT04975061
- Acronym / sponsor ID
- YY-20394-011
- Conditions
- Effectiveness，Safety，Thymic Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Shanghai YingLi Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 23 Jul 2021 (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 study is a single-arm, open, multi-center phase II clinical trial, the main purpose of which is to evaluate the effectiveness and safety of YY-20394 in the treatment of patients with relapsed/refractory thymic cancer.
The research adopts the Simon two-stage design method, which is carried out in two stages.
Detailed description
This study is a single-arm, open, multi-center phase II clinical trial, the main purpose of which is to evaluate the effectiveness and safety of YY-20394 in the treatment of patients with relapsed/refractory thymic cancer.
The research adopts the Simon two-stage design method, which is carried out in two stages.
The first stage:
In the first phase, a single-arm, open, multi-center study was adopted, and YY-20394 monotherapy was given to patients who met the enrollment conditions. The trial enrolled 18 subjects. If ≥2 subjects had ORR (clinical benefit), then enter the second phase, otherwise the trial will be terminated.
The second stage:
Refer to the efficacy data of the first phase to decide whether to conduct the second phase of clinical research.
In the second phase, a single-arm, open, multi-center study was adopted. Patients who met the enrollment conditions were given YY-20394 monotherapy. In the second phase, 40 subjects will continue to be enrolled.
A total of 58 subjects were included in the two stages. During the study period, the investigator judged the best curative effect of all subjects according to the response evaluation criteria in solid tumours (Response evaluation criteria in solid tumours, RECIST 1.1). IRC will use the same standards to evaluate the efficacy of the imaging results of all subjects, and the entire review process will be conducted in accordance with an independent review procedure. The Research Safety Monitoring Committee (SMC) will continue to review the safety of study drugs. SMC will be responsible for monitoring safety data and making decisions on research-related issues, such as study enrollment, dose selection, whether to continue the study, etc.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histologically confirmed thymic cancer (WHO classification), including all subtypes; inoperable advanced disease (Masaoka-Koga staging); progressed after receiving at least one systemic chemotherapy.
Key inclusion criteria (23 listed)
- The age is 18 years old and above;
- Patients with thymic cancer confirmed histologically (WHO classification), including all subtypes;
- Inoperable advanced disease (Masaoka-Koga staging), which progresses after receiving at least one systemic chemotherapy;
- Volunteer to participate in this clinical trial, understand the research procedures and be able to sign written informed consent;
- ECOG performance status (PS) level 0 to 1;
Key exclusion criteria (14 listed)
- Suffer from thymic cancer that can be cured by surgery or radiation;
- Those who have used anti-tumor drugs targeting PI3Kδ have progressed (such as being out of the group due to intolerance) outer);
- Suffer from ongoing malignant tumors or other malignant tumors that require active treatment. Skin base Bottom cell carcinoma, except for squamous cell carcinoma of the skin or cervical cancer in situ after potential treatment;
- Known active central nervous system (CNS) metastasis/cancerous meningitis. Previously accepted Subjects of brain metastasis therapy can participate as long as they are stable (there is no evidence of imaging progress at least 4 weeks before the first dose of trial treatment, and any neurological symptoms have returned to baseline levels), and there are no new or enlarged Evidence of brain metastases in patients, and have not used steroids for at least 7 days before the trial treatment;
- Suffered from active autoimmune disease in the past 3 months and required systemic treatment, or Documented history of clinically severe autoimmune disease, or syndrome requiring systemic steroids or immunosuppressive agents. Except subjects with vitiligo or childhood asthma/atherosclerosis, subjects who need intermittent bronchodilators or topical steroid injections, and subjects with hypothyroidism and stable to hormone replacement or Sjorgen syndrome;
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 |
|---|---|---|
| YY-20394YY-20394 is a small molecule inhibitor. | Drug | – |
Primary outcome
Overall response rate
Time frame: 6 months
Overall response rate consists of complete response and partial response
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Effectiveness，Safety，Thymic Cancer, run by Shanghai YingLi Pharmaceutical Co. Ltd..
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 23 inclusion and 14 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 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: 6 months). 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 23 Jul 2021.