A Phase 2 Clinical Study of YY-20394 in Patients With Relapsed/Refractory Thymic Cancer

NCT04975061 | Unknown DMC

• 1 other identifier: YY-20394-011
• Study Type: observational
• Target: 58
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Effectiveness，Safety，Thymic Cancer

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  Overall response rate consists of complete response and partial response

  6 months

Interventions

YY-20394 DRUG

YY-20394 is a small molecule inhibitor.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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;
• 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;

You may not qualify if:

• 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.);
• 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

Sponsors & Collaborators

• Shanghai YingLi Pharmaceutical Co. Ltd.: lead

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 23, 2021
• Study Start: August 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 30, 2022
• Last Updated: July 23, 2021

Record last verified: 2021-07