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- Essai clinique NCT04975061
A Phase 2 Clinical Study of YY-20394 in Patients With Relapsed/Refractory Thymic Cancer
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- 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;
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.
Exclusion Criteria:
- 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Overall response rate
Délai: 6 months
|
Overall response rate consists of complete response and partial response
|
6 months
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- YY-20394-011
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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Essais cliniques sur YY-20394
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Shanghai YingLi Pharmaceutical Co. Ltd.Pas encore de recrutement
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Shanghai YingLi Pharmaceutical Co. Ltd.InconnueUne étude de phase Ib de YY-20394 chez des participants atteints d'hémopathies malignes à cellules BLymphome à cellules du manteau | Lymphome de la zone marginale | Lymphome lymphoplasmocytaire | Lymphome diffus à grandes cellules B | Petit lymphome lymphocytaire
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Shanghai YingLi Pharmaceutical Co. Ltd.InconnueLymphome T périphérique récidivant ou réfractaireChine
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Shanghai YingLi Pharmaceutical Co. Ltd.Inconnue
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Shanghai YingLi Pharmaceutical Co. Ltd.Pas encore de recrutement
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Ruijin HospitalTianjin Medical University Cancer Institute and HospitalPas encore de recrutementFocus sur le lymphome, y compris le lymphome à cellules B/TChine
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Shanghai YingLi Pharmaceutical Co. Ltd.RecrutementLymphome périphérique à cellules T/NK (R/R PTCL)États-Unis
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University of CopenhagenEC-FP6 (contract number: LHM-CT-2003-503041); Aditech Pharma ABComplété
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University of CopenhagenAditech Pharma ABComplété
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Gila Therapeutics, Inc.ComplétéTroubles de l'alimentation et de l'alimentationÉtats-Unis