Alveolar Soft Part Sarcoma
Conditions
Interventions
Group A:IBI363: priming dose: 100µg/kg (C0), from C1D1: 3mg/kg,Q3W,Intravenous infusion
Group B:IBI363: priming dose: 100µg/kg (C0), from C1D1: 3mg/kg,Q3W,Intravenous infusion
Sponsors
Peking University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Cohort A: Advanced Metastatic or Unresectable Alveolar Soft Part Sarcoma (Stage IV) Not Previously Treated with Immunotherapy 1. Patients with pathologically confirmed advanced metastatic or unresectable alveolar soft part sarcoma (Stage IV) (according to the 8th edition of the American Joint Committee on Cancer [AJCC] staging system). 2. Patients who have not received T-cell immune checkpoint inhibitors (including but not limited to anti-PD-1/PD-L1 monoclonal antibodies, anti-CTLA-4 monoclonal antibodies). 3. Patients who have not received any local treatment targeting the tumor within 4 weeks prior to the first dose. 4. Patients may or may not have received prior systemic chemotherapy or targeted therapy. Cohort B: Advanced Metastatic or Unresectable Alveolar Soft Part Sarcoma (Stage IV) with Failed Immunotherapy 1. Patients with pathologically confirmed advanced metastatic or unresectable alveolar soft part sarcoma (Stage IV) (according to the 8th edition of the American Joint Committee on Cancer [AJCC] staging system). 2. Patients who have experienced radiographically confirmed disease progression following treatment with anti-PD-1/PD-L1 antibodies. 3. Patients who have not received any local treatment targeting the tumor within 4 weeks prior to the first dose. 4. Patients may or may not have received prior systemic chemotherapy or targeted therapy. Inclusion Criteria for Both Cohort A and Cohort B: 1. Signed written informed consent and the ability to comply with the protocol's visit schedule and related procedures. 2. Age = 18 years, with no gender restrictions. 3. At least one measurable lesion according to RECIST v1.1 (solid tumors), with a minimum length of 10mm as measured by CT or MRI (with contrast preferred), excluding lymph nodes. The short axis of lymph nodes must be = 15mm. Lesions in previously irradiated areas can be considered target lesions if progression is clearly documented. 4. Baseline complete blood count (within 7 days before the first dose) meeting the following criteria: - Hemoglobin = 90 g/L - Absolute neutrophil count (ANC) = 1.5 × 10^9/L - Platelet count = 100 × 10^9/L *Baseline is defined as the last available value before the first administration of the study drug. Subjects must not have received blood product transfusions, erythropoiesis-stimulating agents, or colony-stimulating factors within 7 days before sample collection. 5. Baseline serum biochemistry (within 7 days before the first dose) meeting the following criteria: - Total bilirubin = 1.5 × the upper limit of normal (ULN) (subjects with total bilirubin > 1.5 × ULN but direct bilirubin = ULN are eligible) - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) = 3 × ULN (= 5 × ULN if liver metastases are present) - Serum creatinine = 1.5 × ULN or creatinine clearance (CCr) = 45 mL/min, calculated using the Cockcroft-Gault formula (Appendix 3) - Albumin = 30 g/L 6. Baseline coagulation tests (within 7 days before the first dose) meeting the following criteria: - International normalized ratio (INR) = 1.5 × ULN (= 3 × ULN for subjects on stable anticoagulant therapy) - Partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) = 1.5 × ULN (= 3 × ULN for subjects on stable anticoagulant therapy) 7. Baseline urinalysis (within 7 days before the first dose) meeting the following criteria: - Urine protein < 2+. Subjects with = 2+ proteinuria on dipstick test must have
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. Women who are pregnant, breastfeeding, or planning to become pregnant before, during, or within 6 months after the study drug administration. 2. History of seizures, active central nervous system (CNS) metastasis, spinal cord compression, carcinomatous meningitis, or leptomeningeal metastasis. - Patients who have received treatment for CNS metastases must meet the following criteria to participate in the study: completion of CNS metastasis treatment (e.g., whole-brain radiotherapy, stereotactic radiotherapy, or equivalent treatment) =14 days before the first dose of the study drug; no new brain metastases or enlargement of existing brain metastases confirmed by repeat imaging after CNS metastasis treatment (interval =4 weeks between imaging before treatment and after treatment using the same imaging techniques); no requirement for steroid treatment and stable symptoms =14 days before the first dose. - Patients with untreated CNS metastases must meet the following criteria: no CNS metastasis-related symptoms; no immediate need for CNS metastasis treatment as evaluated by the investigator. 3. Clinically significant cardiovascular or cerebrovascular disease, including: - Requiring medical intervention for ventricular arrhythmias or other uncontrolled arrhythmias, such as antiarrhythmic drugs; - Severe conduction disorders (e.g., third-degree atrioventricular block); - Corrected QT interval (QTc, using Fridericia's formula) = 480 ms; - Uncontrolled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >90 mmHg), history of hypertensive crisis or hypertensive encephalopathy; - History of myocarditis; - Symptomatic congestive heart failure (NYHA Class II-IV) or left ventricular ejection fraction (LVEF) < 50% on echocardiography; - Any arterial thrombosis, embolism, or ischemia within 6 months prior to the first dose, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack; - Deep vein thrombosis or any severe thromboembolism within 3 months prior to enrollment (implantable venous access port or catheter-related thrombosis, or superficial venous thrombosis are not considered "severe" thromboembolism); - Known active seizures. 4. History of interstitial lung disease, pulmonary fibrosis, or other restrictive lung diseases. 5. History of allergies, asthma, or atopic dermatitis. 6. Presence of significant pleural or peritoneal effusion or pericardial effusion requiring repeated drainage or with obvious symptoms (patients who do not require drainage or whose effusion does not significantly increase after stopping drainage for 3 days can be enrolled). 7. History of active autoimmune diseases requiring systemic treatment (such as disease-modifying agents, corticosteroids, or immunosuppressive agents) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic treatment. 8. History of allogeneic organ or allogeneic hematopoietic stem cell transplantation. 9. Known or suspected allergy to the study drug or any of its excipients. 10. Significant toxicity history associated with immune checkpoint inhibitors or the study drug requiring permanent discontinuation of the treatment. 11. Unresolved = Grade 1 toxicity (excluding persistent Grade 2 alopecia, hemoglobin reduction, or hypomagnesemia) related to p
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event (AE), including treatment-related AEs (TRAE), immune-related AEs (irAEs);duration of response; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate;progression-free survival;overall survival;time to response;overall response rate; | — |
Countries
China
Contacts
Public ContactLIU Jiayong
Peking University Cancer Hospital
Outcome results
None listed