Alveolar Soft Part Sarcoma
Conditions
Interventions
Cohort A: Advanced metastatic or unresectable acinar soft tissue sarcoma that has not received prior immunotherapy (stage IV) :Cohort A: IBI110 (200 mg IV Q3W) plus sintilimab (200 mg IV Q3W) was admi
Cohort B: advanced metastatic immunotherapy failure or unresectable acinar soft tissue sarcoma (stage IV) that has failed immunotherapy or unresectable acinar soft tissue sarcoma:Cohort B: IBI110 (200
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Enrollment Criteria: Cohort A: Previously immunotherapy-naïve advanced metastatic or unresectable acinar soft tissue sarcoma (stage IV) 1) Patients with pathologically confirmed advanced metastatic or unresectable acinar soft tissue sarcoma (stage IV) (according to the 8th edition of the American Joint Committee on Cancer [AJCC] stage); 2) have not been treated with T-cell immune checkpoint inhibitors (including but not limited to anti-PD-1/PD-L1 monoclonal antibodies, anti-CTLA-4 monoclonal antibodies); 3) Have not received local therapy for tumor within 4 weeks before the first dose; 4) Whether or not they have received systemic chemotherapy or targeted therapy in the past. Cohort B: Advanced metastatic or unresectable acinar soft tissue sarcoma that has failed immunotherapy (stage IV) 1) Patients with pathologically confirmed advanced metastatic or unresectable acinar soft tissue sarcoma (stage IV) (according to the 8th edition of the American Joint Committee on Cancer [AJCC] stage); 2) Radiographically confirmed disease progression after prior treatment with anti-PD-1/PD-L1 antibodies; 3) Have not received local therapy for the tumor within 4 weeks prior to the first dose. 4) Whether or not they have received systemic chemotherapy or targeted therapy in the past. Enrollment criteria that both Cohort A and Cohort B need to meet: 1) Signed the Informed Consent Form (ICF) and are able to comply with the visits and related procedures specified in the protocol; 2) Male or female >= age 18 years; 3) Expected survival time>= 12 weeks; 4) presence of at least 1 measurable lesion according to RECIST v1.1 criteria, accurately measured by computed tomography (CT) or magnetic resonance imaging (MRI) (intravenous contrast agent preferred) with a length of >=10 mm (except for lymph nodes, which must be =15 mm in the short axis of the lymph node) at baseline, and the lesion is suitable for repeated accurate measurement; 5) Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1; 6) Adequate organ and bone marrow function (except for subjects who have used any cell and growth factor therapy, red blood cell or platelet transfusion, etc. transfusion therapy within 2 weeks prior to the first dose of study drug), defined as follows: Complete blood count: absolute neutrophil count (ANC) >= 1.5×109/L or within the normal range, platelet (PLT) count >=100×109/L, haemo-redHemoglobin (HGB) >= 9.0 g/dL; 7) Liver function: serum total bilirubin (TBIL) =50mL/min, CCr calculated using the Cockcroft-Gault formula (using actual body weight); 9) urine routine: urine protein <2+; for subjects with urine protein =2+ on urine dipstick at baseline, 24-hour urine collection should be performed and the protein content in the urine within 24 hours should be <1g (if both tests are used, the 24-hour urine collection results will be used to determine eligibility); 10) Coagulation function: Activated partial thromboplastin time (APTT) <= 1.5× ULN and International Normalized Ratio (INR) <= 1.5. 11) Female subjects of childbearing age or male subjects whose partner is a woman of childbearing age should use effective contraception throughout the treatment period and for 180 days after the treatment period.
Exclusion criteria
Exclusion criteria: 1. Previous exposure to LAG-3 antibody-based drugs; 2. Received any investigational drug within 4 weeks before the first dose of the study drug; 3. Received systemic chemotherapy or targeted therapy within 28 days before study drug administration; 4. Received systemic treatment with Chinese herbal medicine or immunomodulatory drugs (including thymosin, interferon, interleukin) with anti-tumor indications within 2 weeks before the first dose; 5. Participating in another interventional clinical study or in the follow-up stage of an interventional study; 6. Known Central Nervous System (CNS) metastasis and/or spinal cord compression and/or carcinommeningitis, with a history of leptomeningeal carcinomatosis. Patients who were symptomatic and stable after radiation or surgery for brain metastases were eligible to participate in the study if they met all the following criteria: measurable disease outside the central nervous system; There was no mesencephalon, pons, meninges, medulla oblongata or spinal cord metastasis. Participants were eligible if they had no evidence of new or expanding brain metastases after treatment for brain metastases and if they had stopped corticosteroid and anticonvulsant therapy for at least 14 days prior to study treatment; Patients with asymptomatic brain metastases who met the above conditions after treatment were eligible for inclusion in the study. 7. Other malignant tumors diagnosed within 5 years before the first dose of treatment, excluding the following: radical skin basal cell carcinoma, skin squamous cell carcinoma and/or carcinoma in situ after radical resection, local prostate cancer, papillary thyroid cancer after radical resection, etc.; 8. Is expected to receive other antineoplastic therapy during the trial treatment; 9. Need long-term systemic hormone or any other immunosuppressive drug therapy, excluding inhaled hormone therapy; 10. Use of immunosuppressive drugs within 4 weeks before the first dose of study drug, excluding: (1) intranasal topical steroid therapy or local steroid injection (e.g., intra-articular injection); (2) no systemic corticosteroid therapy exceeding 10mg/ day of prednisone or its physiological equivalent; (3) glucocorticoids as a preventive drug for allergic reactions (e.g., before CT). 11. Receive live attenuated vaccine less than 4 weeks before the first dose of study drug or is planned to do so during the study; 12. Had undergone major surgical procedures (craniotomy, thoracotomy, laparotomy, or other investigator-defined) or had nonhealed wounds, ulcers, or fractures within 4 weeks before the first dose of study drug. Note: For the purpose of palliative treatment, local surgery is acceptable for isolated lesions. 13. A history of radiation pneumonitis, idiopathic pneumonitis, active pneumonitis, pulmonary fibrosis, diffuse interstitial lung disease, or organizing pneumonia (e.g., bronchiolitis obliterans); 14. Have an active autoimmune or inflammatory disease (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [other than diverticulosis], celiac disease, systemic lupus erythematosus, Sarcoidosis syndrome or Wegener syndrome [granulomatosis with polyangiitis], Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.), or a history of the disease within the previous 2 years (vitiligo, psoriasis, alopecia, or Graves' disease that did not require systemic treatment within the previous 2 years; Subjects with hypothyroidism requir
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS;Disease control rate, DCR;Duration of remission, DoR;Time to remission, TTR; | — |
Countries
China
Contacts
Public ContactJiayong Liu
Beijing Cancer Hospital
Outcome results
None listed