Milaberon in Advanced Solid Tumors: an Open, Multicenter Clinical Study

Cohort A non-small cell lung cancer (NSCLC): A1 non-squamous cell carcinoma, Sintilimab or tislelizumab(3 mg/kg) pemetrexed(500mg/m2) cisplatin(75mg/m2) or carboplatin (AUC 5) q3w, 4-6 cycles of induction chemotherapy, Sintilimab or tislelizumab + pemetrexed maintenance, q3w; A2 squamous cell carcinoma, Sintilimab or tislelizumab(3 mg/kg) nab-paclitaxel (100mg/m2 d1/8/15) carboplatin (AUC 5) q3w,4-6 cycles, Sintilimab or tislelizumab maintenance, q3w; Cohort B Small cell lung cancer (SCLC) Serplulimab (4.5 mg/kg, D1) Carboplatin (AUC 5,D1) Etoposide (100 mg/m 2, D1-3),q3w, Cycle 4-6, Serplulimab maintained q3w Cohort C Colorectal cancer XELOX + bevacizumab (7.5 mg/kg,D1),q3w,8 cycles, bevacizumab + capecitabine maintenance, q3w; XELOX: oxaliplatin(130mg/m2 intravenous infusion\> 2h D1), capecitabine (1000mg/m2 oral bid,D1-14),q3w; If the primary tumor is in the left colon or rectum, RAS/BRAF is wild type, cetuximab (500mg/m2,D1) + mFOLFOX6 is also admitted. mFOLFOX6: oxaliplatin(85mg/m2, intravenous infusion 2h,D1) LV(400mg/m2, intravenous infusion 2h,D1) 5-FU (400mg, intravenous push, D1, then 1200mg/(m2 \* d)X2 days continuous intravenous infusion), 12 cycles, bevacizumab + capecitabine maintenance, q3w Cohort D Pancreatic cancer GEM + nab-paclitaxel regimen, GEM(1000mg/m2) nab-paclitaxel(125mg/m2) ,D1,8, 15,q4w,6-8 cycles Adjustable GEM + nab-paclitaxel regimen, GEM(1000mg/m2) nab-paclitaxel(125mg/m2) ,D1, 8,q3w,6-8 cycles Cohort E Triple-Negative Breast Cancer TX regimen: docetaxel(75mg/m2 D1),q3w or nab-paclitaxel(100-150mg/m2 D1,qw),capecitabine(1000mg/m2 oral bid,D1-14),q3w,6-8 cycles; capecitabine maintenance, q3w (taxmen treatment sensitive) GP regimen: GEM(1000mg/m2 ,D1, 8) cisplatin(75mg/m2 ,divided into D1-3) q3w (taxane treatment failure) Cohort F Diffuse large B- cell lymphoma R-CHOP 6 cycles then R 2 cycles; R-CHOP: rituximab(375mg/m2,D0) cyclophosphamide(750mg/m2 D1),doxorubicin(40-50mg/m2,D1) vincristine(1.4mg/m2 D1 ,maximum dose 2mg) prednisone(100mg,D1-5 mg), q3w Cohort G Head and neck squamous cell carcinoma G1 Recurrent/metastatic squamous cell carcinoma of head and neck (non-nasopharyngeal carcinoma) PF: Cisplatin(100mg/m2 D1) or Carboplatin(AUC 5 D1), 5-Fu(1000mg/m2 d1-4),q3w TP: paclitaxel(175mg/m2 D1) cisplatin (75mg/m2 d1), q3w G2 Recurrent/Metastatic Nasopharyngeal Squamous Cell Carcinoma GP+Camrelizumab or Tislelizumab: cisplatin(80mg/m2 d1) gemcitabine (1000mg/m2 d1,8), then camrelizumab or tislelizumab 200mg,q3w maintenance