Combination therapy using a liv1-adc and a chemotherapeutic

Abstract

The invention provides methods of treating a subject having or at risk of cancer by administering a LIV-1 antibody drug conjugate and a chemotherapeutic.

1 . A method for treating a subject having cancer, the method comprising administering to the subject a LIV-1 antibody drug conjugate (LIV-1-ADC) and a chemotherapeutic, wherein the LIV-1-ADC comprises a humanized hLIV22 antibody conjugated to a vcMMAE (valine-citrulline-monomethyl auristatin E), and wherein the chemotherapeutic is one of carboplatin, doxorubicin, and paclitaxel. 
     
     
         2 . The method of  claim 1 , wherein the subject has breast cancer. 
     
     
         3 . The method of  claim 2 , wherein the breast cancer is triple negative breast cancer, triple positive breast cancer, HER2-positive breast cancer, or hormone receptor positive cancer. 
     
     
         4 . The method of  claim 3 , wherein the subject has triple negative breast cancer. 
     
     
         5 . The method of  claim 1 , wherein the subject has prostate cancer, ovarian cancer, endrometrial cancer, pancreatic cancer, lung cancer, a cervical cancer, a melanoma, or squamous cell carcinoma. 
     
     
         6 . The method of  claim 1 , wherein the LIV-1-ADC is administered at a dosage between 1.5 mg/kg and 4 mg/kg of the subject's body weight. 
     
     
         7 . The method of  claim 1 , wherein the LIV-1-ADC is administered at a dosage of 2.5 mg/kg of the subject's body weight. 
     
     
         8 . The method of  claim 1 , wherein the LIV-1-ADC is administered once every 3 weeks. 
     
     
         9 . The method of  claim 1 , wherein the LIV-1-ADC is administered by intravenous injection. 
     
     
         10 . The method of  claim 1 , wherein the chemotherapeutic is carboplatin, and wherein the carboplatin is administered at a dosage between 200 mg/m 2  and 750 mg/m 2 . 
     
     
         11 . The method of  claim 1 , wherein the chemotherapeutic is carboplatin, and wherein the carboplatin is administered by intravenous injection. 
     
     
         12 . The method of  claim 1 , wherein the chemotherapeutic is doxorubicin, and wherein the doxorubicin is administered at a dosage between 40 mg/m 2  and 80 mg/m 2 . 
     
     
         13 . The method of  claim 1 , wherein the chemotherapeutic is doxorubicin, and wherein the doxorubicin is administered by intravenous injection. 
     
     
         14 . The method of  claim 1 , wherein the chemotherapeutic is paclitaxel, and wherein the paclitaxel is administered at a dosage between 100 mg/m 2  to 260 mg/m 2 . 
     
     
         15 . The method of  claim 1 , wherein the chemotherapeutic is paclitaxel, and wherein the paclitaxel is administered by intravenous injection. 
     
     
         16 . A method for treating a subject having cancer, the method comprising administering to the subject a combination of carboplatin and a LIV-1 antibody drug conjugate (LIV-1-ADC), wherein the LIV-1-ADC comprises a humanized hLIV22 antibody conjugated to a vcMMAE (valine-citrulline-monomethyl auristatin E), wherein the LIV-1-ADC is administered to the subject intravenously once every three weeks at a dosage of 2.5 mg/kg of the subject's body weight, and wherein the carboplatin is administered at a dosage of 300 mg/m 2 . 
     
     
         17 . A method for treating a subject having cancer, the method comprising administering to the subject a combination of doxorubicin and a LIV-1 antibody drug conjugate (LIV-1-ADC), wherein the LIV-1-ADC comprises a humanized hLIV22 antibody conjugated to a vcMMAE (valine-citrulline-monomethyl auristatin E), wherein the LIV-1-ADC is administered to the subject intravenously once every three weeks at a dosage of 2.5 mg/kg of the subject's body weight, and wherein the doxorubicin is administered at a dosage of 60 mg/m 2 . 
     
     
         18 . A method for treating a subject having cancer, the method comprising administering to the subject a combination of paclitaxel and a LIV-1 antibody drug conjugate (LIV-1-ADC), wherein the LIV-1-ADC comprises a humanized hLIV22 antibody conjugated to a vcMMAE (valine-citrulline-monomethyl auristatin E), wherein the LIV-1-ADC is administered to the subject intravenously once every three weeks at a dosage of 2.5 mg/kg of the subject's body weight, and wherein the paclitaxel is administered at a dosage of 175 mg/m 2 . 
     
     
         19 . A method for treating a subject having triple negative breast cancer, the method comprising administering to the subject a LIV-1 antibody drug conjugate (LIV-1-ADC) and a chemotherapeutic, wherein the LIV-1-ADC comprises a humanized hLIV22 antibody conjugated to a vcMMAE (valine-citrulline-monomethyl auristatin E), and wherein the chemotherapeutic is one of carboplatin, doxorubicin, and paclitaxel. 
     
     
         20 - 30 . (canceled)