Study of Benralizumab in People with Skin Side Effects Caused by Cancer Therapies

Inclusion Criteria

• Patients must have pathologically or cytologically confirmed solid or hematologic cancers OR patient is receiving alpelisib for PIK3CA-Related Overgrowth Spectrum disorder
• Female and male aged 18 to 85 years, inclusively, at the time of Week 0/Day 1 of treatment
• Patients must have a therapy-related CTCAE grade 2/3 cutaneous adverse event defined as any cutaneous reaction listed below and blood eosinophil counts of at least .3 K/mcl * Rash maculo-papular * Bullous dermatitis * Pruritus * Urticaria * Eczema
• Patients must plan to continue on culprit drugs (cancer patients)
• Patients planning to receive alpelisib indicated for PIK3CA-related overgrowth spectrum disorder OR patients receiving immunotherapy and/or targeted therapy, including but not limited to the following agents, will be eligible for inclusion: * Immunotherapies: ipilimumab, nivolumab, pembrolizumab, avelumab, durvalumab, atezolizumab tremelimumab * Targeted therapies: trastuzumab, pertuzumab, alpelisib, osimertinib, everolimus, temsirolimus, sorafenib, regorafenib
• Patients using topicals/orals for indication of skin rash/pruritus for at least 7 days should continue using these drugs for the study duration
• Total bilirubin =< 1.5 x the upper limit of normal (ULN)
• Alanine aminotransferase (ALT) and aspartate amino-transferase (AST) =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer)
• Alkaline phosphatase =< 2.5 x ULN (=< 5 x ULN for subjects with liver involvement of their cancer)
• Serum creatinine =< 1.8 x ULN or calculated creatinine clearance > 45 ml/min
• Platelet count > 50 K/mcL (blood transfusion to meet the inclusion criteria will not be allowed)
• Hemoglobin (Hb) > 8 g/dL (blood transfusion to meet the inclusion criteria will not be allowed)
• Absolute neutrophil count (ANC) > 1.0 K/mcL (blood transfusion to meet the inclusion criteria will not be allowed)
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Subjects must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure
• Female patients are authorized to participate if they meet the following criteria: * Women of child bearing potential must meet both of the following conditions: ** Have a negative serum pregnancy test prior to enrollment and within 14 days prior to administration of the investigational product (IP) ** Patient must use an effective form of birth control (confirmed by the Investigator) throughout the study duration and within 16 weeks after last dose of IP * Female subjects who cannot bear children as evidenced by one or more of the following: ** Bilateral Oophorectomy ** Bilateral Salpingectomy ** Bilateral Salpingectomy-Oophorectomy ** Hysterectomy ** Menopause (no menses >= 1 year prior to treatment) ** Surgical Sterilization (i.e., tubal ligation or blockage) *** Note: If criteria not met, patient should be regarded as having child bearing potential
• Subject must be able to receive a subcutaneous injection
• New/worsening ercAE within 90 days prior to study enrollment. Note: this assessment will be performed by the treating investigator

Exclusion Criteria

• Concurrent use of another investigational drug or device for the ercAE (i.e., outside of study treatment) during, or within 4 weeks of treatment
• Patients receiving prednisone >= 20 mg a day
• Known use of anti-IL-5 agents or biologics for the treatment of asthma which are known to decrease blood eosinophil levels
• Patients cannot use new topicals or medications for indication of pruritus or skin rash
• Known history of anaphylaxis to biologic therapy
• A helminthic parasitic infection diagnosed within 24 weeks prior to the first treatment, that had not been treated with, or has failed to respond to, standard of care therapy
• Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy
• Active infection that would impair the ability of the patient to receive study treatment
• Women who are pregnant or breast-feeding
• Any condition which, in the investigator’s opinion, makes the subject unsuitable for trial participation
• Receipt of live attenuated vaccines 30 days prior to the date of randomization * Receipt of inactive/killed vaccinations (e.g., inactive influenza) is allowed provided they were not administered within 1 week before/after any investigational product administration
• Known history of allergy or reaction to the investigational product formulation