Safety and Clinical Activity of Nivatrotamab in Relapsed/Recurrent Metastatic Small-cell Lung Cancer

Inclusion Criteria

• •Signed and dated informed consent has been provided prior to any trial-related procedures.
• •Patient willing and able to comply with the trial protocol
• •Age ≥18 years at the time of informed consent
• •Histologically or cytologically proven SCLC. Radiographical relapse/progression after minimum 1 line of platinum-containing chemotherapy with partial response or complete response as the best response (only applicable for phase 2) and not more than 3 prior lines of therapy
• •Measurable disease according to RECIST v1.1
• •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• •Expected survival \>3 months
• •Platelet counts ≥100,000 cells/mm3
• •Hemoglobin ≥9 g/dL
• •Absolute neutrophil count (ANC) ≥1000 cells/mm3
• •Adequate liver function defined by aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) ≤3 × upper limit of normal (ULN), and serum bilirubin ≤1.5 × ULN with the following exceptions
• •In patients with documented liver metastases, AST, ALT, and ALP ≤5 × ULN and serum bilirubin ≤1.5 × ULN
• •Adequate renal function with serum creatinine ≤1.5 mg/dL or creatinine clearance ≥50 mL/min as calculated using the Cockcroft Gault equation
• •Serum albumin \>3.0 g/dL
• •Women of child-bearing potential must agree to appropriate contraception during treatment and for a period of 30 days after the last dose of study drug.
• •Furthermore, patients are excluded if they have:
• •Patients who experienced severe or recurrent (\>grade 2) immune mediated adverse events (AEs) or infusion related reactions (IRRs), including those that lead to permanent discontinuation while on treatment with immune oncology agents
• •Prior treatment with anti-GD2 antibody or bispecific antibodies
• •Patients with Limited Disease (LD), who are candidates for local or regional therapy.
• •Impending need for palliative radiotherapy or surgery for pathological fractures and/or for medullary compression up to 3 weeks prior to the first planned dosing of the IMP per protocol (palliative radiation for other reasons within 2 weeks)
• •History of other active malignancy within the past 3 years prior to the first planned dosing of the IMP per protocol (excluding non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, incidental prostate cancer (T1a, Gleason score ≤ 6, prostate specific antigen (PSA) less than 0.5 ng/ml)