Tarlatamab in Advanced DLL3-Expressing Tumors Including Neuroendocrine Neoplasms
This study is being done to learn more about the drug tarlatamab in people with your condition. The purpose of this study is to see the efficacy (how well something works) of study treatment (tarlatamab) and whether it causes any side effects. Tarlatamab is being developed as an anti-cancer drug for tumors and is FDA-approved for extensive-stage small cell lung cancer. Tarlatamab is investigational for the purpose of this study.
∙ Participants are eligible to be included in the study only if all of the following criteria apply:
• Participant has provided informed consent prior to initiation of any study specific activities/procedures.
• Male or female ≥ 18 years of age and willing and able to provide informed consent.
• Histologically or cytologically confirmed malignancy other than de novo (i.e., non-transformed) SCLC or NEPC. Must be stage IV (metastatic); participants with stage III disease are eligible provided that they are not candidates for surgery and/or radiotherapy with curative intent. Acceptable tumor types include the following:
‣ Low and intermediate grade neuroendocrine carcinoma (including carcinoid and atypical carcinoid)
⁃ Gastroenteropancreatic NEN
⁃ Large cell neuroendocrine carcinoma
⁃ SCLC transformed from previously-treated NSCLC
⁃ Extrapulmonary small cell carcinoma, with the exception of NEPC
⁃ Any other tumor type that meets staging and DLL3 positivity criteria
• Positive DLL3 expression by immunohistochemistry on tumor biopsy.
• • Positive DLL3 expression, for purposes of this study, defined as at least 25% for participants enrolling into Stage 1 or 1% for participants enrolling into Stage 2.
• Participants must have progressed on or following at least one line of therapy, if a standard of care therapy exists for the tumor type.
• Measurable disease, as per RECIST 1.1
• ECOG performance status of 0-1.
• Adequate organ function as defined in Table 3 below. System Laboratory Value Hematological Absolute neutrophil count (ANC) ≥ 1.0 x 109/L Platelets ≥ 100 x 109/L Hemoglobin ≥ 9 g/dL Renal Estimated glomerular filtration rate (eGFR) based on Modification of Diet in Renal Disease (MDRD) ≥ 30 mL/min/1.73 m2 Hepatic Serum total bilirubin ≤ 1.5 x ULN, with the exception of participants with Gilbert's disease AST (SGOT) and ALT (SGPT) ≤ 3 x ULN≤ 5 x ULN for patients with liver metastasis or primary liver cancer Coagulation International Normalized Ratio (INR) or Prothrombin Time (PT), and Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy, and then only as long as PT or PTT is within therapeutic range of intended use of anticoagulants