Tarlatamab in Advanced Delta-like 3 (DLL3)-Expressing Tumors Including Neuroendocrine Neoplasms (NCT06788938) | Clinical Trial Compass
RecruitingPhase 2
Tarlatamab in Advanced Delta-like 3 (DLL3)-Expressing Tumors Including Neuroendocrine Neoplasms
United States29 participantsStarted 2025-03-21
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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:
✓. Positive DLL3 expression by immunohistochemistry on tumor biopsy.
✓. 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
Exclusion criteria
What they're measuring
1
1. Primary efficacy endpoint is overall response rate (ORR) as defined as complete response (CR) or partial response (PR) by RECIST 1.1 criteria. This is evaluated in the response evaluable set of patients.
✕. Diagnosis of SCLC (with the exception of SCLC transformed from previously-treated NSCLC) or NEPC.
✕. Tumor specimen is not evaluable for DLL3 expression or tumor has DLL3 surface expression \< 1% by immunohistochemistry.
✕. Progressive or symptomatic brain metastases. Brain metastases that have been radiated, are asymptomatic, and on a stable or decreasing dose of steroids are allowed. Leptomeningeal disease is excluded.
✕. Evidence of interstitial lung disease or active, non-infectious pneumonitis. Exception: pneumonitis related to prior radiation therapy that is grade 1 and stable or improving without treatment.
✕. Concurrent enrollment in another clinical study, unless enrolled only in the follow-up period or an observational study. Use of any investigational anticancer therapy must not have been received within 28 days prior to the first dose of study drugs.
✕. Any chemotherapy, antibody drug conjugate or immunotherapy for cancer treatment in the prior 21 days, or small molecular inhibitor in the prior 7 days.
✕. Prior therapy with any selective inhibitor of the DLL3 pathway.
✕. Prior history of severe or life-threatening events from any immune-mediated therapy.