Tarlatamab in Advanced Delta-like 3 (DLL3)-Expressing Tumors Including Neuroendocrine Neoplasms

Recruiting now · Phase 2

Conditions studied: DLL3-expressing Tumors, Advanced Tumors

In brief

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.

Key facts

Study ID

NCT06788938

Run by

Jonsson Comprehensive Cancer Center

People needed

29

Starts

2025-03-21

Expected to finish

2029-04-24

Last updated by the study team

2026-05-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Disease Related
• 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.
• Prior/Concomitant Therapy
• 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.
• Stereotactic, palliative radiation for symptomatic bone metastases is acceptable without a washout.
• Stereotactic brain radiation for asymptomatic brain metastases is acceptable with a 7-day washout.
• Prior therapy with any selective inhibitor of the DLL3 pathway.
• Prior history of severe or life-threatening events from any immune-mediated therapy.
• Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days prior to enrollment. Low-dose corticosteroids (prednisone ≤ 10 mg per day or equivalent is permitted)
• Major surgical procedures within 28 days prior to first dose of study treatment.
• Treatment with live virus, including live-attenuated vaccination, within 14 days prior to the first dose of study treatment. Inactive vaccines (e.g., non-live or non-replicating agent) and live viral non-replicating vaccines within 3 days prior to first dose of study treatment.
• Other Medical Conditions
• History of other malignancy within the past 2 years, with the following exceptions:
• Malignancy treated with curative intent before enrollment, with no known active disease and felt to be at low risk for recurrence by the treating physician, after discussion with the medical monitor.
• Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
• Adequately treated cervical carcinoma in situ without evidence of disease.
• Adequately treated breast ductal carcinoma in situ without evidence of disease.
• Prostatic intraepithelial neoplasia without evidence of prostate cancer.
• Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ.
• History of myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association, class II) within 6 months prior to first dose of study treatment.
• History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 6 months prior to first dose of study treatment.

Where it is running

• UC Davis Comprehensive Cancer Center — Davis, California, United States (enrolling)
• UCI Health Chao Family Comprehensive Cancer Center — Irvine, California, United States (enrolling)
• University of California at Los Angeles — Los Angeles, California, United States (enrolling)
• UC San Diego Moores Cancer Center — San Diego, California, United States (enrolling)
• University of California at San Francisco — San Francisco, California, United States (enrolling)

Full record on ClinicalTrials.gov

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