RecruitingPhase 2NCT06893783

Efficacy and Safety Evaluation of Tarlatamab in Advanced Extrapulmonary Neuroendocrine Carcinoma Patients

A Phase II Trial of Tarlatamab, a DLL3-targeted Bispecific T-cell Engager, in Patients With Advanced Extrapulmonary Neuroendocrine Carcinoma (DeLLight)


Sponsor

Inkeun Park

Enrollment

60 participants

Start Date

Sep 2, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase 2 single-arm, open-label clinical trial designed to evaluate the efficacy and safety of tarlatamab in patients with relapsed extrapulmonary neuroendocrine carcinoma (EPNEC) who have previously received platinum-based first-line chemotherapy. Participants will receive tarlatamab on Cycle 1 Day 1 (C1D1), Day 8 (C1D8), and Day 15 (C1D15), followed by administration every two weeks thereafter. No placebo control is included in this study.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called tarlatamab — an immunotherapy that helps the immune system attack cancer cells — in people with an aggressive, rare form of cancer called extra-pulmonary neuroendocrine carcinoma (a neuroendocrine cancer that starts outside the lungs) whose cancer has returned or has not responded to previous treatment. **You may be eligible if...** - You are 19 or older - You have been confirmed by biopsy to have relapsed or treatment-resistant extra-pulmonary neuroendocrine carcinoma (cancers such as small cell or large cell neuroendocrine carcinoma originating from the gut, pancreas, prostate, or other sites) - You have received prior treatment that did not work **You may NOT be eligible if...** - Your cancer originated in the lungs (this trial is specifically for cancers outside the lungs) - You have not yet tried other standard treatments - You have health conditions that make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTarlatamab

1 mg step dose on cycle 1 day 1 10 mg target dose starting cycle 1 day 8, cycle 1 day 15, and every 2weeks thereafter


Locations(4)

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Yonsei Severance Hospital

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT06893783