Efficacy and Safety Evaluation of Tarlatamab in Advanced Extrapulmonary Neuroendocrine Carcinoma … (NCT06893783) | Clinical Trial Compass
RecruitingPhase 2
Efficacy and Safety Evaluation of Tarlatamab in Advanced Extrapulmonary Neuroendocrine Carcinoma Patients
South Korea60 participantsStarted 2025-09-02
Plain-language 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.
Who can participate
Age range19 Years
SexALL
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Inclusion Criteria:
\- Subject has provided informed consent prior to initiation of any study specific activities/procedures.
* Age ≥19 years at the time of signing the informed consent.
* Histologically confirmed relapsed/refractory extra-pulmonary neuroendocrine carcinoma. Neuroendocrine carcinoma includes small cell carcinoma, large cell carcinoma, and mixed histology of neuroendocrine and other histology (e.g., adenoneuroendocrine carcinoma, urothelial carcinoma with neuroendocrine component). In patients with prostate cancer, treatment-emergent neuroendocrine carcinoma (initially adenocarcinoma, but transdifferentiate into neuroendocrine carcinoma after androgen deprivation therapy) will be permitted.
* Cohort 1 (gastrointestinal and pancreaticobiliary cohort): cancers originated from stomach, esophagus, small intestine, colorectal, pancreas, or bile ducts.
* Cohort 2 (genitourinary cohort): cancers originated from prostate, bladder, ureter, urethra, or kidney.
* Subject has progressed or recurred following 1 platinum-based regimen:
* documented first disease progression must be during or following first-line platinum-based systemic chemotherapy. For patients with prostate cancer, especially in cases with treatment-emergent neuroendocrine carcinoma, platinum-based chemotherapy will not need to be the first line therapy.
* patients who received treatment for localized disease who recur are eligible
* patients who received adjuvant Platinum-Etoposide (EP) after rese…
What they're measuring
1
Objective response rate (ORR)
Timeframe: From the date of first dose until the date of the first confirmed objective response (PR or CR) per RECIST v1.1, assessed up to 36 months