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

Sponsor
Inkeun Park
Study ID
NCT06893783
Phase
PHASE2
Status
Recruiting
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Conditions

  • Neuroendocrine Carcinoma of Pancreas
  • Neuroendocrine Carcinoma of Prostate
  • Neuroendocrine Carcinomas (NEC)

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tarlatamab — DRUG
    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

Study Details

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.

Key Dates

Start date
Sep 2, 2025
Status verified
Apr 2026
Primary completion
Apr 30, 2029
Completion
Apr 30, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: All patient
    The study will be divided into a gastrointestinal and pancreatic-biliary cohort and a genitourinary cohort; however, the dosage, frequency, duration, and administration route of the investigational drug will remain the same as outlined below. Tarlatamab 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

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: 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 ]

Central Contacts

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