Tarlatamab for Advanced Extrapulmonary Small Cell Carcinoma and Neuroendocrine Carcinoma (TAURUS)

Sponsor
National Taiwan University Hospital
Study ID
NCT06816394
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Extrapulmonary Small Cell Carcinoma and Neuroendocrine Carcinoma

Eligibility Criteria

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

Interventions

  • Tarlatamab — DRUG
    All subjects will receive a step dose (1 mg tarlatamab) on cycle 1 day 1 administered as a 60-minute intravenous (IV) infusion then 10 mg tarlatamab IV administered on cycle 1 day 8, cycle 1 day 15, and every 2 weeks (Q2W) thereafter.

Study Details

Extrapulmonary small cell carcinoma (EPSCC) or neuroendocrine carcinoma (NEC) is a rare but fatal disease. The prognosis of patients with advanced EPSCC or NEC failed platinum-etoposide chemotherapy is poor with median overall survival ranged 6 to 9 months. High expression levels of DLL3 has been demonstrated in many EPSCC or NEC. As tarlatamab, a bispecific T-cell engager with dual affinity for DLL3 on tumor cells and CD3 on T cells, has demonstrated clinically meaningful activity for patients with advanced small cell lung cancer. We thus hypothesize that tarlatamab also has clinically activity for patients with advanced EPSCC and NECs.

Key Dates

Start date
May 15, 2025
Status verified
Feb 2025
Primary completion
Dec 31, 2027
Completion
Apr 30, 2029

Study Design

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

Arms

  • Experimental: Tarlatamab

Primary Outcome Measure

Objective response rate (ORR) per RECIST 1.1 by investigator [ Time Frame: From enrollment to the end of treatment at 8 weeks ]

Central Contacts