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

NCT06816394 | Not Yet Recruiting Phase 2

• 2 other identifiers: 202412002MIFE20247089
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Extrapulmonary Small Cell Carcinoma and Neuroendocrine Carcinoma

Keywords

tarlatamab; extrapulmonary small cell carcinoma; neuroendocrine carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR) per RECIST 1.1 by investigator

  From enrollment to the end of treatment at 8 weeks

Study Arms (1)

Tarlatamab

EXPERIMENTAL

Drug: Tarlatamab

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.

Tarlatamab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent.
• Failed prior platinum-based chemotherapy
• Histologically proven extrapulmonary small cell carcinoma or neuroendocrine carcinoma from gastrointestinal tract, genitourinary tract, gynecologic origin, and head and neck or unknown primary. When mixed histology (ex, adenocarcinoma, squamous cell carcinoma or transitional carcinoma) is found, small cell carcinoma or neuroendocrine carcinoma should be the predominant part.
• Measurable lesions by RECIST 1.1 within 28 days prior to the first dose of tarlatamab.
• ECOG Performance Status (PS) of 0 or 1.
• Age greater or equal to 18 years old.
• Subjects willing to provide archived tumor tissue samples (formalin fixed, paraffin embedded \[FFPE\] sample) or willing to undergo pretreatment tumor biopsy.
• Subjects with treated brain metastases are eligible provided they meet the following criteria:
• Definitive therapy was completed at least 2 weeks prior to the first dose of tarlatamab.
• There is no evidence of radiographic central nervous system (CNS) progression following definitive therapy and by the time of study screening.
• Any CNS disease is asymptomatic for at least 7 days (unless symptoms are deemed irreversible by the investigator), the patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the subject is off or on stable doses of anti-epileptic drugs for malignant CNS disease for at least 7 days.
• Adequate organ function, defined as follows:
• hematological function:
• absolute neutrophil count ≥ 1.5 x 109/L
• platelet count ≥ 100 x 109/L

You may not qualify if:

• Uncontrolled brain metastasis and leptomeningeal disease.
• Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
• Prior exposure to DLL3 targeting agent.
• Subjects who experienced recurrent pneumonitis (grade 2 or higher) or severe, life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents.
• Unresolved toxicity from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1, or to levels dictated in the eligibility criteria with the exception of alopecia or toxicities from prior anti-tumor therapy that are considered irreversible (defined as having been present and stable for \> 21 day) which may be allowed.
• History of other malignancy within the past 2 years, with the following exceptions:
• malignancy treated with curative intent and with no known active disease present for \> 2 years before enrollment and felt to be at low risk for recurrence by the treating physician.
• 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 non-invasive carcinoma or carcinoma in situ.
• Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association \> class II) within 12 months of first dose of tarlatamab.
• History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 12 months of first dose of tarlatamab.
• Presence of fungal, bacterial, viral, or other infection requiring oral or IV antimicrobials for management within 7 days of first dose of tarlatamab with the exception:

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Amgen: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, Please Select, 100056, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Neuroendocrine

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

Jhe-Cyuan Guo

CONTACT

+886-223220322; jhecyuanguo@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 10, 2025
• Study Start: May 15, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): April 30, 2029
• Last Updated: February 10, 2025

Record last verified: 2025-02

Locations

TW (1)