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

ConditionsNeuroendocrine Carcinomas (NEC)Neuroendocrine Carcinoma of PancreasNeuroendocrine Carcinoma of Prostate
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorInkeun Park

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Subject is asymptomatic from brain metastases

Whole brain radiation or surgery was completed at least 2 weeks prior to first dose of study treatment (stereotactic radiosurgery completed at least 7 days prior to first dose of study treatment)

Any CNS disease is clinically stable, subject is off steroids for CNS disease for at least 5 days (unless steroids are indicated for a reason unrelated to CNS disease), and subject is off or on stable doses of anti-epileptic drugs at least 14 days prior to first dose of study treatment • Subjects with untreated brain metastases that are asymptomatic and do not require corticosteroids, nor local therapy per investigators standard of practice are allowed Diagnosis or evidence of leptomeningeal disease.

Any severe or life-threatening immune-mediated adverse event, History of immune-mediated encephalitis or other immune-mediated CNS event (any grade)

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: All patientExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

defined as the percentage of participants who have a partial response or complete response based on investigator assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

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

Secondary outcomes

1

Progression free survival (PFS)

defined as time from treatment initiation until disease progression or death from any cause, whichever occurs first for all subjects. Progression will be based on investigator assessment of disease response per RECIST 1.1

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
2

Overall Survival(OS)

defined as time from treatment initiation until death from any cause

Time frame
From the date of the safety follow-up visit for up to 36 months after the last subject is enrolled or 1 year after the last subject's final dose of study treatment, whichever is later
3

Duration of response (DOR)

defined as the time from the first documentation of OR until the first documentation of disease progression or death due to any cause, whichever occurs first. Only subjects who have achieved OR will be evaluated for DOR

Time frame
From the date of the first recorded objective response (partial response [PR] or complete response [CR]) for up to 36 months, until the first documented date of disease progression or death from any cause, whichever occurs first.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Inkeun Park

Lead sponsor

Asan Medical Center

Sponsor institution

Seoul National University Hospital

Collaborator

Severance Hospital

Collaborator

Samsung Medical Center

Collaborator

Source ClinicalTrials.gov
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