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Tarlatamab in Advanced Delta-like 3 (DLL3)-Expressing Tumors Including Neuroendocrine Neoplasms

ConditionsDLL3-expressing TumorsAdvanced Tumors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJonsson Comprehensive Cancer Center

About this trial

This study is being done to learn more about the drug tarlatamab in people with your condition. The purpose of this study is to see the efficacy (how well something works) of study treatment (tarlatamab) and whether it causes any side effects. Tarlatamab is being developed as an anti-cancer drug for tumors and is FDA-approved for extensive-stage small cell lung cancer. Tarlatamab is investigational for the purpose of this study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant has provided informed consent prior to initiation of any study specific activities/procedures.

Male or female ≥ 18 years of age and willing and able to provide informed consent.

Low and intermediate grade neuroendocrine carcinoma (including carcinoid and atypical carcinoid)

Gastroenteropancreatic NEN

Disqualifiers

Diagnosis of SCLC (with the exception of SCLC transformed from previously-treated NSCLC) or NEPC.

Tumor specimen is not evaluable for DLL3 expression or tumor has DLL3 surface expression < 1% by immunohistochemistry.

Progressive or symptomatic brain metastases. Brain metastases that have been radiated, are asymptomatic, and on a stable or decreasing dose of steroids are allowed. Leptomeningeal disease is excluded.

Evidence of interstitial lung disease or active, non-infectious pneumonitis. Exception: pneumonitis related to prior radiation therapy that is grade 1 and stable or improving without treatment.

Trial design

Design model

Single group

Treatments tested in this trial

  • Tarlatamab treatment

    Drug

    * 1 mg step dose on cycle 1 day 1 (C1D1) * 10 mg target dose on cycle 1 day 8 (C1D8), and cycle 1 day 15 (C1D15) in a 28-day cycle. * 10 mg Q2W subsequently (i.e., C2 + D1/D15 dosing) in a 28-day cycle

Treatment groups

29 Participants
are divided into 1 treatment group
Group A: Tarlatamab treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

1. Primary efficacy endpoint is overall response rate (ORR) as defined as complete response (CR) or partial response (PR) by RECIST 1.1 criteria. This is evaluated in the response evaluable set of patients.

Time frame
18 months

Secondary outcomes

1

Duration of response (DOR)

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

Time frame
18 months
2

Progression free survival (PFS)

Progression free survival (PFS) is defined as time from randomization until disease progression based on RECIST 1.1, or death from any cause, whichever occurs first.

Time frame
18 months
3

Overall Survival (OS)

OS is defined as time from randomization until death from any cause.

Time frame
18 months
4

Safety and tolerability

Safety and tolerability of tarlatamab as measured by adverse events defined by Common Terminology Criteria for Adverse Events V5.0 (CTCAE 5.0). CRS and ICANS will be graded per ASTCT Consensus Grading.

Time frame
18 months

Other outcomes

1

Biomarker analysis

Assessment of potential biomarkers using tissue and based analyses

Time frame
18 months
2

Evaluate radiologic correlates

Evaluate radiologic correlates such as DLL3 PET tracer uptake at sites where this is available.

Time frame
18 months

Sponsors and contacts

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

Jonsson Comprehensive Cancer Center

Lead sponsor

Amgen

Collaborator

Source ClinicalTrials.gov
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