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

Conditions

• Advanced Tumors
• DLL3-expressing Tumors

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

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.

Key Dates

Start date

Mar 21, 2025

Status verified

May 2026

Primary completion

Apr 24, 2028

Completion

Apr 24, 2029

Study Design

Enrollment

29 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Tarlatamab treatment
  Tarlatamab will be administered as a 60-minute intravenous (IV)

Primary Outcome Measure

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 ]

Central Contacts

• CRU Hotline
  888-798-0719
  [email protected]
• CRU Direct line
  310-206-2632

Locations (5)

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