NCT06788938

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

Tarlatamab in Advanced DLL3-Expressing Tumors Including Neuroendocrine Neoplasms

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a phase II, multicenter, basket trial to evaluate the safety, tolerability, and efficacy of tarlatamab in DLL3-expressing tumors. The study will enroll patients with advanced tumors, other than small cell lung cancer or neuroendocrine prostate cancer, that are confirmed to exhibit DLL3 expression. Patients will be treated with tarlatamab until disease progression, death, unacceptable adverse effects, or withdrawal of consent. A Simon's two-stage optimum design will be used \[1\]. The primary objective of this phase II trial is the overall response rate (ORR, as defined by confirmed complete and partial response) per RECIST v1.1 criteria. Our null hypothesis is an ORR of 10% or lower, based on the requirements for prior therapies, and our alternative hypothesis is an ORR of 30% or greater. We will utilize a Simon two-stage design, in which 10 patients will be entered into the first stage. If 2 or more patients show a response, then an additional 19 patients will be enrolled. If 6 or more patients out of 29 show a response, then the trial will reject the null hypothesis.

Conditions

• DLL3-expressing Tumors
• Advanced Tumors

Interventions

Type	Name	Description
DRUG	Tarlatamab treatment	* 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

Timeline

• Start date: 2025-03-21
• Primary completion: 2028-04-24
• Completion: 2029-04-24
• First posted: 2025-01-23
• Last updated: 2026-03-20

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study