Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)

Description

The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.

Conditions

Extensive Stage Small Cell Lung Cancer

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Study Overview

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Study Details

Study overview

The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of Subcutaneous Tarlatamab in Subjects With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)

Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)

Condition
Extensive Stage Small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Los Angeles

University of Southern California, Norris Comprehensive Cancer Center, Los Angeles, California, United States, 90033

Sioux Falls

Avera Cancer Institute, Sioux Falls, South Dakota, United States, 57105

Seattle

Swedish Cancer Institute, Seattle, Washington, United States, 98104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Participants ≥ 18 years of age (or ≥ legal adult age within country if it is older than 18 years) at time of signing informed consent.
  • * Participants with histologically or cytologically confirmed ES-SCLC that progressed or recurred following at least one line of platinum-based regimen.
  • * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
  • * Participants must have adequate organ function (cardiac, pulmonary, kidney, and liver).
  • * Participants must be able to have SC injections administered in the abdomen (and/or thigh).
  • * Participants without measurable disease or tumor tissue (fresh biopsy or archival) available may be permitted after discussion with and approval by Amgen Medical Monitor.
  • * Participants that have received prior DLL3 targeted therapy.
  • * Participants with untreated or symptomatic brain metastases or those requiring therapy with steroids.
  • * Note: Participants with asymptomatic brain metastatic lesions are allowed following definitive treatment (Amgen Medical Monitor may approve untreated, asymptomatic brain metastasis if local therapy is not required per investigator judgment).
  • * Participants with leptomeningeal disease.
  • * Participants with baseline oxygen requirement.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Amgen,

MD, STUDY_DIRECTOR, Amgen

Study Record Dates

2028-05-01