Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingInterventionalPhase 1

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)

NCT ID: NCT06598306Sponsor: AmgenLast updated: 2026-05-29

Summary

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

Arms & interventions

  • DrugTarlatamab

    Administered by SC injection.

Outcome measures

Primary

  • Number of Participants with Dose-limiting toxicities (DLTs)

    Time frame: Up to day 21

  • Number of Participants with Treatment-emergent Adverse Events (TEAEs)

    Time frame: Up to approximately 24 months

  • Number of Participants with Changes in Vital Signs

    Time frame: Up to approximately 24 months

  • Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests

    Time frame: Up to approximately 24 months

Secondary

  • Maximum Serum Concentration (Cmax) of Tarlatamab

    Time frame: Up to approximately 12 months

  • Serum Concentration Prior to Dosing (Ctrough) of Tarlatamab

    Time frame: Up to approximately 12 months

  • Time to Cmax (Tmax) of Tarlatamab

    Time frame: Up to approximately 12 months

  • Area Under the Concentration-time Curve (AUC) of Tarlatamab

    Time frame: Up to approximately 12 months

  • Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

    Time frame: Up to approximately 24 months

  • Duration of Response (DOR) per RECIST 1.1

    Time frame: Up to approximately 24 months

  • Time to Response (TTR) per RECIST 1.1

    Time frame: Up to approximately 24 months

  • Progression-free Survival (PFS) per RECIST 1.1

    Time frame: Up to approximately 24 months

  • Time to Progression per RECIST 1.1

    Time frame: Up to approximately 24 months

  • Time to Subsequent Therapy

    Time frame: Up to approximately 24 months

  • Overall Survival (OS)

    Time frame: Up to approximately 24 months

  • Number of Participants with Anti-tarlatamab Antibody Formation

    Time frame: Up to approximately 24 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion 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 anti-cancer therapy for SCLC. Note: Participants with prior treatment for LS-SCLC should have also received another regimen for their recurrent, ES-SCLC disease. * 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. * Participants without measurable disease or tumor tissue (fresh biopsy or archival) available may be permitted after discussion with and approval by Amgen Medical Monitor. Exclusion Criteria: * 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.

Study locations (6)

University of Southern California, Norris Comprehensive Cancer Center

Los Angeles, California, 90033

Recruiting

University of Illinois Chicago

Chicago, Illinois, 60612

Recruiting

Trinity Health Saint Joseph Mercy Ann Arbor

Ann Arbor, Michigan, 48106

Recruiting

Avera Cancer Institute

Sioux Falls, South Dakota, 57105

Recruiting

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

Recruiting

Swedish Cancer Institute

Seattle, Washington, 98104

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