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Recruiting

NCT Number: NCT06598306

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chris OBrien Lifehouse, Camperdown, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tarlatamab

Drug

Administered by SC injection.

Other names: AMG 757, Imdelltra

Primary outcomes

  1. Number of Participants with Dose-limiting toxicities (DLTs)

    Time frame: Up to day 21

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

    Time frame: Up to approximately 24 months

  3. Number of Participants with Changes in Vital Signs

    Time frame: Up to approximately 24 months

  4. Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests

    Time frame: Up to approximately 24 months

Secondary outcomes

  1. Maximum Serum Concentration (Cmax) of Tarlatamab

    Time frame: Up to approximately 12 months

  2. Serum Concentration Prior to Dosing (Ctrough) of Tarlatamab

    Time frame: Up to approximately 12 months

  3. Time to Cmax (Tmax) of Tarlatamab

    Time frame: Up to approximately 12 months

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

    Time frame: Up to approximately 12 months

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

    Time frame: Up to approximately 24 months

  6. Duration of Response (DOR) per RECIST 1.1

    Time frame: Up to approximately 24 months

  7. Time to Response (TTR) per RECIST 1.1

    Time frame: Up to approximately 24 months

  8. Progression-free Survival (PFS) per RECIST 1.1

    Time frame: Up to approximately 24 months

  9. Time to Progression per RECIST 1.1

    Time frame: Up to approximately 24 months

  10. Time to Subsequent Therapy

    Time frame: Up to approximately 24 months

  11. Overall Survival (OS)

    Time frame: Up to approximately 24 months

  12. Number of Participants with Anti-tarlatamab Antibody Formation

    Time frame: Up to approximately 24 months

Study contacts

Contact information is provided by the study sponsor or research team.

Amgen Call Center

CONTACT

[email protected]

866-572-6436

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Collaborators

  • BeOne Medicines

Registry information

Official study title

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)

Acronym: DeLLphi-308

Important dates

Study start
2024
Primary completion
2027
Study completion
2030
First posted
Sep 19, 2024
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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