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NCT Number: NCT07037758

A Study of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311)

The primary objective for dose exploration and dose expansion is to evaluate the safety and tolerability of tarlatamab in combination with AB248.

The primary objective for dose exploration only is to determine the recommended dose for expansion and/or maximum tolerated combination dose (MTCD) of AB248 in combination with tarlatamab.

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Key information

Conditions

Extensive Stage Small Cell Lung Cancer

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chungbuk National University Hospital, Cheongju Chungbuk, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participant has provided informed consent before initiation of any study-specific activities/procedures.
  • Participants ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent.
  • Participants with histologically or cytologically confirmed ES-SCLC that has progressed or recurred following at least 1 line of anti-cancer therapy for ES-SCLC.
  • Participants must have at least 1 measurable lesion as defined by RECIST 1.1 within 21-day screening period, not previously irradiated.
  • Participants must have adequate organ function (hematological, coagulation, cardiac, pulmonary, kidney, and liver).
  • Participants must submit a fresh tumor biopsy at screening unless a new biopsy cannot be performed safely or is infeasible. Participants who cannot provide fresh tissue may provide archival tissue that was collected after last anticancer therapy.

Exclusion criteria

  • Symptomatic central nervous system (CNS) metastases.
  • Participants with brain metastases may be eligible if criteria defined in the protocol are met.
  • Prior therapy with any delta-like ligand 3 (DLL3)-directed therapy (including tarlatamab).
  • Prior interleukin (IL)-2, IL-7 or IL-15 targeted therapy.
  • Baseline (at rest) requirement of supplemental oxygen.

Treatment and study plan

Tarlatamab

Drug

Administered as an IV infusion.

Other names: AMG 757, Imdelltra

AB248

Drug

Administered either as an IV infusion followed by a flush or using a syringe pump without a flush.

Primary outcomes

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

    Time frame: Up to 2.5 years

    Clinically significant changes in vital signs and clinical laboratory tests will be reported as adverse events.

  2. Dose Exploration: Number of Participants with Dose-limiting Toxicities (DLTs)

    Time frame: Up to 35 days

Secondary outcomes

  1. Maximum Serum Concentration (Cmax) of Tarlatamab

    Time frame: Up to approximately 21 weeks

  2. Minimum Serum Concentration (Cmin) of Tarlatamab

    Time frame: Up to approximately 21 weeks

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

    Time frame: Up to approximately 21 weeks

  4. Half-life (t1/2) of Tarlatamab

    Time frame: Up to approximately 21 weeks

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

    Time frame: Up to 2.5 years

  6. Duration of Response (DOR) per RECIST 1.1

    Time frame: Up to 2.5 years

  7. Time to Response (TTR) per RECIST 1.1

    Time frame: Up to 2.5 years

  8. Disease Control (DC) per RECIST 1.1

    Time frame: Up to 2.5 years

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

    Time frame: Up to 2.5 years

  10. Time to Progression (TTP) per RECIST 1.1

    Time frame: Up to 2.5 years

  11. Time to Subsequent Therapy

    Time frame: Up to 2.5 years

  12. Overall Survival (OS)

    Time frame: Up to 2.5 years

  13. Number of Participants with Anti-AB248 Antibody Formation

    Time frame: Up to 2.5 years

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

  • Asher Biotherapeutics, Inc.

Registry information

Official study title

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311)

Acronym: DeLLphi-311

Important dates

Study start
2025
Primary completion
2028
Study completion
2031
First posted
Jun 25, 2025
Registry last updated
May 29, 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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