Recruiting
Phase 1

Tarlatamab & AB248

Sponsor:

Amgen

Code:

NCT07037758

Conditions

Extensive Stage Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Tarlatamab

AB248

Study Details

Brief summary:

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.

Conditions

Extensive Stage Small Cell Lung Cancer

Study ID

NCT07037758

Start date

Sep 16, 2025

Status verified date

May, 2026

Completion date

Jan 18, 2031

Anticipated

Primary completion date

Mar 18, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Participant has provided informed consent before initiation of any study-specific activities/procedures.
2. Participants ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent.
3. 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.
4. Participants must have at least 1 measurable lesion as defined by RECIST 1.1 within 21-day screening period, not previously irradiated.
5. Participants must have adequate organ function (hematological, coagulation, cardiac, pulmonary, kidney, and liver).
6. 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:

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

Study Design

Enrollment

380 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Exploration

Multiple dose levels of AB248 will be explored in combination with tarlatamab administered via intravenous (IV) infusion.

experimental: Dose Expansion

The dose expansion part will test tarlatamab in combination with the MTCD/recommended dose for expansion of AB248 identified in the dose exploration part.

An optional cohort may be opened based on emerging data to study tarlatamab in combination with AB248 at a lower dose than the MTCD/recommended dose for expansion or with an alternative dose regimen at a AB248 dose lower than or equal to MTCD/recommended dose for expansion.

Interventions

Tarlatamab

Administered as an IV infusion.

AB248

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

Primary outcome measure

  • Number of Participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to 2.5 years ]
  • Dose Exploration: Number of Participants with Dose-limiting Toxicities (DLTs) [ Time Frame: Up to 35 days ]

Central Contacts and Locations

Central contacts

Locations

Banner MD Anderson Cancer Center

Recruiting

Gilbert, Arizona, United States, 85234

University of Southern California, Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Norton Cancer Institute - Downtown

Recruiting

Louisville, Kentucky, United States, 40202-1703

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Siteman Cancer Center

Recruiting

St Louis, Missouri, United States, 63110

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10021

Sidney Kimmel Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Allegheny General Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Avera Cancer Institute

Recruiting

Sioux Falls, South Dakota, United States, 57105

Baptist Cancer Center

Recruiting

Memphis, Tennessee, United States, 38120

Swedish Cancer Institute Medical Oncology

Recruiting

Seattle, Washington, United States, 98109

More Information

Sponsor

Amgen

Last update posted

May 29, 2026

Last verified

May, 2026

Keywords

  • ES-SCLC
  • Tarlatamab
  • AMG 757
  • AB248
  • Imdelltra

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Amgen on 2026-05-29.