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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 90 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dose Exploration 		Multiple dose levels of AB248 will be explored in combination with tarlatamab administered via intravenous (IV) infusion.
  • Drug: Tarlatamab
    Administered as an IV infusion.
    Other names:
    • AMG 757
    • Imdelltra
  • Drug: AB248
    Administered either as an IV infusion followed by a flush or using a syringe pump without a flush.
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.
  • Drug: Tarlatamab
    Administered as an IV infusion.
    Other names:
    • AMG 757
    • Imdelltra
  • Drug: AB248
    Administered either as an IV infusion followed by a flush or using a syringe pump without a flush.

Recruiting Locations

Banner MD Anderson Cancer Center
Gilbert, Arizona 85234

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

Moffitt Cancer Center
Tampa, Florida 33612

Emory University
Atlanta, Georgia 30322

Norton Cancer Institute - Downtown
Louisville, Kentucky 40202-1703

Dana-Farber Cancer Institute
Boston, Massachusetts 02215

Memorial Sloan Kettering Cancer Center
Boston, Massachusetts 02215

Siteman Cancer Center
St Louis, Missouri 63110

Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania 19107

Allegheny General Hospital
Pittsburgh, Pennsylvania 15212

Avera Cancer Institute
Sioux Falls, South Dakota 57105

Baptist Cancer Center
Memphis, Tennessee 38120

Swedish Cancer Institute Medical Oncology
Seattle, Washington 98109

More Details

Status
Recruiting
Sponsor
Amgen

Study Contact

Amgen Call Center
866-572-6436
medinfo@amgen.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.