Print

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

Emory University
Atlanta 4180439, Georgia 4197000 30322

Norton Cancer Institute - Downtown
Louisville 4299276, Kentucky 6254925 40202-1703

Siteman Cancer Center
St Louis 4407066, Missouri 4398678 63110

Sidney Kimmel Cancer Center
Philadelphia 4560349, Pennsylvania 6254927 19107

Allegheny General Hospital
Pittsburgh 5206379, Pennsylvania 6254927 15212

Baptist Cancer Center
Memphis 4641239, Tennessee 4662168 38120

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.