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

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Amgen
Study ID
NCT07037758
Phase
PHASE1
Status
Recruiting
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Conditions

  • Extensive Stage Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Tarlatamab — DRUG
    Administered as an IV infusion.
  • AB248 — DRUG
    Administered either as an IV infusion followed by a flush or using a syringe pump without a flush.

Study Details

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.

Key Dates

Start date
Sep 16, 2025
Status verified
May 2026
Primary completion
Mar 18, 2028
Completion
Jan 18, 2031

Study Design

Enrollment
380 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Number of Participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to 2.5 years ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
Banner MD Anderson Cancer CenterGilbertArizona85234-
University of Southern California, Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
Moffitt Cancer CenterTampaFlorida33612-
Emory UniversityAtlantaGeorgia30322-
Norton Cancer Institute - DowntownLouisvilleKentucky40202-1703-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Siteman Cancer CenterSt LouisMissouri63110-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10021-
Sidney Kimmel Cancer CenterPhiladelphiaPennsylvania19107-
Allegheny General HospitalPittsburghPennsylvania15212-
Avera Cancer InstituteSioux FallsSouth Dakota57105-
Baptist Cancer CenterMemphisTennessee38120-
Swedish Cancer Institute Medical OncologySeattleWashington98109-

Find similar trials in Gilbert, AZ

By research site
Banner MD Anderson Cancer Center· Gilbert, AZUniversity of Southern California, Norris Comprehensive Cancer Center· Los Angeles, CAMoffitt Cancer Center· Tampa, FLEmory University· Atlanta, GANorton Cancer Institute - Downtown· Louisville, KYDana-Farber Cancer Institute· Boston, MA

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