Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Amgen
Study ID
NCT06598306
Phase
PHASE1
Status
Recruiting

Conditions

  • Extensive Stage Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.

Key Dates

Start date
Oct 7, 2024
Status verified
May 2026
Primary completion
Mar 3, 2027
Completion
Apr 24, 2030

Study Design

Enrollment
220 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Part 1 Dose Exploration
    Tarlatamab will be administered as a SC injection in Part 1.
  • Experimental: Part 2 Dose Expansion
    Following the selection of a SC dosing regimen in Part 1, tarlatamab will be administered in Part 2 at the dose deemed safe and tolerable in Part 1.
  • Experimental: Part 3 Alternative Dosing
    Following the selection of a SC dosing regimen from Part 1 that will be used in Part 2 dose expansion, Part 3 may open to test alternative dosing of SC tarlatamab.

Primary Outcome Measure

Number of Participants with Dose-limiting toxicities (DLTs) [ Time Frame: Up to day 21 ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of Southern California, Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
University of Illinois ChicagoChicagoIllinois60612-
Trinity Health Saint Joseph Mercy Ann ArborAnn ArborMichigan48106-
Avera Cancer InstituteSioux FallsSouth Dakota57105-
University of Texas MD Anderson Cancer CenterHoustonTexas77030-
Swedish Cancer InstituteSeattleWashington98104-

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