AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Amgen
Study ID
NCT04885998
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Tarlatamab — DRUG
    Tarlatamab will be administered as an intravenous (IV) infusion.
  • AMG 404 — DRUG
    AMG 404 will be administered as an intravenous (IV) infusion.

Study Details

The main purpose of this study is to evaluate the safety, tolerability, and recommended phase 2 target dose of tarlatamab in combination with AMG 404.

Key Dates

Start date
Sep 27, 2021
Status verified
Aug 2025
Primary completion
Jul 12, 2023
Completion
Sep 11, 2024

Study Design

Enrollment
23 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1: Dose Exploration
    The recommended phase 2 target dose (RP2D) of tarlatamab in combination with AMG 404 will be estimated using a modified toxicity probability interval (mTPI-2) design. A combination RP2D may be identified based on emerging safety, efficacy, and pharmacodynamic data prior to reaching an maximum tolerated dose (MTD).
  • Experimental: Phase 2: Dose Expansion
    Participants will receive the RP2D of tarlatamab in combination with AMG 404 identified in Phase 1 (dose exploration) of the study.

Primary Outcome Measure

Part 1: Number of Participants Who Experienced Dose-limiting Toxicity (DLT) [ Time Frame: First dose of tarlatamab up to 28 days ]

Locations (7)

FacilityCityStateZIPSite coordinators
Northwestern University, Robert H Lurie Comprehensive Cancer CenterChicagoIllinois60611-
University of KentuckyLexingtonKentucky40536-
Wake Forest Baptist Comprehensive Cancer Research CenterWinston-SalemNorth Carolina27157-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Tennessee Oncology, PLLCNashvilleTennessee37203-
Huntsman Cancer InstituteSalt Lake CityUtah84112-

Find similar trials in Chicago, IL

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Northwestern University, Robert H Lurie Comprehensive Cancer Center· Chicago, ILUniversity of Kentucky· Lexington, KYWake Forest Baptist Comprehensive Cancer Research Center· Winston-Salem, NCUniversity Hospitals Cleveland Medical Center· Cleveland, OHMedical University of South Carolina· Charleston, SCTennessee Oncology, PLLC· Nashville, TN

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