A Study of AMG 757 in Participants With Neuroendocrine Prostate Cancer

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Amgen
Study ID
NCT04702737
Phase
PHASE1
Status
Completed

Conditions

  • Neuroendocrine Prostate Cancer

Eligibility Criteria

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

Interventions

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

Study Details

To evaluate the safety and tolerability of Tarlatamab and will determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D).

Key Dates

Start date
Jun 10, 2021
Status verified
Aug 2025
Primary completion
Jul 22, 2024
Completion
Jul 22, 2024

Study Design

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

Arms

  • Experimental: Part 1: Dose Exploration
    The maximum tolerated dose (MTD) will be estimated using isotonic regression (Ji et al, 2010). The recommended phase 2 dose (RP2D) may be identified based on emerging safety data prior to reaching an MTD.
  • Experimental: Part 2: Dose Expansion
    Participants will receive the RP2D/MTD identified in Part 1 (dose exploration) of the study.

Primary Outcome Measure

Number of Participants Who Experienced One or More Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to approximately 3 years ]

Locations (10)

FacilityCityStateZIPSite coordinators
Mayo Clinic ArizonaPhoenixArizona85054-
University of California at San Francisco Helen Diller Family Comprehensive Cancer CenterSan FranciscoCalifornia94158-
Winship Cancer Institute of Emory UniversityAtlantaGeorgia30322-
University of ChicagoChicagoIllinois60637-
Community Health Network MD Anderson Cancer Center - NorthIndianapolisIndiana46250-
Washington UniversitySt LouisMissouri63110-1093-
Weill Cornell Medical CollegeNew YorkNew York10021-
Wake Forest University Health SciencesWinston-SalemNorth Carolina27103-
The Ohio State UniversityColumbusOhio43210-
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

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