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 — DRUGTarlatamab 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 ExplorationThe 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 ExpansionParticipants 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | - |
| University of California at San Francisco Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94158 | - |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | 30322 | - |
| University of Chicago | Chicago | Illinois | 60637 | - |
| Community Health Network MD Anderson Cancer Center - North | Indianapolis | Indiana | 46250 | - |
| Washington University | St Louis | Missouri | 63110-1093 | - |
| Weill Cornell Medical College | New York | New York | 10021 | - |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27103 | - |
| The Ohio State University | Columbus | Ohio | 43210 | - |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | - |
Related coverage on Hipa.ai
- Tarlatamab Phase 1 Trial in Neuroendocrine Prostate Cancer Shows 12% ORRTarlatamab · Sep 12, 2025 · ClinicalTrials.gov
Find similar trials in Phoenix, AZ
By research site
Mayo Clinic Arizona· Phoenix, AZUniversity of California at San Francisco Helen Diller Family Comprehensive Cancer Center· San Francisco, CAWinship Cancer Institute of Emory University· Atlanta, GAUniversity of Chicago· Chicago, ILCommunity Health Network MD Anderson Cancer Center - North· Indianapolis, INWashington University· St Louis, MO
Related Studies
- Phase I Study of [225Ac]Ac-ETN029 in Patients With Advanced DLL3-expressing Solid TumorsPHASE1 · Recruiting · Novartis Pharmaceuticals · Iowa City, Iowa