NCT07111507 · Memorial Sloan Kettering Cancer Center
A Study of Tarlatamab for People With Prostate Cancer
What this study is about
The researchers are doing this study to find out whether tarlatamab is an effective treatment for Delta-like Protein 3 (DLL3)-positive prostate cancer that has spread to other parts of your body (metastasized) and has either come back after treatment (relapsed) or not responded to treatment (refractory).
View original scientific description
The researchers are doing this study to find out whether tarlatamab is an effective treatment for Delta-like Protein 3 (DLL3)-positive prostate cancer that has spread to other parts of your body (metastasized) and has either come back after treatment (relapsed) or not responded to treatment (refractory).
Interventions
DRUG
Tarlatamab
Patients receive lower dose of tarlatamab on Cycle 1 Day 1 (D1) followed by the full dose on Cycle 1 days 8, 15 and days 1 and 15 for all subsequent cycles.
Primary outcome measures
progression free survival (rPFS)
Time frame: up to 24 weeks
as measured by the 24-week rPFS rate per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) with Prostate Cancer Working Group 3 (PCWG3) modifications for soft tissue disease and PCWG3 criteria for bone disease.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- To be included in this study, participants should complete all screening procedures and meet all of the following criteria:
- Willing and able to provide, or have a legally authorized representative provide, written informed consent and privacy authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed. NOTE: Privacy authorization may be either included in the informed consent or obtained separately.
- 18 years of age and above
- Resting oxygen saturation of ≥ 90% on room air.
- Histologically confirmed prostate cancer. Any histologic subtype of prostate cancer is allowed.
- Documented metastatic disease based on conventional imaging (soft tissue disease on computed topography (CT)/magnetic resonance imaging (MRI), or at least 2 lesions as found on bone scan) obtained during Screening. Metastatic disease as seen only on PET scan is
Exclusion criteria
- ary. Metastatic disease may includ
Where
- San Diego, California
- San Francisco, California
- Basking Ridge, New Jersey
- Middletown, New Jersey
- Montvale, New Jersey
- Commack, New York
- Harrison, New York
- New York, New York
- Uniondale, New York
- Philadelphia, Pennsylvania
Collaborators
Amgen
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 17, 2026 · Source of record for eligibility and locations