Actively Recruiting
A Study of Tarlatamab for People With Prostate Cancer
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-15
32
Participants Needed
10
Research Sites
108 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
A
Amgen
Collaborating Sponsor
AI-Summary
What this Trial 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).
CONDITIONS
Official Title
A Study of Tarlatamab for People With Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent before screening
- 18 years of age or older
- Resting oxygen saturation of 90% or higher on room air
- Histologically confirmed prostate cancer of any subtype
- Documented metastatic disease based on CT, MRI, or bone scan
- Serum testosterone 50 ng/dL or less with ongoing androgen-deprivation therapy or de novo small cell NEPC
- Progression after at least one line of therapy in the metastatic setting as shown by PSA rise, nodal/visceral progression, or new bone lesions
- Prior platinum-based chemotherapy received or ineligible for it if de novo small cell NEPC
- No more than two prior lines of cytotoxic chemotherapy for metastatic castration-resistant disease or de novo small cell NEPC
- DLL3 positive disease with 50% or more tumor cells expressing DLL3 by IHC
- Brain metastases allowed if definitive treatment completed at least two weeks before treatment start and no progression
- ECOG performance status 0 to 2
- Normal organ function with laboratory values within acceptable ranges within 14 days of treatment start
- Agreement to use medically acceptable birth control or sexual abstinence during the study and 60 days after last dose
You will not qualify if you...
- Any other cancer whose treatment or history could interfere with safety or efficacy assessments
- Uncontrolled high blood pressure, history of seizure, major cardiovascular event or stroke in the past 6 months, severe heart failure or uncontrolled arrhythmia
- Active hepatitis B or C infection
- Active HIV infection with detectable viral load
- History of leptomeningeal disease
- Active autoimmune disease needing systemic treatment within 2 years or severe autoimmune side effects from prior immunotherapy
- History of interstitial lung disease or significant pneumonitis at study entry
- Immunodeficiency or recent systemic steroid therapy above 10 mg/day prednisone equivalent
- Infection needing IV antibiotics within 7 days before treatment start
- Prior treatment targeting DLL3
- Recent systemic anti-cancer treatment or investigational agent within 14 days before treatment start
- Major surgery within 28 days prior to treatment
- Recent palliative radiotherapy within 1 week prior to treatment
- Use of prohibited medications with potential drug interactions within 2 weeks prior to treatment
- Ongoing severe adverse events from prior therapy
- Known allergy to study drugs
- Any condition that would prevent participation based on investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
UNIVERSITY OF CALIFORNIA SAN DIEGO (Data collection only)
San Diego, California, United States, 92103
Not Yet Recruiting
2
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
3
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
4
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
5
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
6
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
7
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
8
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
9
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
10
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
Research Team
K
Karen Autio, MD
CONTACT
M
Michael Morris, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here