A Study of Tarlatamab for Metastatic Prostate Cancer
This study is testing a drug called tarlatamab for men with prostate cancer that has spread to other parts of the body (metastasized). This is for prostate cancer that has either come back after treatment (relapsed) or hasn't responded to treatment (refractory) and is also Delta-like Protein 3 (DLL3)-positive. Researchers want to see if tarlatamab is an effective treatment. You would receive a lower dose of tarlatamab at first, followed by a full dose on specific days in each cycle. The main goal is to see how long people live without their cancer getting worse (progression-free survival) for up to 24 weeks. The study is currently recruiting about 32 participants.
- Study design
- This is an interventional study with about 32 participants. It is testing the drug tarlatamab.
- What's involved
- You would receive tarlatamab on specific days during treatment cycles. The study measures how long you live without your cancer getting worse for up to 24 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint, progression-free survival, is measured at up to 24 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07111507
A Study of Tarlatamab for People With Prostate Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentMemorial Sloan Kettering Cancer CenterInvestigator-initiated
~32 participants
Updated 2026-06-17 on ClinicalTrials.gov
What's tested:Tarlatamab
At a glance
Recruiting sites
10 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
progression free survival (rPFS)
Measured over up to 24 weeks
Conditions
Where it's being run
10 sites across 4 statesNew York4
New Jersey3
California2
Pennsylvania1
Study leadership
- Karen Autio, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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.
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 exclusionary. Metastatic disease may include pelvic lymph nodes above and/or below the aortic bifurcation.
Serum testosterone ≤ 50 ng/dL with ongoing androgen-deprivation therapy (ADT) or de novo small cell NEPC (neither testosterone levels nor ADT are required in participants with de novo small cell NEPC).
Progression on at least one line of therapy in the metastatic setting based on at least one of the following criteria:
Participants with de novo small cell NEPC are required to have received prior platinum-based chemotherapy or be ineligible for this treatment.
No more than two prior lines of cytotoxic chemotherapy in the metastatic castration-resistant disease setting or the de novo small cell NEPC setting
DLL3 positive disease as defined by archival or fresh tumor biopsy with positive DLL3 expression using a CLIA certified assay (50% or more of tumor cells with DLL3 expression by IHC). DLL3 testing may be obtained at any point prior to study enrollment
Participants with brain metastases are eligible provided definitive treatment completed at least two weeks prior to C1D1, no concurrent steroids for the treatment of central nervous system (CNS) disease, and no progression noted on CNS imaging obtained during screening obtained following completion of definitive treatment.
ECOG status of ≤ 2
Normal organ function with acceptable initial laboratory values within 14 days of treatment start. Red blood cell transfusions during screening may be allowed if laboratory values initially fall outside of the following ranges:
Absolute neutrophil count (ANC) ≥ 1,500/μ
Hemoglobin ≥9g/dL
Platelet count ≥75,000/μl
Bilirubin ≤ 1.5 upper limit of normal (ULN) or \< 2 if liver metastases or Gilbert's disease
SGOT (AST) \< 3 x ULN or \< 5 if liver metastases
SGPT (ALT) \< 3 x ULN or \< 5 if liver metastases
Adequate renal function CrCl ≥ 30mL/min using Cockroft Gault or MDRD calculation
Participants must agree to use a medically acceptable method of birth control (e.g., spermicide in conjunction with a barrier such as a condom) or sexual abstinence for the duration of the study, including 60 days after the last dose of study drug. Sperm donation is prohibited during the study and for 60 days after the last dose of study drug. Female partners must use hormonal or barrier contraception unless postmenopausal or abstinent.
Exclusion
Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessments in the judgment of the site Principal Investigator (PI).
Medical conditions such as uncontrolled hypertension (sustained SBP \> 160 mm Hg or diastolic BP \> 100 mm Hg), any history of seizure, or major cardiovascular event (myocardial infarction), stroke or transient ischemia event within 6 months prior to study entry, or NYHA class ≥ III congestive heart failure, or uncontrolled cardiac arrhythmia.
Active hepatitis B or C infection (defined as positive HBsAg or positive HBV DNA in participants who are HBV core Ab +; detectable HCV RNA by PCR). Prior treatment for HBV or HCV is allowed.
Active human immunodeficiency (HIV) infection on antiviral therapy as measured by a detectable viral load.
History of leptomeningeal disease.
Active autoimmune disease requiring systemic treatment within the past 2 years or Grade \> 2 autoimmune adverse effect from prior immune checkpoint inhibition (exception: any grade endocrine disorders on replacement treatment are allowed). Prednisone or equivalent at doses of up to 10 mg/day along with oral weekly methotrexate are allowed. No other immunosuppressive medications are allowed
History of interstitial lung disease and/or Grade ≥ 2 pneumonitis at the time of study entry
Diagnosis of immunodeficiency or receiving systemic steroid therapy (prednisone \> 10 mg/day or equivalent) within 7 days of C1D1
Presence of infection requiring IV antibiotics within 7 days of C1D1
Prior DLL3-targeting treatment
Systemic anti-cancer treatment (other than LHRH analog) within 14 days or 5 half-lives, whichever is shorter, prior to C1D1
Receipt of another investigational therapeutic agent within 14 days or 5 half-lives, whichever is shorter, prior to C1D1
Major surgical procedure within 28 days prior to C1D1
Palliative radiotherapy if \< 1 week prior to C1D1
Use of any prohibited concomitant medications (Appendix C: Medications With the Potential for Drug-Drug Interactions) within two weeks prior to C1D1.
Grade \> 2 treatment-related adverse event related to prior therapy that is ongoing at the start of study treatment.
Known allergy to any of the compounds under investigation
Any other condition which, in the opinion of the Investigator, would preclude participation in this trial
What this trial measures
- progression free survival (rPFS)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.