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Metastatic Prostate CancerPhase 2NCT07111507

A Study of Tarlatamab for People With Prostate Cancer

A Phase 2 study testing Tarlatamab in people with Metastatic Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 10 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Metastatic Prostate Cancer
What is being tested?
Tarlatamab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
10 sitesUnited States
Study dates
31 Jul 2025to 31 Aug 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • Note: Measurable disease by RECIST 1.1 criteria is not required; however, a minimum of 50% of participants enrolled must have measurable disease by RECIST 1.1 criteria.
  • 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:
  • Prostate-specific antigen (PSA) progression defined as a minimum of 2 rising PSA levels with a minimum of a 1-week interval between each determination. There is no minimum PSA level required.
  • Nodal or visceral progression as defined by RECIST 1.1 with PCWG3 modifications
  • Progression of bone disease with two or more new bone lesions on bone scan (i.e., PCWG3)
  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Karen Autio, MD contact

646-422-4632

autiok@mskcc.org

Michael Morris, MD contact

646-422-4469

10 sites in 1 country

United States10 sites, 10 recruiting

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey, 07920

    Karen Autio, MD, 646-422-4632

    Recruiting

  • Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

    Commack, New York, 11725

    Karen Autio, MD, 646-422-4632

    Recruiting

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York, 10604

    Karen Autio, MD, 646-422-4632

    Recruiting

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jersey, 07748

    Karen Autio, MD, 646-422-4632

    Recruiting

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey, 07645

    Karen Autio, MD, 646-422-4632

    Recruiting

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York, 10065

    Karen Autio, MD, 646-422-4632

    Recruiting

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

    Kayvan Zarrabi, MD, 215-955-8874

    Recruiting

  • UNIVERSITY OF CALIFORNIA SAN DIEGO (Data collection only)

    San Diego, California, 92103

    Rana McKay, MD, 858-657-7876

    Recruiting

  • University of California San Francisco

    San Francisco, California, 94143

    Rahul Aggarwal, MD, 858-657-7876

    Recruiting

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Uniondale, New York, 11553

    Karen Autio, MD, 646-422-4632

    Recruiting

Other trials in United States

About this study

Official title: TIDAL: Phase 2 Study of Tarlatamab in Patients With Delta-like Protein 3 (DLL3) Positive Metastatic Prostate Cancer

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).

Being tested
Tarlatamab
Keywords
Tarlatamab, Delta-like protein expression 3 (DLL3), 25-138
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TarlatamabDrug

    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.

Study groups in NCT07111507
Study groupRoleWhat they receive
TarlatamabExperimentalParticipants will be treated with a 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.
Receives: Drug: Tarlatamab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. progression free survival (rPFS)

    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.

    Measured: up to 24 weeks

Secondary outcomes (1)

  1. overall response rate (ORR)

    The assessment of responses for soft tissue disease will use PCWG3-modified RECIST 1.1. Responses (CR, PR) and must be confirmed at least 4 weeks after first observation.

    Measured: up to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2025
  2. Study start31 Jul 2025
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a phase 2, open label, single arm, multisite study.
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07111507
Sponsor's protocol ID
25-138
Other IDs
PCCTC #: c24-347
Status last verified
Aug 2026
First submitted
1 Aug 2025
Last updated
31 Aug 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tarlatamab in people with Metastatic Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Karen Autio, MD (646-422-4632, autiok@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression free survival (rPFS) (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07111507.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.

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