Actively Recruiting
TIDAL: Phase 2 Study of Tarlatamab in Patients With Delta-like Protein 3 (DLL3) Positive Metastatic Prostate Cancer
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-15
32
Participants Needed
10
Research Sites
N/A
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
Researchers are evaluating tarlatamab as a treatment for men with Delta-like Protein 3 (DLL3)-positive metastatic prostate cancer that has spread to other parts of the body and has either returned after treatment or not responded to treatment. This Phase 2 study is sponsored by Memorial Sloan Kettering Cancer Center and aims to assess whether tarlatamab can improve progression-free survival in this patient group. Participants receive an initial lower dose of tarlatamab on the first day of the first treatment cycle, followed by the full dose on days 8 and 15 of the first cycle, and then on days 1 and 15 of each subsequent cycle. All participants are treated with tarlatamab; there is no placebo group. Treatment continues under this schedule for the duration of the study. Throughout the trial, participants will undergo screening and monitoring including imaging to confirm metastatic disease, laboratory testing to assess organ function, and evaluations to measure disease progression and response. The primary outcome measured is progression-free survival up to 24 weeks. Secondary outcomes include overall response rate during the same period. Safety and eligibility will be carefully monitored before and during treatment, with participation lasting according to treatment response and study timelines.
CONDITIONS
Brief 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 and privacy authorization
- 18 years of age and older
- Resting oxygen saturation of 90% or higher on room air
- Histologically confirmed prostate cancer of any subtype
- Documented metastatic disease by CT, MRI, or bone scan (not PET only)
- Serum testosterone 50 ng/dL or less with ongoing androgen-deprivation therapy or de novo small cell NEPC
- Progression on at least one prior line of metastatic therapy based on PSA rise, RECIST 1.1 criteria, or new bone lesions
- For de novo small cell NEPC, prior platinum chemotherapy received or ineligible
- No more than two prior lines of cytotoxic chemotherapy for metastatic disease
- DLL3 positive disease confirmed by biopsy with 50% or more tumor cells expressing DLL3
- Brain metastases allowed if treated and stable with no steroids or progression
- ECOG performance status of 2 or less
- Normal organ function with acceptable lab values within 14 days of treatment start
- Agreement to use medically acceptable birth control or sexual abstinence during and 60 days after study
- Female partners must use contraception unless postmenopausal or abstinent
You will not qualify if you...
- Any prior or current malignancy that may interfere with safety or efficacy assessments
- Uncontrolled hypertension or recent major cardiovascular events within 6 months
- History of seizure or NYHA class III or higher heart failure
- Active hepatitis B or C infection
- Active HIV infection with detectable viral load
- History of leptomeningeal disease
- Active autoimmune disease requiring systemic treatment within 2 years or significant autoimmune adverse effects
- History of interstitial lung disease or grade 2 or higher pneumonitis
- Diagnosis of immunodeficiency or recent systemic steroid use above 10 mg/day
- Infection requiring intravenous antibiotics within 7 days of treatment
- Prior DLL3-targeting therapy
- Recent systemic anti-cancer treatment or investigational agents within 14 days
- Major surgery within 28 days prior to treatment
- Palliative radiotherapy less than 1 week prior to treatment
- Use of prohibited medications with potential drug interactions within 2 weeks
- Ongoing grade 2 or higher treatment-related adverse events
- Known allergy to study compounds
- Any other condition that would preclude participation in the investigator's opinion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks
Participants receive a lower dose of tarlatamab on Cycle 1 Day 1 followed by the full dose on Cycle 1 Days 8 and 15 and on Days 1 and 15 of subsequent cycles.
Visits on Cycle 1 Days 1, 8, 15 and Days 1 and 15 of subsequent cycles
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
M
Michael Morris, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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