BridgeMD
New treatment option for Metastatic Prostate Cancer
Official title A Study of Tarlatamab for People With Prostate Cancer
ClinicalTrials.gov ID: NCT07111507
What this study is testing
What is Tarlatamab?
Tarlatamab is an investigational medicine, being studied as a potential treatment for metastatic prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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...
- 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.
You likely can't join if
- Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works assessments...
- Medical conditions such as uncontrolled hypertension (sustained SBP \> 160 mm Hg or diastolic BP \> 100 mm Hg), any history of seizure, or major...
- 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)...
- 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...
See the full eligibility criteria
Who can 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...
- 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...
- 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...
- 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...
- 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...
- 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...
What rules you out
- Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
- San Francisco, California, United States
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Diego, California, United States; San Francisco, California, United States; Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.