A Study of Tarlatamab for People With Prostate Cancer
ConditionMetastatic Prostate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Tarlatamab
DrugPatients 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.
Treatment groups
32 Participants
are divided into 1 treatment groupGroup A: TarlatamabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
up to 24 weeksSecondary outcomes
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.
Time frame
up to 24 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Memorial Sloan Kettering Cancer Center
Lead sponsor
Amgen
Collaborator
Source ClinicalTrials.gov