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Monoclonal Antibodies
Tarlatamab for Prostate Cancer (DeLLpro-300 Trial)
Phase 1
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 per Prostate Cancer Working Group 3 (PCWG3) modifications
For participants with treatment-emergent NEPC or de novo NEPC with histologic evidence of prostate cancer with neuroendocrine differentiation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 months
Awards & highlights
DeLLpro-300 Trial Summary
This trial is testing a new cancer drug to see if it is safe and how well it works.
Who is the study for?
This trial is for men over 18 with advanced prostate cancer showing neuroendocrine features, who've had at least one prior systemic treatment. They must have measurable disease, be in fairly good health (ECOG ≤2), and have proper organ function. Men on hormone therapy must continue it during the study. Those with untreated brain metastases or certain other conditions are excluded.Check my eligibility
What is being tested?
The trial is testing Tarlatamab to find out how safe it is and what dose can be given without causing severe side effects. It aims to establish the maximum tolerated dose or a recommended dose for future Phase 2 trials.See study design
What are the potential side effects?
Potential side effects of Tarlatamab may include typical reactions seen with cancer treatments such as fatigue, nausea, inflammation in organs like lungs (pneumonitis), immune system complications, and possibly others that will be monitored.
DeLLpro-300 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer can be measured by specific medical criteria.
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My prostate cancer has shown signs of turning into neuroendocrine cancer.
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I can take care of myself but might not be able to do heavy physical work.
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My prostate cancer has spread and shows specific markers.
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I have a specific type of prostate cancer and haven't had both testicles removed. I'm on hormone therapy.
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I am a man aged 18 or older.
DeLLpro-300 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants who Experience Dose Limiting Toxicities (DLTs)
Number of Participants who Experience One or More Treatment-emergent Adverse Events (TEAEs)
Number of Participants who Experience One or More Treatment-related Adverse Events
+3 moreSecondary outcome measures
Accumulation Ratio of Tarlatamab
Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of Tarlatamab
Disease Control Rate (DCR)
+7 moreDeLLpro-300 Trial Design
2Treatment groups
Experimental Treatment
Group I: Part 2: Dose ExpansionExperimental Treatment1 Intervention
Participants will receive the RP2D/MTD identified in Part 1 (dose exploration) of the study.
Group II: Part 1: Dose ExplorationExperimental Treatment1 Intervention
The maximum tolerated dose (MTD) will be estimated using isotonic regression (Ji et al, 2010). The recommended phase 2 dose (RP2D) may be identified based on emerging safety data prior to reaching an MTD.
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Who is running the clinical trial?
AmgenLead Sponsor
1,382 Previous Clinical Trials
1,379,642 Total Patients Enrolled
13 Trials studying Prostate Cancer
4,844 Patients Enrolled for Prostate Cancer
MDStudy DirectorAmgen
928 Previous Clinical Trials
926,689 Total Patients Enrolled
8 Trials studying Prostate Cancer
4,749 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had cancer treatment in the last 28 days, but I may be on hormone therapy for prostate cancer or stable bone medication.I have brain metastases or leptomeningeal disease that hasn't been treated or is causing symptoms.I have had treatment for brain metastases and meet specific criteria.My cancer was treated with the goal of cure, and I've been cancer-free for over 2 years.I have received at least one round of systemic treatment.My prostate cancer can be measured by specific medical criteria.My prostate cancer has shown signs of turning into neuroendocrine cancer.I finished any palliative radiotherapy at least a week ago.My organs are functioning well.I can take care of myself but might not be able to do heavy physical work.My side effects from previous cancer treatments are mild or well-managed, except for hair loss.I had COVID-19 but have been symptom-free for at least 14 days.I have had issues with my pituitary gland.There are some special cases where the criteria may not apply.I took androgen signaling inhibitors, and it's been over 14 days with minimal side effects.I have not needed treatment for an autoimmune disease in the last 2 years.I have a lung condition not caused by an infection.I had skin cancer (not melanoma) treated and currently show no signs of it.My bladder cancer was treated and did not spread into the muscle.I had blood cancer but have been free of it for over 2 years.It's been over 2 weeks since my last chemotherapy, and any side effects are mild.I have not taken steroids or immunosuppressants in the last 7 days.My prostate cancer has spread and shows specific markers.I have a specific type of prostate cancer and haven't had both testicles removed. I'm on hormone therapy.I have had cancer other than my current one in the last 2 years.I am a man aged 18 or older.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1: Dose Exploration
- Group 2: Part 2: Dose Expansion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have been enlisted in this medical experiment?
"To complete this trial, 60 participants that meet the pre-defined requirements are necessary. The study can be joined from Wake Forest Baptist Health in Winston-Salem and Washington University in Saint Louis."
Answered by AI
Is enrollment for this experimentation open to the public?
"At present, the clinical trial is actively recruiting; it was first posted on June 10th 2021 and last edited August 11th 2022."
Answered by AI
Has the FDA granted its seal of approval to AMG 757?
"As this is a Phase 1 trial, and thus possesses limited data confirming its safety or efficacy, AMG 757 was assigned a score of 1."
Answered by AI
What criteria must a patient meet in order to be considered for participation in this clinical trial?
"This clinical trial seeks to enrol 60 individuals who are aged between 18 and 65, and have a diagnosis of prostate cancer. Furthermore, these patients must meet the following conditions: providing informed consent; having undergone at least one prior systemic treatment; exhibiting measurable disease according to RECIST 1.1 with PCWG3 modifications; displaying an ECOG Performance Status of 2 or lower; not suffering from untreated brain metastases (if present); and demonstrating adequate organ function as per protocol standards."
Answered by AI
Is the participant base of this trial restricted to those aged 80 and below?
"This research initiative is looking for participants aged 18 - 65."
Answered by AI
At what number of medical facilities is this trial currently being conducted?
"There are 10 different medical facilities participating in this clinical trial, for example Wake Forest Baptist Health located in Winston-Salem, Washington University situated in Saint Louis and the University of Chicago based out of Chicago."
Answered by AI
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