Tarlatamab for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if tarlatamab, an experimental treatment, can effectively treat prostate cancer that tests positive for DLL3, a specific protein, and has metastasized. It targets cases where the cancer has recurred after treatment or did not respond initially. Ideal participants have confirmed prostate cancer that has spread and progressed despite previous treatment. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.
Do I have to stop taking my current medications for the trial?
The trial protocol does not clearly specify if you need to stop taking your current medications. However, you cannot use any medications that might interact with the study drug within two weeks before starting the trial. It's best to discuss your current medications with the trial team to ensure they are not on the prohibited list.
Is there any evidence suggesting that tarlatamab is likely to be safe for humans?
Research has shown that tarlatamab appears safe for humans. Earlier studies provided initial evidence of its safety in treating DLL3-positive neuroendocrine prostate cancer. These studies suggest that most patients tolerate the treatment well.
However, it is important to note that this is a Phase 2 trial. While early signs of safety have emerged from past research, the treatment remains under investigation. Participants might experience side effects, and researchers continue to learn more about these as the trial progresses.
Prospective participants should discuss potential risks and benefits with their healthcare provider, who can offer advice based on individual circumstances.12345Why do researchers think this study treatment might be promising for prostate cancer?
Unlike the standard treatments for prostate cancer, which often include hormone therapy, chemotherapy, or radiation, Tarlatamab offers a novel approach by utilizing a new mechanism of action. Tarlatamab is a bispecific T-cell engager (BiTE) that targets both the cancer cells and T-cells, potentially directing the body's immune system to more effectively attack the cancer. Researchers are excited because this targeted action could lead to more precise elimination of cancer cells with potentially fewer side effects. This innovative approach represents a promising shift in how prostate cancer might be treated in the future.
What evidence suggests that tarlatamab might be an effective treatment for prostate cancer?
Research has shown that tarlatamab, which participants in this trial will receive, may help treat DLL3-positive prostate cancer. In one study, 22.2% of patients with this tumor type experienced tumor shrinkage, while none with other tumor types did. Tarlatamab also showed early signs of safety for patients. These findings suggest that tarlatamab could be a promising treatment option for this specific kind of prostate cancer.12367
Who Is on the Research Team?
Karen Autio, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
This trial is for individuals with prostate cancer that has spread and isn't responding to treatment or has returned after treatment. Participants must have a specific protein called DLL3 in their tumors.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive tarlatamab with a lower dose on Cycle 1 Day 1, followed by the full dose on Cycle 1 days 8, 15, and days 1 and 15 for all subsequent cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Tarlatamab
Trial Overview
The study is testing the effectiveness of a new medication named Tarlatamab on patients with advanced, DLL3-positive prostate cancer to see if it can control the disease's progression.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants 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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Amgen
Industry Sponsor
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London
Citations
Results from the Phase 1b DeLLpro-300 Study
Patients with DLL3+ tumors (vs patients with DLL3-/DLL3 unknown tumors) acheived a higher ORR (22.2% [95% CI, 6.4-47.6] vs 0% [95% CI, 0-15.4]) ...
2.
aacrjournals.org
aacrjournals.org/clincancerres/article/doi/10.1158/1078-0432.CCR-25-1211/763701/Safety-and-Efficacy-of-Tarlatamab-in-patients-with?searchresult=1Safety and Efficacy of Tarlatamab in Patients with ...
The DeLLpro-300 study provides preliminary evidence for the safety and antitumor activity of tarlatamab in DLL3+ NEPC. Translational Relevance.
3.
onclive.com
onclive.com/view/tarlatamab-demonstrates-early-safety-and-activity-in-dll3-neuroendocrine-prostate-cancerTarlatamab Demonstrates Early Safety and Activity in ...
Tarlatamab showed a 10.5% objective response rate in NEPC, with better outcomes in DLL3-positive tumors, achieving a 22.2% response rate. Common ...
Phase 1b study of tarlatamab in de novo or treatment ...
Results: As of 28 March 2023, 40 pts received ≥1 tarlatamab dose (1 mg step dose, 100 mg target dose). Median (range) age was 64.5 (43–83) y, ...
Results from the Phase 1b DeLLpro-300 Study.
Patients with DLL3+ tumors (vs patients with DLL3-/DLL3 unknown tumors) acheived a higher ORR (22.2% [95% CI, 6.4-47.6] vs 0% [95% CI, 0-15.4]) ...
6.
clinicaltrials.gov
clinicaltrials.gov/study/NCT06893783?cond=Pancreatic+Cancer&aggFilters=status%3AEfficacy and Safety Evaluation of Tarlatamab in Advanced ...
This is a phase 2 single-arm, open-label clinical trial designed to evaluate the efficacy and safety of tarlatamab in patients with relapsed extrapulmonary ...
Phase 1b study of tarlatamab in de novo or treatment ...
This is an open-label phase 1b study evaluating tarlatamab monotherapy in adult (≥18 years [y]) pts with metastatic de novo or treatment-emergent NEPC.
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