Tarlatamab for Prostate Cancer

Recruiting at 6 trial locations

Overseen By Karen Autio, MD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: Androgen deprivation

Must not be taking: Antivirals, Immunosuppressants

Disqualifiers: Uncontrolled hypertension, Seizure history, Active hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

32 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 2 3 6 7}

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

Willing and able to provide written informed consent and privacy authorization for the release of personal health information

I am 18 years old or older.

My prostate cancer diagnosis was confirmed through a tissue examination.

Exclusion Criteria

I have had cancer spread to the lining of my brain and spinal cord.

Receipt of another investigational therapeutic agent within 14 days prior to C1D1

I haven't had any cancer treatments in the last 14 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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?

Group I: Tarlatamab Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Amgen

Industry Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

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

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40689871/

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=1

Safety 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-cancer

Tarlatamab 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 ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.5012

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, ...

5. urotoday.com urotoday.com/recent-abstracts/urologic-oncology/prostate-cancer/162068-safety-and-efficacy-of-tarlatamab-in-patients-with-neuroendocrine-prostate-cancer-results-from-the-phase-1b-dellpro-300-study.html

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%3A

Efficacy 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 ...

7. asco.org asco.org/abstracts-presentations/ABSTRACT465812

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.