What side effects are associated with this type of intervention?

Common treatments for prostate cancer, including androgen receptor inhibitors like darolutamide, enzalutamide, and apalutamide, as well as chemotherapy agents like docetaxel and cabazitaxel, have various side effects. Androgen receptor inhibitors can cause fatigue, hypertension, and an increased risk of seizures (notably lower with darolutamide). Chemotherapy agents often lead to neutropenia, diarrhea, infection, and fatigue. Abiraterone, another common treatment, can cause fluid retention, hypokalemia, and hypertension. These side effects are important considerations when evaluating the safety and tolerability of new treatments like Tarlatamab.

What prior FDA approvals exist?

Several treatments for prostate cancer have received FDA approval, particularly for advanced or metastatic castration-resistant prostate cancer (CRPC). These include androgen receptor inhibitors like enzalutamide, apalutamide, and darolutamide, which block androgen receptor signaling. Additionally, PARP inhibitors such as rucaparib and niraparib are approved for patients with specific genetic mutations. Radium-223 is a radiopharmaceutical used for bone metastases. Immunotherapy options include sipuleucel-T, a dendritic cell vaccine, and pembrolizumab for tumors with specific genetic markers. These treatments focus on different mechanisms to control cancer progression and improve patient outcomes.

What other types of research exist?

Promising novel alternatives to Tarlatamab for prostate cancer patients in 2024 include PARP inhibitors such as Niraparib, Olaparib, Rucaparib, and Talazoparib, especially in combination with androgen receptor targeting agents.

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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.

Must not have

Untreated or symptomatic brain metastases and leptomeningeal disease

History of hypophysitis or pituitary dysfunction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called Tarlatamab to see if it is safe for people to use. The goal is to find out the best dose to give. The study will help determine if Tarlatamab can be a good treatment option for patients who need new therapies.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have brain metastases or leptomeningeal disease that hasn't been treated or is causing symptoms.

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I have had issues with my pituitary gland.

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I have a lung condition not caused by an infection.

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I had skin cancer (not melanoma) treated and currently show no signs of it.

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I have not taken steroids or immunosuppressants in the last 7 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Objective Response (OR)

Side effects data

From 2024 Phase 1 trial • 23 Patients • NCT04885998

40%

Urinary tract infection

40%

Hypokalaemia

40%

Fatigue

40%

COVID-19

40%

Weight decreased

40%

Anaemia

40%

Pyrexia

40%

Nausea

20%

Sepsis

20%

Skin infection

20%

Aspartate aminotransferase increased

20%

Platelet count decreased

20%

Decreased appetite

20%

Brain fog

20%

Hyperglycaemia

20%

Hypertension

20%

Neutrophil count decreased

20%

Restless legs syndrome

20%

Small cell lung cancer

20%

Sinus tachycardia

20%

Constipation

20%

Bone pain

20%

Alanine aminotransferase increased

20%

Cytokine release syndrome

20%

Blindness

20%

Rhinovirus infection

20%

Hyponatraemia

20%

Arthralgia

20%

Akathisia

20%

Headache

20%

Paraesthesia

20%

Ecchymosis

20%

Hypotension

20%

Myalgia

20%

Pruritus

20%

Vomiting

20%

Memory impairment

20%

Cataract

20%

Encephalopathy

20%

Dysarthria

20%

Delirium

20%

Depression

100%

80%

60%

40%

20%

Study treatment Arm

Part 1 Cohort 2: Tarlatamab Dose A/Dose C + AMG 404 (SFU1)

Part 2 Dose Expansion Cohort: Tarlatamab Dose B + AMG 404 (SFU1)

Part 1 Cohort 1: Tarlatamab Dose A/Dose B + AMG 404 (SFU1)

Part 1 Cohort 1: Tarlatamab Dose A/Dose B + AMG 404 (EP)

Part 1 Cohort 3: Tarlatamab Dose A/ Dose D + AMG 404 (EP)

Part 2 Dose Expansion Cohort: Tarlatamab Dose B + AMG 404 (EP)

Part 1 Cohort 2: Tarlatamab Dose A/Dose C + AMG 404 (EP)

Part 1 Cohort 3: Tarlatamab Dose A/ Dose D + AMG 404 (SFU1)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tarlatamab

2021

Completed Phase 1

~70

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for prostate cancer include androgen receptor antagonists like enzalutamide, apalutamide, and darolutamide, which block the binding of androgens to their receptors, inhibiting cancer cell growth. Immunotherapies, such as PD-1 inhibitors like pembrolizumab, enhance the immune system's ability to target and destroy cancer cells. These treatments are crucial as they offer targeted approaches to slow disease progression and improve survival rates, especially in advanced stages of prostate cancer.

Impact of darolutamide on local symptoms: pre-planned and post hoc analyses of the ARAMIS trial.