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Radioisotope Therapy

BAY3546828 for Prostate Cancer

Phase 1

Recruiting

Research Sponsored by Bayer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presence of at least one Prostate-specific membrane antigen (PSMA)-positive distant metastatic lesion on the screening PSMA PET/CT scan

Documented progressive mCRPC per PCWG3 criteria

Must not have

Prior definitive therapy completed less than 6 weeks before study intervention

Participants with specific tumor lesions that are PSMA negative and meet size criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months after end of treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for men with advanced prostate cancer that has spread to other parts of the body and is not responding to current treatments. The treatment, called 225Ac-pelgi

Who is the study for?

This trial is for men with advanced metastatic castration-resistant prostate cancer (mCRPC) who have tried other treatments or have limited options. They must have a specific type of prostate cancer, confirmed by tests, and treated previously with certain drugs like enzalutamide or abiraterone. Participants need to maintain low testosterone levels through treatment or surgery and should be physically able to perform daily activities with minimal assistance.

What is being tested?

The study is testing the safety and effectiveness of a new treatment called Actinium-225-macropa-pelgifatamab (BAY3546828). It targets a protein on cancer cells to deliver radiation directly to them. The trial has two parts: finding the best dose and then giving that dose over four cycles every six weeks if beneficial. Researchers will monitor participants' health, take samples, use imaging techniques, and ask about their wellbeing.

What are the potential side effects?

Potential side effects are not explicitly listed in the provided information but may include typical reactions related to radiotherapy such as fatigue, nausea, hair loss at targeted sites, skin irritation where radiation is applied, decreased blood cell counts leading to increased infection risk or bleeding tendencies.

Eligibility Criteria

Inclusion Criteria

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

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My scans show at least one PSMA-positive spot away from my prostate.

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My prostate cancer is worsening despite treatment.

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My prostate cancer is advanced and does not have small-cell or neuroendocrine features.

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I have undergone orchiectomy or am on hormone therapy with low testosterone levels.

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I have been treated with a drug targeting the androgen pathway.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

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

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I finished my last cancer treatment less than 6 weeks ago.

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My tumor does not show PSMA and meets the size criteria.

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I have previously received treatment with actinium-225.

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I have experienced side effects from cancer treatment that are moderate to severe.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months after end of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months after end of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months after end of treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Dose escalation: Incidence of dose limiting toxicities (DLTs) at each 225Ac dose level during the DLT observation period

Dose escalation: Objective response rate (ORR) at each 225Ac dose level during the DLT observation period

Dose escalation: ≥50% decline in Prostate-specific antigen value from baseline (Cycle 1, Day 1) (PSA50) response at each 225Ac dose level during the DLT observation period

Secondary study objectives

Dose escalation & Dose expansion: Duration of PSA50 response

Dose escalation & Dose expansion: Duration of response (DOR) by PCWG3 based on investigator review

Dose escalation & Dose expansion: Radiologic progression-free survival (rPFS ) by PCWG3 based on investigator review

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Dose expansion group C of BAY3546828Experimental Treatment1 Intervention

Participants with advanced mCRPC after prior Lutetium-177 labeled PSMA ligand (177Lu-PSMA) treatment.

Group II: Dose expansion group B of BAY3546828Experimental Treatment1 Intervention

Participants with advanced mCRPC who have not received taxane chemotherapy since becoming castration-resistant. No prior radionuclide therapy.

Group III: Dose expansion group A of BAY3546828Experimental Treatment1 Intervention

Participants with advanced mCRPC with at least 1 but no more than 2 prior taxane regimens. No prior radionuclide therapy

Group IV: Dose escalation of BAY3546828Experimental Treatment1 Intervention

Participants with advanced metastatic castration-resistant prostate cancer (mCRPC) will receive 225Ac-pelgi dose in a stepwise fashion, according to a predefined dose escalation scheme.

0 / 10Eligibility criteria met