What side effects are associated with this type of intervention?

Common treatments for prostate cancer, particularly targeted radiotherapy using PSMA-specific agents like Lutetium-177 or Thorium-227 labeled immuno-conjugates, often result in side effects such as bone marrow suppression, leading to conditions like anemia, thrombocytopenia, and leukopenia. Patients may also experience fatigue, nausea, and dry mouth. Serious adverse events can include high-grade bone marrow suppression and, in rare cases, myelodysplastic syndrome. These treatments are generally well-tolerated, but close monitoring for hematologic toxicities is essential.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer that utilize targeted radiotherapy and PSMA-specific mechanisms. One notable example is lutetium Lu 177 vipivotide tetraxetan, a radioligand therapy targeting PSMA, which has shown efficacy in patients with metastatic castration-resistant prostate cancer (CRPC). This treatment has demonstrated significant improvements in progression-free survival and overall survival in clinical trials. Additionally, radium-223 dichloride (Ra-223) is another radiopharmaceutical approved for CRPC that targets bone metastases, providing a survival benefit and pain relief. These approvals highlight the potential of targeted radiotherapy in managing advanced prostate cancer.

What other types of research exist?

Promising novel alternatives to BAY 2315497 Injection for prostate cancer treatment include: <ol> <li>149Tb-PSMA-617: This targeted alpha-therapy (TAT) has shown high radiochemical purity and effectiveness in preclinical models of PSMA-expressing prostate cancer.</li> <li>177Lu-PSMA-617: This radiolabeled small molecule binds with high affinity to PSMA, enabling targeted radiation therapy to metastatic prostate lesions and has shown promising results in clinical settings.</li> <li>177Lu-HTK01169: An albumin-binder-conjugated derivative of 177Lu-PSMA-617, designed to extend blood retention time and maximize radiation dose to prostate tumors.</li> <li>Ra-223 plus abiraterone or enzalutamide: This combination has shown improved survival and durable decreases in serum tumor markers in clinical studies, although it remains experimental.</li> <li></li> </ol> Sipuleucel-T plus Ra-223: Preliminary reports suggest this combination may improve disease regression without enhancing toxicity, though more data is needed.

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Monoclonal Antibodies

Thorium-227 Conjugate + Darolutamide for Prostate Cancer

Phase 1

Waitlist Available

Research Sponsored by Bayer

Eligibility Criteria Checklist

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

Must have

Documented progression of mCRPC, as defined according to the Prostate Cancer Working Group 3 (PCWG3) guidelines

Male adult patients (≥ 18 years of age)

Must not have

Previous high-dose chemotherapy, needing hemopoietic stem cell rescue, is prohibited

Known human immunodeficiency virus (HIV) infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 cycles (each cycle is 42 days, a maximum of 3 additional treatment cycles may be administered in case a favorable benefit risk profile is documented)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new injection that targets and kills prostate cancer cells in patients whose cancer has spread and does not respond to standard treatments. The injection uses a radioactive substance to directly attack the cancer cells.

Who is the study for?

This trial is for adult males with advanced prostate cancer that has resisted castration treatment and progressed despite hormone therapy. Participants must have had prior treatments, be in good physical condition (ECOG PS of 0 or 1), and expect to live at least another six months. They should not have other active cancers or serious heart conditions, infections, or immune deficiencies.

What is being tested?

The study tests a new drug called BAY2315497 Injection targeting prostate cancer cells, alone or with Darolutamide. It aims to find the safest dose with tolerable side effects (Maximal Tolerated Dose) and how the body processes these drugs.

What are the potential side effects?

Potential side effects may include reactions related to radiation exposure since BAY2315497 includes thorium-227. Other risks could involve typical chemotherapy-related issues like fatigue, nausea, blood cell count changes, and increased infection risk.

Eligibility Criteria

Inclusion Criteria

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

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My prostate cancer has worsened despite treatment.

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I am a man aged 18 or older.

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I am fully active or can carry out light work.

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I have been treated with a drug like enzalutamide or abiraterone.

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My prostate cancer is confirmed without specific aggressive features.

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

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My blood, liver, and kidney tests meet the required levels.

Exclusion Criteria

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

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I have not had high-dose chemotherapy requiring stem cell support.

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I am HIV positive.

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I have a history of or signs suggesting myelodysplastic syndrome or leukemia.

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I am not allergic to the study drug or any imaging contrast agents.

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I have a stomach or intestine condition that affects how my body absorbs medicine.

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I am currently being treated for active hepatitis B or C.

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I have a serious heart condition.

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I do not have a serious infection.

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I have a serious wound or broken bone that is not healing.

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I have been treated with radium-223 or similar radioactive drugs.

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I finished my radiotherapy less than 6 weeks ago.

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I have been treated with PSMA-targeted therapy before.

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I cannot swallow pills.

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I do not have spinal cord compression or brain metastases.

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I haven't had a different cancer in the last 2 years.

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My cancer has spread extensively to my bones or bone marrow.

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I am sensitive to radiation due to my genetics.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 cycles (each cycle is 42 days, a maximum of 3 additional treatment cycles may be administered in case a favorable benefit risk profile is documented)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 cycles (each cycle is 42 days, a maximum of 3 additional treatment cycles may be administered in case a favorable benefit risk profile is documented)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 cycles (each cycle is 42 days, a maximum of 3 additional treatment cycles may be administered in case a favorable benefit risk profile is documented) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Maximum tolerated dose (MTD) of BAY2315497 injection

Maximum tolerated dose (MTD) of BAY2315497 injection in combination with darolutamide

Secondary study objectives

Recommended dose for further clinical development of BAY2315497 injection

Recommended dose for further clinical development of BAY2315497 injection in combination with darolutamide

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: BAY2315497 dose expansion:Dose regimen 2Experimental Treatment1 Intervention

The thorium-227 and total antibody doses, as well as the treatment regimen, will be selected for expansion on the basis of the safety, PK and overall benefit risk profile of BAY2315497 Injection, observed in the course of the dose escalation.

Group II: BAY2315497 dose expansion:Dose regimen 1Experimental Treatment1 Intervention

Group III: BAY2315497 dose escalation in combination with darolutamideExperimental Treatment2 Interventions

The thorium-227 dose will be escalated in a step-wise fashion to the MTD, according to a predefined dose escalation scheme. In addition, Darolutamide oral dosing at the approved dose of twice daily 600 mg will be initiated 14 days prior to the first BAY2315497 Injection dose on Day 1 of the first cycle. Daily darolutamide dosing will continue throughout the entire BAY2315497 Injection treatment period until withdrawal criteria from study treatment period are met.

Group IV: BAY2315497 dose escalationExperimental Treatment1 Intervention

The thorium-227 dose will be escalated in a step-wise fashion to the MTD, according to a predefined dose escalation scheme. The total antibody dose of 50 mg will be evaluated first; on the basis of emerging clinical data, doses within the range of 20-100 mg may be investigated.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Darolutamide(BAY1841788)

2018

Completed Phase 1

~70

BAY2315497 Injection

2018

Completed Phase 1

~70

0 / 24Eligibility 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

Prostate cancer treatments often target specific mechanisms to inhibit cancer growth and spread. Androgen deprivation therapy (ADT) reduces androgen levels, which prostate cancer cells rely on for growth. Chemotherapy, such as docetaxel, kills rapidly dividing cells, including cancer cells. Targeted radiotherapy, like the PSMA-specific thorium-227 labeled immuno-conjugate (BAY 2315497), delivers radiation directly to prostate cancer cells expressing PSMA, minimizing damage to surrounding healthy tissue. This targeted approach is crucial for prostate cancer patients as it offers a more precise treatment, potentially reducing side effects and improving outcomes.