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Radioantibody

Ac-225 Rosopatamab Tetraxetan for Prostate Cancer

Phase 2
Recruiting
Research Sponsored by Convergent Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Progression following treatment with ADT and at least one ARSI
Prior treatment with one taxane-based chemotherapy allowed
Must not have
Superscans by nuclear medicine/99mTc bone scan
Prior PARP inhibitors
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial is looking at a new treatment for prostate cancer that uses a radioantibody to target cancer cells. The study is divided into three parts. In Part 1, participants will receive an

Who is the study for?
This trial is for individuals with PSMA PET-positive castration-resistant prostate cancer. Participants must have a specific type of advanced prostate cancer and may be sorted into different parts of the study based on their previous treatments. Those who've had Lu-177-PSMA therapy go to Part 3, while others may enter Part 2.
What is being tested?
The study tests a radioantibody called rosopatamab tetraxetan, linked to radioactive elements In-111 or Ac-225. It's given in varying doses to see how well it targets cancer cells and what dose is best tolerated. The trial includes initial dosimetry, randomized dose optimization between two levels (55 or 60 KBq/kg), and dose escalation starting at 45 KBq/kg.
What are the potential side effects?
Potential side effects include reactions related to radiation exposure such as nausea, fatigue, blood cell count changes leading to increased infection risk or bleeding problems, kidney damage, and possibly other organ-specific issues due to the targeted nature of the treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer progressed after hormone therapy and at least one ARSI treatment.
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I have had one taxane-based chemotherapy treatment.
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My prostate cancer is worsening despite low testosterone levels.
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My cancer has spread to other parts of my body, confirmed by imaging tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My bone scan shows extensive cancer spread.
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I have never taken PARP inhibitors before.
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I have not had any cancer, besides prostate cancer, needing treatment in the last 3 years.
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I have received platinum-based chemotherapy before.
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I have had radiopharmaceutical therapy before.
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I have previously received PSMA-targeted therapy.
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I stopped my prostate cancer chemotherapy over a year ago.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

4Treatment groups
Experimental Treatment
Group I: Part 3: Dose EscalationExperimental Treatment3 Interventions
Participants previously treated with Lu-177-PSMA-radioligand therapy will be assigned to receive one of the three dose levels (45 KBq/kg, 55 KBq/kg, or 60 KBq/kg) depending on the dose limiting toxicities (DLTs) observed.
Group II: Part 2: 60 KBq/kg Ac-225 rosopatamab tetraxetanExperimental Treatment1 Intervention
Group III: Part 2: 55 KBq/kg Ac-225 rosopatamab tetraxetanExperimental Treatment1 Intervention
Group IV: Part 1: 148 ± 37 MBq In-111 rosopatamab tetraxetanExperimental Treatment1 Intervention

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Who is running the clinical trial?

Convergent TherapeuticsLead Sponsor
~31 spots leftby Dec 2025
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