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PSMA PET-Positive Castration-Resistant Prostate CancerPhase 2NCT06549465

Study Evaluating Dosimetry, Randomized Dose Optimization, Dose Escalation and Efficacy of Ac-225 Rosopatamab Tetraxetan in Participants With PSMA PET-Positive Castration-Resistant Prostate Cancer (CRPC)

A Phase 2 study testing In-111 rosopatamab tetraxetan, 45 kBq/kg Ac-225 rosopatamab tetraxetan and 45 kBq/kg or equivalent fixed dose activity Ac-225 rosopatamab tetraxetan in people with PSMA PET-Positive Castration-Resistant Prostate Cancer, run by Convergent Therapeutics at 9 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a four-part study evaluating the safety and efficacy of a PSMA-directed radioantibody (rosopatamab tetraxetan, conjugated to either In-111 or Ac-225). Part 1 will consist of one administration of In-111-rosopatamab tetraxetan to characterize the biodistribution of the radioantibody to target organs and… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
In-111 rosopatamab tetraxetan, 45 kBq/kg Ac-225 rosopatamab tetraxetan and 45 kBq/kg or equivalent fixed dose activity Ac-225 rosopatamab tetraxetan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
9 sitesUnited States
Study dates
6 Aug 2024to Oct 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Progressive CRPC defined as castrate levels of testosterone and progressing by at least one of the following criteria:
  • Serum PSA progression as defined by PCWG3 (rising PSA consisting of two consecutive increases measured at least 3 weeks apart, of a rise of >25%, and with an absolute rise of 2.0 ng/mL.
  • Soft tissue progression defined as a ≥20% increase in the sum of the diameter (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest sum of the diameter since the previous treatment was started or the appearance of one or more new lesions by CT/magnetic resonance imaging (MRI)
  • Progression of bone disease defined by PCWG3 as evaluable disease or new bone lesions by bone scan
  • Identification of new soft tissue or bone lesions on PSMA PET imaging
  • Metastatic disease defined as either or both of the following:
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  • Parts 1, 2, 3, and 4: Documented M1 disease on conventional imaging (CT/MRI of the chest/abdomen/pelvis and/or Technetium 99m [99mTc] whole-body bone scan)
  • Parts 1, 2, and 4 only: Identification of bone lesion(s), extra-pelvic soft tissue lesion(s), or visceral metastases on PSMA PET imaging with an FDA-approved imaging agent
  • PSMA PET-positive disease, defined as at least one PSMA-positive metastatic lesion and no PSMA-negative lesions
  • Progression following treatment with ADT and at least one ARSI (e.g., enzalutamide, apalutamide, darolutamide, and/or abiraterone acetate)
  • The standard of care use (in the setting of metastatic CRPC with significant burden of active bone metastases) of antiresorptive bone-targeted agents (e.g., zoledronic acid, denosumab) is required for all participants without a contraindication, for at least 4 weeks prior to administration of Ac-225 rosopatamab tetraxetan.
  • Participants with HIV are eligible if they are well-controlled (i.e, an undetectable HIV viral load (<50 copies/mL) within 6 months of enrollment and a stable ART regimen for at least 6 months prior to enrollment) and at low risk for HIV-related illness
  • Part 3 Only:
  • Prior treatment with Lu-177-PSMA-radioligand therapy
  • Prior treatment with up to only one taxane-based chemotherapy regimen is allowed

Who cannot join

  • Superscans by nuclear medicine/99mTc bone scan
  • A known malignancy that is progressing or has required active treatment within the past 3 years other than CRPC, which is expected to alter life expectancy or may interfere with CRPC disease assessment
  • Prior platinum-based chemotherapy
  • Prior PARP inhibitors (e.g., olaparib or rucaparib)
  • Prior treatment with Radium-223, Actinium-225, Strontium-89, Samarium-153, Rheunium-186, or Rhenium-188
  • Participants receiving anti-coagulants or anti-platelet drugs (e.g., aspirin or nonsteroidal anti-inflammatory drugs [NSAIDs]) who cannot discontinue use if platelet count decreases to <50,000
Show all 12Show fewer
  • Part 2 and 4 Only:
  • Prior chemotherapy for CRPC. Prior taxane chemotherapy for HSPC is allowed if discontinued ≥1 year prior to randomization
  • Prior radiopharmaceutical therapy (e.g., Ra-223, Lu-177-PSMA-617, or Lu-177-PSMA-I\&T)
  • Prior PSMA-targeted therapy, except for bispecific or CAR-T therapies
  • Part 3 Only:
  • Prior PSMA-targeted therapy (e.g., antibody-drug conjugates or CAR-T therapy), except for Lu-177-PSMA-radioligand therapy and bispecific or CAR-T therapies

Trial locations and contacts

9 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Study Director contact

CONVERGE01

CONVERGE01@convergentrx.com

9 sites in 1 country

United States9 sites, 8 recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Praful Ravi, MB, BChir, MRCP

    Recruiting

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

    Shilpa Gupta, MD

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Daniel George, MD

    Recruiting

  • Laura & Isaac Perlmutter Cancer Center

    New York, New York, 10016

    David Wise, MD

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Anis Hamid, MD

    Recruiting

  • New York Presbyterian/Weill Cornell Medical Center

    New York, New York, 10065

    Cora Sternberg, MD

    Recruiting

  • X Cancer Omaha / Urology Cancer Center

    Omaha, Nebraska, 68130-5606

    Luke Nordquist, MD

    Recruiting

  • University of California San Diego

    San Diego, California, 92093

    Rana McKay, MD

    Recruiting

  • Washington University in St. Louis

    St Louis, Missouri, 63130

    Terminated

Other trials in United States

About this study

Official title: A Phase 2, Open-label Study Evaluating Dosimetry, Randomized Dose Optimization, Dose Escalation and Efficacy of Ac-225 Rosopatamab Tetraxetan in Participants With PSMA PET-Positive Castration-Resistant Prostate Cancer

This is a four-part study evaluating the safety and efficacy of a PSMA-directed radioantibody (rosopatamab tetraxetan, conjugated to either In-111 or Ac-225). Part 1 will consist of one administration of In-111-rosopatamab tetraxetan to characterize the biodistribution of the radioantibody to target organs and prostate cancer lesions. Participants then will be enrolled into either Part 2 (Dose Optimization) or Part 3 (Dose Escalation and Expansion) depending on their prior treatment history. Part 4 will be an extended regimen in dose escalation and expansion. Participants qualifying for Part 2 will be randomized to receive Ac-225 rosopatamab tetraxetan in a single fractionated cycle (dose administration on Day 1 and Day 15) at either 45 or 60 kBq/Kg. Participants qualifying for Part 3 must have received prior Lu-177-PSMA-radioligand therapy and will receive Ac-225 rosopatamab tetraxetan in a single fractionated cycle at 45, 55, or 60 kBq/Kg. Dose limiting toxicities (DLTs) will be monitored in Part 3 to determine the recommended phase 2 dose (RP2D), and the study may enroll additional participants to be treated with the RP2D dose level. Participants qualifying for Part 4 will initially receive two doses (dose administration on Day 1 and Day 15) at the dose level selected in Part 2, followed by a single third dose of Ac-225 rosopatamab tetraxetan administered approximately 12 weeks after completion of the Part 2 fractionated dosing regimen. The starting dose level for Part 4 will be 22 kBq/kg (or fixed activity equivalent). Dose limiting toxicities (DLTs) will be monitored following administration of the third dose in Part 4 to determine the recommended phase 2 dose (RP2D) of a third dose of Ac-225 rosopatamab tetraxetan. Participants enrolled into any part will attend study visits which will include blood samples, electrocardiogram (ECG), radiographic imaging, and physical examinations along with other assessments.

Being tested
In-111 rosopatamab tetraxetan, 45 kBq/kg Ac-225 rosopatamab tetraxetan, 45 kBq/kg or equivalent fixed dose activity Ac-225 rosopatamab tetraxetan, 60 kBq/kg Ac-225 rosopatamab tetraxetan, Single dose 22 kBq/kg or equivalent fixed dose activity Ac-225 rosopatamab tetraxetan

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • In-111 rosopatamab tetraxetanBiological

    A single dose of 148 ± 37 MBq In-111 rosopatamab tetraxetan will be administered as an IV infusion over a period of 10 minutes.

  • 45 kBq/kg Ac-225 rosopatamab tetraxetanBiological

    45 kBq/kg Ac-225 rosopatamab tetraxetan will be administered as an IV infusion over a period of 10 minutes. Doses will be given two weeks apart for a total of two doses.

  • 45 kBq/kg or equivalent fixed dose activity Ac-225 rosopatamab tetraxetanBiological

    45 kBq/kg Ac-225 rosopatamab tetraxetan will be administered as an IV infusion over a period of 10 minutes. Doses will be given two weeks apart for a total of two doses.

  • 60 kBq/kg Ac-225 rosopatamab tetraxetanBiological

    60 kBq/kg Ac-225 rosopatamab tetraxetan will be administered as an IV infusion over a period of 10 minutes. Doses will be given two weeks apart for a total of two doses.

  • Single dose 22 kBq/kg or equivalent fixed dose activity Ac-225 rosopatamab tetraxetanBiological

    22 kBq/kg Ac-225 rosopatamab tetraxetan will be administered as an IV infusion over a period of 10 minutes. A single dose will be given.

  • Single dose 34 kBq/kg or equivalent fixed dose activity Ac-225 rosopatamab tetraxetanBiological

    34 kBq/kg Ac-225 rosopatamab tetraxetan will be administered as an IV infusion over a period of 10 minutes. A single dose will be given.

  • Single dose 45 kBq/kg or equivalent fixed dose activity Ac-225 rosopatamab tetraxetanBiological

    45 kBq/kg Ac-225 rosopatamab tetraxetan will be administered as an IV infusion over a period of 10 minutes. A single dose will be given.

  • 55 kBq/kg or equivalent fixed dose activity Ac-225 rosopatamab tetraxetanBiological

    55 kBq/kg Ac-225 rosopatamab tetraxetan will be administered as an IV infusion over a period of 10 minutes. Doses will be given two weeks apart for a total of two doses.

  • 60 kBq/kg or equivalent fixed dose activity Ac-225 rosopatamab tetraxetanBiological

    60 kBq/kg Ac-225 rosopatamab tetraxetan will be administered as an IV infusion over a period of 10 minutes. Doses will be given two weeks apart for a total of two doses.

Study groups in NCT06549465
Study groupRoleWhat they receive
Part 1: 148 ± 37 MBq In-111 rosopatamab tetraxetanExperimentalNot described
Receives: Biological: In-111 rosopatamab tetraxetan
Part 2: 45 kBq/kg Ac-225 rosopatamab tetraxetanExperimentalNot described
Receives: Biological: 45 kBq/kg Ac-225 rosopatamab tetraxetan
Part 2: 60 kBq/kg Ac-225 rosopatamab tetraxetanExperimentalNot described
Receives: Biological: 60 kBq/kg Ac-225 rosopatamab tetraxetan
Part 3: Dose Escalation and ExpansionExperimentalParticipants 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, or equivalent fixed dose activity) depending on the dose limiting toxicities (DLTs) observed.
Receives: Biological: 45 kBq/kg or equivalent fixed dose activity Ac-225 rosopatamab tetraxetan; Biological: 55 kBq/kg or equivalent fixed dose activity Ac-225 rosopatamab tetraxetan; Biological: 60 kBq/kg or equivalent fixed dose activity Ac-225 rosopatamab tetraxetan
Part 4: Dose Escalation and ExpansionExperimentalParticipants will initially receive two doses of the Part 2 selected dose level, followed by a single third dose of Ac-225 rosopatamab tetraxetan approximately 12 weeks after the completion of the Part 2 fractionated dosing regimen. Participants will be assigned to receive one of the three dose levels (22 kBq/kg, 34 kBq/kg, or 45 kBq/kg, or equivalent fixed dose activity) depending on the dose limiting toxicities (DLTs) observed.
Receives: Biological: Single dose 22 kBq/kg or equivalent fixed dose activity Ac-225 rosopatamab tetraxetan; Biological: Single dose 34 kBq/kg or equivalent fixed dose activity Ac-225 rosopatamab tetraxetan; Biological: Single dose 45 kBq/kg or equivalent fixed dose activity Ac-225 rosopatamab tetraxetan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Visual evaluation on whole body planar scans (days 1 and 4) with comparison to reference scans for the presence of radiolabeled rosopatamab textraxetan in organs of interest (e.g., liver, circulation, spleen) to determine biodistribution

    Measured: Day 1 and Day 4

  2. Part 2: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) overall, by severity, and leading to discontinuation of study intervention

    Measured: Screening through Week 12

  3. Part 2: Proportion of participants who achieve a greater than or equal to 50% decline in prostate-specific antigen (PSA50)

    Measured: Through end of study (approximately 3 years) or until PSA progression as defined by PCWG3 criteria

  4. Part 3: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) overall, by severity, and leading to discontinuation of study intervention

    Measured: Screening through Week 12

  5. Part 3: Determine the recommended Phase 2 dose (RP2D) of Ac-225 rosopatamab tetraxetan

    Measured: Day 1 through 6 weeks

  6. Part 3 (Participants treated at RP2D): Proportion of participants who achieve a greater than or equal to 50% decline in prostate-specific antigen (PSA50)

    Measured: Through end of study (approximately 3 years) or until PSA progression as defined by PCWG3 criteria

  7. Part 4: Incidence of AEs and SAEs overall, by severity, by relationship to study drug, and leading to discontinuation of study intervention

    Measured: Screening through Week 12

  8. Part 4: Determine the recommended Phase 2 dose (RP2D) of Ac-225 rosopatamab tetraxetan

    Measured: Through end of study (approximately 3 years)

Secondary outcomes (9)

  1. Part 2: Determine the clearance of rosopatamab tetraxetan and Ac-225 rosopatamab tetraxetan via measurement of whole blood and serum levels at specified serial timepoints

    Measured: Through Week 8

  2. Part 2: Radioactivity levels of Ac-225 rosopatamab tetraxetan

    Measured: Through Day 21

  3. Part 2: Radiation dosimetry of Ac-225 rosopatamab tetraxetan: Absorbed radiation dose (expressed as Gy/MBq) in normal organs

    Measured: Day 1 through Day 15

  4. Part 2: Biochemical progression-free survival (bPFS) as assessed by the Prostate Cancer Working Group 3 (PCWG3)

    Measured: Through end of study (approximately 3 years) or until disease progression

  5. Part 3: Proportion of participants who achieve PSA50

    Measured: Through end of study (approximately 3 years)

  6. Part 3: Determine the clearance of rosopatamab tetraxetan and Ac-225 rosopatamab tetraxetan from the circulation via measurement in the serum at specified serial timepoints

    Measured: Through Week 8

  7. Part 3: Radioactivity levels of Ac-225 rosopatamab tetraxetan

    Measured: Through Week 8

  8. Part 4: Proportion of participants who achieve PSA50

    Measured: Through end of study (approximately 3 years)

  9. Part 4: Biochemical progression-free survival (bPFS) as assessed by the Prostate Cancer Working Group 3 (PCWG3)

    Measured: Through end of study (approximately 3 years) or until disease progression

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2024
  2. Study start6 Aug 2024
  3. Primary completionAug 2027 (estimated)
  4. Study completionOct 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
93 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06549465
Sponsor's protocol ID
CONVERGE-01
Status last verified
Sep 2026
First submitted
31 Jul 2024
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing In-111 rosopatamab tetraxetan, 45 kBq/kg Ac-225 rosopatamab tetraxetan and 45 kBq/kg or equivalent fixed dose activity Ac-225 rosopatamab tetraxetan in people with PSMA PET-Positive Castration-Resistant Prostate Cancer, run by Convergent Therapeutics at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Director (CONVERGE01, CONVERGE01@convergentrx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Visual evaluation on whole body planar scans (days 1 and 4) with comparison to reference scans for the presence of radiolabeled rosopatamab textraxetan in organs of interest (e.g., liver, circulation, spleen) to determine biodistribution (time frame: Day 1 and Day 4). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06549465.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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