Evaluating a new treatment for advanced prostate cancer
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 study is testing a new radioantibody treatment for advanced prostate cancer to see how safe it is and what the best dose might be for patients with a specific type of the disease.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Convergent Therapeutics Industry-sponsored |
| Drugs / interventions | denosumab, CAR-T, chemotherapy, rosopatamab |
| Locations | 9 sites (San Diego, California and 8 other locations) |
| Trial ID | NCT06549465 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a three-part evaluation of the safety and efficacy of a PSMA-directed radioantibody, rospatamab tetraxetan, in patients with PSMA PET-positive castration-resistant prostate cancer (CRPC). The first part involves administering In-111-rosopatamab tetraxetan to assess its biodistribution in the body. Depending on their treatment history, participants will then be randomized into either a dose optimization phase or a dose escalation phase, where they will receive varying doses of Ac-225 rosopatamab tetraxetan. The study aims to monitor dose-limiting toxicities to establish the recommended phase 2 dose for further evaluation.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with progressive, metastatic castration-resistant prostate cancer who have specific criteria for disease progression.
Not a fit: Patients who do not have PSMA PET-positive disease or those who have not previously received Lu-177-PSMA-radioligand therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced prostate cancer that is resistant to standard therapies.
How similar studies have performed: While this approach is novel in its specific application, similar studies using PSMA-targeted therapies have shown promising results in treating prostate cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Progressive CRPC defined as castrate levels of testosterone and progressing by at least one of the following criteria: 1. Serum PSA progression consisting of two consecutive increases in PSA measured at least 1 week apart. The minimal study baseline value is 2.0 ng/mL 2. 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) 3. Progression of bone disease defined by PCWG3 as evaluable disease or new bone lesions by bone scan 4. Identification of new soft tissue or bone lesions on PSMA PET imaging * Metastatic disease defined as either or both of the following: 1. Parts 1, 2 and 3: Documented M1 disease on conventional imaging (CT/MRI of the chest/abdomen/pelvis and/or Technetium 99m \[99mTc\] whole-body bone scan) 2. Parts 1 and 2 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 study drug administration * 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 Exclusion Criteria: * 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 Part 2 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 Part 3 Only: * Prior PSMA-targeted therapy (e.g., antibody-drug conjugates or CAR-T therapy), except for Lu-177-PSMA-radioligand therapy
Where this trial is running
San Diego, California and 8 other locations
- University of California San Diego — San Diego, California, United States (Recruiting)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- Washington University in St. Louis — St Louis, Missouri, United States (Recruiting)
- X Cancer Omaha / Urology Cancer Center — Omaha, Nebraska, United States (Recruiting)
- Laura & Isaac Perlmutter Cancer Center — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- New York Presbyterian/Weill Cornell Medical Center — New York, New York, United States (Recruiting)
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
- The Cleveland Clinic Foundation — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Study Director
- Email: CONVERGE01@convergentrx.com
- Phone: CONVERGE01
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.