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NCT06549465 | RECRUITING | PSMA PET-Positive Castration-Resistant Prostate Cancer

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)
Sponsor:

Convergent Therapeutics

Brief Summary:

This is a three-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. 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 enrolled into any part will attend study visits which will include blood samples, electrocardiogram (ECG), radiographic imaging, and physical examinations along with other assessments.

Condition or disease

PSMA PET-Positive Castration-Resistant Prostate Cancer

Intervention/treatment

In-111 rosopatamab tetraxetan

45 kBq/kg Ac-225 rosopatamab tetraxetan

55 kBq/kg Ac-225 rosopatamab tetraxetan

60 kBq/kg Ac-225 rosopatamab tetraxetan

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 60 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2024-08-06
Estimated Primary Completion Date : 2025-12
Estimated Study Completion Date : 2027-04

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers:
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 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) 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 and at low risk for HIV-related illness
      • Part 3 Only
        • * Prior treatment with Lu-177-PSMA-radioligand therapy
        • * Prior treatment with only one taxane-based chemotherapy is required
        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
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)

Location Details

NCT06549465

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

University of California San Diego

San Diego, California, United States, 92093

RECRUITING

United States, Massachusetts

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

RECRUITING

United States, Missouri

Washington University in St. Louis

Saint Louis, Missouri, United States, 63130

RECRUITING

United States, Nebraska

X Cancer Omaha / Urology Cancer Center

Omaha, Nebraska, United States, 68130-5606

RECRUITING

United States, New York

Laura & Isaac Perlmutter Cancer Center

New York, New York, United States, 10016

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

RECRUITING

United States, Ohio

The Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195