Status:
RECRUITING
Study of Alpha Radioligand Therapy AB001 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
Lead Sponsor:
ARTBIO Inc.
Conditions:
Prostate Cancer (CRPC)
Metastatic Castrate Resistant Prostate Cancer (mCRPC)
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
This Phase 1 study will evaluate the safety, tolerability, and preliminary effectiveness of AB001, an alpha-emitting radioligand targeting prostate-specific membrane antigen (PSMA), in patients with a...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Male participants at least 18 years of age
- ECOG PS of 0 to 2
- Progressive mCRPC
- Previous treatment with at least one novel ARPI
- Prior orchiectomy and/or ongoing androgen-deprivation therapy
- Prior treatment with at least one taxane regimen or patient refusing or considered appropriate by treating physician to delay taxane therapy
- 177Lu-PSMA experienced Group only: Prior treatment with at least one dose of 177Lu-PSMA
- At least one PSMA-avid distant metastatic lesion
- Adequate bone marrow, renal, and hepatic function
- Exclusion Criteria
- Blockage in the bladder or kidneys
- Untreated or uncontrolled brain metastases. Treated brain metastases are permitted provided they are neurologically stable
- Symptomatic, or clinical or radiologic findings indicative of impending cord compression.
- History of myelodysplastic syndrome (MDS), treatment-related acute myeloid leukaemia or features suggestive of MDS/acute myeloid leukaemia.
- A known additional malignancy that has required active treatment within the past two years before start of study treatment, except for adequately treated basal or squamous cell carcinoma of the skin, or carcinoma in situ that has undergone curative therapy
Exclusion
Key Trial Info
Start Date :
November 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 3 2028
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07214961
Start Date
November 3 2025
End Date
November 3 2028
Last Update
December 22 2025
Active Locations (2)
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1
BAMF Health
Grand Rapids, Michigan, United States, 49503
2
United Theranostics
Princeton, New Jersey, United States, 08540