NCT07214961Active, not recruitingPhase 1
Study of Alpha Radioligand Therapy AB001 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biodistribution and Antitumour Activity of the Alpha Radioligand Therapy AB001 in Patients With Metastatic Castration Resistant Prostate Cancer
Source: ClinicalTrials.gov · Last updated 7 Apr 2026
Brief summary (registry, in English)
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 advanced prostate cancer who are either 177Lu-PSMA naïve or experienced. The study includes dose escalation to identify a recommended dose and dose expansion to further assess safety and anti-tumour activity. Primary objectives are to characterize the safety profile and determine the optimal dose and schedule for future studies
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 21 Jul 2025
- Start date
- 3 Nov 2025
- Primary completion date
- 3 Nov 2027
- Lead sponsor
- ARTBIO Inc.
- Diseases
- Prostate cancer
- NCT number
- NCT07214961
- EudraCT number
- 2024-516523-14
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 80
- From 3 Nov 2025 to the primary completion date, 3 Nov 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- 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.
Who the study is looking for
- 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 prior 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| BAMF Health Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| XCancer Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| United Theranostics Coordinator of this site? Confirm its status | Princeton | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.