Study of Alpha Radioligand Therapy AB001 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
NCT ID: NCT07214961
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
80 participants
INTERVENTIONAL
2025-11-03
2028-11-03
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
The study includes the following main parts:
Dose Escalation: To assess the safety and tolerability of AB001 and determine the recommended dose level and treatment schedule in both 177Lu-PSMA naïve and 177Lu-PSMA experienced groups to take into the Expansion part.
Dose Expansion: To further characterise the antitumour activity and safety profile of the recommended dose and schedule in both 177Lu-PSMA naïve and 177Lu-PSMA experienced groups for further development of AB001 in specific patient populations.
Dose Escalation will seamlessly progress into Dose Expansion.
The study will include several sub-studies to enable characterisation of the biodistribution, body clearance, and PK of AB001 in participants with mCRPC.
TREATMENT
NONE
Study Groups
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AB001 treated ¹⁷⁷Lu-PSMA naïve mCRPC patients
Dose Escalation will be initiated in ¹⁷⁷Lu-PSMA naïve mCRPC patients with the first cohort of participants receiving a starting dose of 100 MBq Pb212 (AB001) administered by slow injection on Day 1 of a 6-week (42-day) cycle. Four cycles of study treatment are planned; however, individual participants may continue up to a maximum of six treatment cycles provided they meet defined criteria. Subsequent cohorts of 177Lu-PSMA naïve participants will be opened for dose finding and schedule optimisation.
AB001
Pb-212 PSMA targeted alpha radioligand therapy
AB001 treated 177Lu-PSMA experienced mCRPC patients
For the 177Lu-PSMA experienced Group, the first cohort will initiate enrolment with a starting dose of 100 MBq Pb212 (AB001) administered by slow injection on Day 1 of a 6-week (42-day) cycle. Four cycles of study treatment are planned; however, individual participants may continue up to a maximum of six treatment cycles provided they meet defined criteria. Subsequent cohorts of 177Lu-PSMA experienced participants will be opened for dose finding and schedule optimisation.
AB001
Pb-212 PSMA targeted alpha radioligand therapy
Interventions
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AB001
Pb-212 PSMA targeted alpha radioligand therapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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ARTBIO Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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CMO
Role: STUDY_CHAIR
ARTBIO Inc.
Locations
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BAMF Health
Grand Rapids, Michigan, United States
United Theranostics
Princeton, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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Mark Olson
Role: primary
United Theranostics
Role: primary
Other Identifiers
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2024-516523-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AB001-101
Identifier Type: -
Identifier Source: org_study_id