Study of Alpha Radioligand Therapy AB001 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
Conditions
Prostate Cancer (CRPC), Metastatic Castrate Resistant Prostate Cancer (mCRPC)Drugs
AB001Summary
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
Locations
1 location Found with status Recruiting
Eligibility Criteria
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
Study Plan
AB001 treated u00b9u2077u2077Lu-PSMA nau00efve mCRPC patients
EXPERIMENTAL
Dose Escalation will be initiated in u00b9u2077u2077Lu-PSMA nau00efve 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 nau00efve participants will be opened for dose finding and schedule optimisation.
DRUG:
AB001Description:
Pb-212 PSMA targeted alpha radioligand therapy
AB001 treated 177Lu-PSMA experienced mCRPC patients
EXPERIMENTAL
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.
DRUG:
AB001Description:
Pb-212 PSMA targeted alpha radioligand therapy
Outcome Measures
Primary Outcome Measures
To determine the safety and tolerability profile of AB001 in participants with mCRPC
Dose Escalation: To determine recommended AB001 Dose (MBq) in both 177Lu-PSMA nau00efve and 177Lu-PSMA experienced participants for Dose Expansion
Dose Escalation: To determine recommended AB001 Schedule (frequency of dose in cycles/weeks) in both 177Lu-PSMA nau00efve and 177Lu-PSMA experienced participants for Dose Expansion
Dose Expansion: To assess the recommended Dose (MBq) determined in Dose Escalation in both 177Lu-PSMA nau00efve and 177Lu-PSMA experienced participants for further clinical development of AB001
Dose Expansion: To assess the recommended AB001 Schedule (frequency of dose in cycles/weeks) determined in Dose Escalation in both 177Lu-PSMA nau00efve and 177Lu-PSMA experienced participants for further clinical development of AB001
Timeline
Last Updated
December 3, 2025Start Date
October 9, 2025Today
December 20, 2025Completion Date ( Estimated )
November 3, 2028
Sponsors of this trial
Lead Sponsor
ARTBIO Inc.