Study of Alpha Radioligand Therapy AB001 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
Purpose
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
Conditions
- Prostate Cancer (CRPC)
- Metastatic Castrate Resistant Prostate Cancer (mCRPC)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Male
- Accepts Healthy Volunteers
- No
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 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
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 Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- This is an open-label, noncontrolled, multinational, multicentre, interventional Phase 1 clinical study of AB001 in patients with advanced mCRPC. 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.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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. |
|
|
Experimental 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. |
|
Recruiting Locations
BAMF Health
Grand Rapids 4994358, Michigan 5001836 49503
Grand Rapids 4994358, Michigan 5001836 49503
United Theranostics
Princeton 5102922, New Jersey 5101760 08540
Princeton 5102922, New Jersey 5101760 08540
More Details
- Status
- Recruiting
- Sponsor
- ARTBIO Inc.