Brief Summary
The aim of this study is to determine the maximum safe and effective dose of a novel therapeutic ADVC001 complexed with the radio-isotope alpha-212 ([212Pb]Pb-ADVC001) for the treatment of metastatic prostate cancer.
Intervention/Treatment
- Drug: [212Pb]Pb-ADVC001
Inclusion Criteria
- Male aged 18 years or older with metastatic adenocarcinomacancer arising from mucus-producing glands in organs of the prostate, defined by documented histopathology of prostate adenocarcinoma or metastatic disease typical of prostate cancer (i.e. Involving bone or pelvic lymph nodessmall bean-shaped structures that filters harmful substances from lymph fluid or para-aortic lymph nodes).
- Patients with castration-resistant prostate cancer that have received at least one cycle of androgen receptor therapy and exposure to a taxane-based chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells unless considered contraindicated by a medical oncologist or patient declines treatment.
- Progressive disease with rising PSA level, or new lesion(s) in the viscera or lymph nodes as per RECIST 1.1 or in bone as per Prostate Cancer Working Group 3.
- Significant PSMA avidity on [68Ga]Ga-PSMA PET/CT.
- ECOG Performance status 0 to 2.
- Adequate renal, bone and liver function (Absolute neutrophil count: greater than or equal to 2 x 109 /L , Hemoglobin: greater than or equal to 90 g/L, Platelet count: greater than or equal to 150,000 x 109/L, Serum creatinine: less than 1.5 x upper limit of normal (ULN) i.e = 125 umol/L or calculated creatinine clearance greater than or equal to 60 mL/min/1.73 m2 by Cockcroft-Gault formula, Serum total bilirubin: less than 1.5 x ULN (unless the patient has Gilbert’s syndrome in which case direct bilirubin must be normal), Serum AST and ALT: less than 1.5 x ULN in the absence of liver metastases; less than 3 x ULN if due to liver metastases (in both circumstances bilirubin must meet entry criteria).
- Estimated life expectancy greater than 12 weeks.
- Willing and able to comply with all study requirements, including the timing and nature of all required assessments (i.e. blood testing and scanning.).
- Have provided written Informed Consent for participation in this trial.