Prostatic Neoplasms Clinical Trial
Official title:
TheraPb: Phase I/IIa Dose Escalation and Toxicity Study of [212Pb]Pb-ADVC001 in Metastatic Prostate Adenocarcinoma
This is a first-in-human, dose escalation and efficacy study of [212Pb]Pb-ADVC001 in participants with PSMA-positive metastatic Castration Resistant Prostate Cancer (mCRPC).
This is a single arm, non-randomized, toxicity and dose finding study. The trial will include a maximum of 18 patients with confirmed mCRPC and no prior history of radioligand therapy. The study is based on a 3 + 3 design with 4 cohorts of patients receiving escalating doses 60, 90, 120 and 150MBq of [212Pb]Pb-ADVC001. Each patient in each cohort will be given the same dose and a maximum of 4 cycles of therapy administered at 6 weekly intervals. The decision to recruit the next cohort of patients and escalate the dose will be made after reviewing all safety data from the previous cohort acquired over 6 weeks after the first cycle of therapy. In this manner, recruitment of the next cohort can occur before all treatment cycles have been administered to the previous cohort. ;
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