AdvanCell has dosed the first subject in its Phase I/II TheraPb clinical trial of ²¹²Pb-ADVC001 to treat PSMA-positive metastatic castration-resistant prostate cancer (mCRPC).
The open-label, multicentre trial will analyse the tolerability and safety and detect a recommended Phase II dose of the drug candidate as primary objectives.
Dosimetry measures, radiographic progression-free survival (rPFS), and prostatic-specific antigen (PSA) response will comprise the secondary objectives of the trial.
The company launched various study centres for the trial, which are now open for subject enrolment.
A targeted alpha therapy, ²¹²Pb-ADVC001 attaches to PSMA expressed in prostate cancer.
AdvanCell CEO Andrew Adamovich said: “The first patient dosed with an AdvanCell therapeutic candidate represents a major milestone for the company, our scientists, clinical trial sites, and our patients.
“We believe that ²¹²Pb is the ideal radioisotope to realise the full therapeutic power of targeted alpha therapy.
“This promise is strongly supported by preclinical results for ²¹²Pb-ADVC001, which demonstrate the potential for best-in-class safety and efficacy.”
Since 2020, the company developed the drug and entered a partnership with a radiopharmaceutical company on a supply chain for ²¹²Pb radioisotope and radioligand as well as a network for drug production.
AdvanCell also secured funding worth $13m from investors including Morningside and acquired a 35,000ft² manufacturing site.
