In the 212 Pb-ADVC001 trial, PSA decreased in 80% of patients — News-Medical

In a phase 1 clinical trial of the alpha-emitting radiopharmaceutical 212 Pb-ADVC001, prostate-specific antigen (PSA) levels decreased by at least 50% in 80% of participants with progressive metastatic prostate cancer. The TheraPb study included 22 patients who had previously received an androgen receptor signaling pathway inhibitor and taxane chemotherapy, News-Medical reports.

Early-phase results

Participants received 212 Pb-ADVC001 at doses ranging from 60 to 200 MBq. Treatment was administered at intervals of six, four, two, or one week; in total, patients could receive up to six doses across seven groups with different dosages and schedules. Researchers assessed toxicity, adverse events, PSA dynamics, radiographic progression-free survival, and the overall response rate.

According to the trial data, no dose-limiting toxicity was recorded, and the maximum tolerated dose was not established. The most common treatment-related adverse events were dry mouth and nausea; no serious adverse events were reported. Median radiographic progression-free survival was 11.2 months, while the overall response rate was 100%.

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Preparation for the next phase

The study committee recommended doses of 160 and 200 MBq for phase two of TheraPb. The trial was the first human study of 212 Pb-ADVC001. The results were published in the accelerated Late-Breaking Fast Track section of The Journal of Nuclear Medicine.

The drug targets the prostate-specific membrane antigen PSMA. Alpha emitters differ from beta emitters such as 177 Lu in that they release high-energy particles that travel through tissue only a few cell widths. The study authors noted that the safety profile and the ability to vary doses and frequency of administration provide grounds for studying combinations of the drug with other anticancer agents.