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RecruitingPhase 1Phase 2NCT05720130

Phase Ib/IIa Dose Escalation and Expansion Study of [²¹²Pb]Pb-ADVC001 in Metastatic Prostate Cancer (TheraPb - Phase I/II Study).

Sponsor

AdvanCell Pty Limited

Enrollment

100 participants

Start Date

Mar 15, 2023

Study Type

INTERVENTIONAL

Conditions

Prostate CancerMetastatic Castration-resistant Prostate CancerMetastatic Hormone Sensitive Prostate Cancer

Summary

This is a prospective, open-label, dose-escalation and randomized dose optimization and expansion study. The Phase Ib portion of the study aims to determine the safety and tolerability of escalating doses of \[212Pb\]Pb-ADVC001 administered every 6, 4, 2 or 1 week(s) and establish the recommended phase 2 doses (RP2D). The Phase 2a expansion aims to assess the efficacy and safety of \[212Pb\]Pb-ADVC001 at the RP2 doses in 3 participant groups.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a targeted radiation drug called [212Pb]Pb-ADVC001 — a radioactive molecule designed to seek out prostate cancer cells and destroy them from within — in men with metastatic prostate cancer that has progressed despite other treatments. This is an early-phase trial focused on finding the right dose and checking safety. **You may be eligible if...** - You are a man with confirmed metastatic prostate cancer (spread beyond the prostate) - Your cancer has gotten worse despite treatments, with rising PSA or new lesions on imaging - Your tumor tests positive for a surface marker called PSMA on a PET scan - Depending on the study group: you may need prior exposure to hormone therapy and/or chemotherapy, or you may be newly progressing on hormone therapy with high PSA **You may NOT be eligible if...** - Your blood counts, kidney, or liver function are significantly abnormal - You have certain serious active infections or autoimmune conditions - You have had major surgery or other cancer treatments very recently - You are unable to comply with safety monitoring (including radiation safety measures) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG[²¹²Pb]Pb-ADVC001 (Phase 1b)

Ph1b Escalation Drug: \[²¹²Pb\]Pb-ADVC001administered intravenously per dose escalation scheme Dose Level 1 \- 60 MBq, 4 cycles every 6 weeks Dose Level 2a \- 120 MBq, 4 to 6 cycles every 4 weeks Dose Level 2b \- Optional cohort of 120 MBq, 4 to 6 cycles every 2 weeks Dose Level 3a \- 160 MBq, 4 to 6 cycles every 4 weeks Dose Level 3b \- Optional cohort of 160 MBq, 4 to 6 cycles every 2 weeks Dose Level 3c \- Optional cohort of 160 MBq, 4 to 6 cycles every week Dose Level 4a * 200 MBq, 4 to 6 cycles every 4 weeks Dose Level 4b \- Optional cohort of 200 MBq, 4 to 6 cycles every 2 weeks Dose Level 4c \- Optional cohort of 200MBq, 4 to 6 cycles every week

DRUG[²¹²Pb]Pb-ADVC001 (Phase 2a)

Ph2a Expansion Drug: All participants are randomized 1:1 to receive either 160 or 200 MBq of ADVC001. Each participant receives up to 12 doses according to an adaptive dosing schedule and rules allowing for a treatment pause ('treatment holiday') with the possibility of subsequent therapy restarts. All participants continue ADT throughout the study. Group 1 participants receive ongoing ARPi as per standard of care, and Group 2 participants also are randomized to receive ADVC001 ± concomitant ARPi.

Locations(3)

Royal Brisbane & Women's Hospital

Brisbane, Queensland, Australia

Princess Alexandra Hospital

Brisbane, Queensland, Australia

Gold Coast University Hospital

Southport, Queensland, Australia

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NCT05720130

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