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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

March 15, 2023

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2029

Conditions
Prostate CancerMetastatic Castration-resistant Prostate Cancer
Interventions
DRUG

[²¹²Pb]Pb-ADVC001

"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~Ph2a Expansion~Drug: \[²¹²Pb\]Pb-ADVC001 at recommended phase 2 dose and schedule"

Trial Locations (2)

4029

RECRUITING

Royal Brisbane & Women's Hospital, Brisbane

4102

RECRUITING

Princess Alexandra Hospital, Brisbane

All Listed Sponsors
lead

AdvanCell Pty Limited

INDUSTRY