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

RECRUITINGPHASE1/PHASE2

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

NCT05720130•AdvanCell Pty Limited

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Documented metastatic adenocarcinoma of the prostate, confirmed by histopathology.
•Progressive metastatic prostate cancer demonstrated by at least one of the following:
•1. Increase in PSA greater than 25% and \> 2 ng/mL above nadir, confirmed by progression at two timepoints at least three weeks apart
•2. Progressive disease or new lesion(s) (relative to previous imaging) in the viscera or lymph nodes as per the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or in bone as per Prostate Cancer Clinical Trials Working Group 3 (PCWG3).
•For Phase 1b Dose Escalation: Metastatic castration-resistant prostate cancer (mCRPC) with exposure to at least one ARPi and taxane-based chemotherapy at any time in the course of their disease (unless taxanes considered contraindicated or declined by participant as documented in the patient's source documents and eCRF).
•For Phase 2a Dose Expansion:
•1. Group 1: Metastatic hormone-sensitive prostate cancer (mHSPC) with a sub-optimal PSA response defined as PSA ≥ 0.2 ng/mL despite receiving androgen deprivation therapy (ADT) and an androgen receptor pathway inhibitor (ARPi) without evidence of disease progression
•2. Group 2: Progressive mCRPC post ≥ 1 ARPi; 177Lutetium (177Lu)-PSMA-naïve and not previously treated with chemotherapy for CRPC
•3. Group 3: Progressive mCRPC with prior exposure to 177Lu-PSMA and ARPi
•Has disease that is prostate specific membrane antigen (PSMA) positive, as demonstrated by ⁶⁸Ga-PSMA-PET/CT or ¹⁸F-based PSMA PET/CT and confirmed as eligible by local reader. PSMA-positive participants are defined as those having at least one tumor lesion with ⁶⁸Ga- or ¹⁸F- PSMA PET CT uptake greater than normal liver (based on visual assessment) and all tumor lesions larger than size criteria with ⁶⁸Ga- or ¹⁸F-PSMA uptake greater than liver \[short axis size criteria: organs ≥ 1 cm, lymph nodes ≥ 2.5 cm, bones (soft tissue component) ≥ 1 cm\].
+2 more criteria

Exclusion Criteria

•Has received prior systemic radioligand therapy with the exception of prior radium-223. Prior 177Lu-PSMA is required for Phase 2a Group 3 participants.
•Systemic anti-cancer therapy and/or radiation therapy within four weeks of C1D1 or has received any investigational agent within four weeks of C1D1.
•Has malignancies other than prostate cancer within 3 years prior to enrolment, except for those with a negligible risk of metastases
•Known CNS metastases or symptoms of spinal cord compression or impending spinal cord compression. Patients with prior treatment for spinal cord compression should be clinically stable off steroids for at least 4 weeks.
•Has diffuse bone-marrow involvement, i.e, "superscan", defined as bone scintigraphy in which there is excessive skeletal radioisotope uptake.
•Has a serious active or sub-clinical infection, or angina pectoris, or heart failure (New York Heart Association \[NYHA\] Class III or IV), or significantly prolonged QT interval, or other serious illness which might impair the ability to participate in this study to the full extent, or which may require treatment that could interact with study treatment.
•Has a known alteration in breast cancer genes (BRCA) BRCA1 or BRCA2 and are eligible to receive poly ADP ribose polymerase (PARP) inhibitor therapy according to their treating institution's standard of care.

Locations (3)

Royal Brisbane & Women's Hospital

Brisbane, Queensland, Australia

Princess Alexandra Hospital

Brisbane, Queensland, Australia

Gold Coast University Hospital

Southport, Queensland, Australia

Key Dates

Start Date

March 15, 2023

Primary Completion Date

January 31, 2029

Completion Date

June 1, 2029

Last Updated

February 20, 2026

Enrollment

100

ESTIMATED participants

Conditions

Prostate CancerMetastatic Castration-resistant Prostate CancerMetastatic Hormone Sensitive Prostate Cancer

Interventions

[²¹²Pb]Pb-ADVC001 (Phase 1b)

DRUG

[²¹²Pb]Pb-ADVC001 (Phase 2a)

DRUG

Contacts

Anna Karmann

CONTACT

612 8000 4199 contact@advancell.com.au

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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