Prostate CancerPhase 1/2NCT05720130
Phase Ib/IIa Dose Escalation and Expansion Study of [²¹²Pb]Pb-ADVC001 in Metastatic Prostate Cancer (TheraPb - Phase I/II Study).
A Phase 1/2 study testing [²¹²Pb]Pb-ADVC001 (Phase 1b) and [²¹²Pb]Pb-ADVC001 (Phase 2a) in people with Prostate Cancer and Metastatic Castration-resistant Prostate Cancer, run by AdvanCell Pty Limited at 3 sites in Australia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Metastatic Hormone Sensitive Prostate Cancer
- What is being tested?
- [²¹²Pb]Pb-ADVC001 (Phase 1b) and [²¹²Pb]Pb-ADVC001 (Phase 2a)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesAustralia
- Study dates
- 15 Mar 2023to 1 Jun 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented metastatic adenocarcinoma of the prostate, confirmed by histopathology.
- Progressive metastatic prostate cancer demonstrated by at least one of the following:
- Increase in PSA greater than 25% and > 2 ng/mL above nadir, confirmed by progression at two timepoints at least three weeks apart
- 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:
Show all 12Show fewer
- 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
- Group 2: Progressive mCRPC post ≥ 1 ARPi; 177Lutetium (177Lu)-PSMA-naïve and not previously treated with chemotherapy for CRPC
- 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].
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
- Adequate haematological, renal, and liver function.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia3 sites, 3 recruiting
- Recruiting
Royal Brisbane & Women's Hospital
Brisbane, Queensland, 4029
David Wyld
- Recruiting
Princess Alexandra Hospital
Brisbane, Queensland, 4102
Aaron Hansen
- Recruiting
Gold Coast University Hospital
Southport, Queensland, 4215
Robert Mason
About this study
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.
- Conditions
- Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Metastatic Hormone Sensitive Prostate Cancer
- Being tested
- [²¹²Pb]Pb-ADVC001 (Phase 1b), [²¹²Pb]Pb-ADVC001 (Phase 2a)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[²¹²Pb]Pb-ADVC001 (Phase 1b)Drug
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
[²¹²Pb]Pb-ADVC001 (Phase 2a)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1b | Experimental | Phase 1b Dose Escalation: Participants with PSMA-positive mCRPC who have had exposure to at least one ARPi and taxane-based chemotherapy (unless taxanes contraindicated or declined) at any time in the course of their disease. Receives: Drug: [²¹²Pb]Pb-ADVC001 (Phase 1b) |
| Phase 2a | Experimental | Group 1: Participants with PSMA-positive mHSPC with PSA ≥ 0.2 ng/mL despite androgen deprivation therapy (ADT) and an androgen receptor pathway inhibitor (ARPi) without evidence of disease progression
Group 2: Participants with PSMA-positive mCRPC who have had exposure to at least one ARPi at any time in the course of their disease and has not received a taxane for the treatment of mCRPC.
Group 3: Participants with PSMA-positive mCRPC who have had exposure to at least one ARPi and to 177Lu-PSMA at any time in the course of their disease. Receives: Drug: [²¹²Pb]Pb-ADVC001 (Phase 2a) |
What is being measured
The primary outcome is the main question the study is designed to answer.
RP2D (Phase 1b)
Incidence and severity of dose-limiting toxicities, as defined in Section 6.5 of the protocol and assessed in accordance with NCI CTCAE Version 5.0.
Incidence and severity of adverse events, SAEs and radiation adverse events of special interest, assessed in accordance with NCI CTCAE Version 5.0.
Measured: Up to 60 Months
Therapeutic efficacy as assessed by PSA response (Phase 1b/2a)
PSA response defined as a reduction from baseline PSA level of at least 50% (PSA 50) and 90% (PSA 90), confirmed by a follow-up PSA.
Measured: Up to 60 months
Therapeutic efficacy as assessed by objective response rate and disease control rate (Phase 1b/2a)
Objective response rate (OCR) and disease control rate (DCR) derived from CT imaging based on RECIST 1.1 and Prostate Cancer Trials Working Group 3.
Measured: Up to 60 months
Therapeutic efficacy as assessed by radiographic progression-free survival (Phase 1b/2a)
Radiographic progression-free survival (rPFS) defined as the time from date of first dosing to the occurrence of one of the following: 1. Progression of measurable lesions using RECIST 1.1. 2. Progression of bone lesions using Prostate Cancer Working Group 3 criteria. 3. Death due to any cause.
Measured: Up to 60 months
Therapeutic efficacy as assessed by progression-free survival (Phase 1b/2a)
Progression-free survival defined as the time from date of first dosing to the occurrence of one of the following: 1. Radiographic progression per RECIST 1.1 or bone scan in accordance with PCWG3 criteria. 2. Clinical progression as determined by investigator assessment. 3. PSA progression defined by PCWG3. 4. Death due to any cause.
Measured: Up to 60 months
Therapeutic efficacy as assessed by overall survival (Phase 1b/2a)
Overall survival defined as the time from date of first dosing to death from any cause.
Measured: Up to 60 months
Secondary outcomes (4)
Maximum tolerated dose (MTD) (Phase 1b)
Incidence and severity of dose-limiting toxicities, as defined in Section 6.5 of the protocol and assessed in accordance with NCI CTCAE Version 5.0.
Measured: Up to 60 months
Safety and Tolerability (Phase 1b/2a)
Incidence and severity of adverse events, SAEs and radiation adverse events of special interest, assessed in accordance with NCI CTCAE Version 5.0.
Measured: Up to 60 months
Dosimetry (Phase 1b/2a)
Absorbed radiation doses (expressed as Gy/MBq) of administered [²¹²Pb]Pb-ADVC001 to organs at risk and tumor lesions.
Measured: Day 1 of the first cycle through to the end of treatment (28 days after administration of the last treatment cycle).
Time to next non-study anti-cancer treatment from completion of [²¹²Pb]Pb-ADVC001 treatment (Phase 2a)
Median time to commencement of next (non-study) anti-cancer treatment following completion of [²¹²Pb]Pb-ADVC001 treatment
Measured: Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start15 Mar 2023
- Primary completion31 Jan 2029 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AdvanCell Pty Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aaron Hansen, Principal investigator, Princess Alexandra Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05720130
- Sponsor's protocol ID
- PSMA-AC-01
- Status last verified
- Feb 2026
- First submitted
- 7 Jan 2023
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib/IIa Dose Escalation and Expansion Study of [²¹²Pb]Pb-ADVC001 in Metastatic Prostate Cancer (TheraPb - Phase I/II Study).
- ClinicalTrials.gov ID
- NCT05720130
- Acronym / sponsor ID
- PSMA-AC-01
- Conditions
- Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Metastatic Hormone Sensitive Prostate Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- AdvanCell Pty LimitedIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 9 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1b | Experimental | Drug: [²¹²Pb]Pb-ADVC001 (Phase 1b)Phase 1b Dose Escalation: Participants with PSMA-positive mCRPC who have had exposure to at least one ARPi and taxane-based chemotherapy (unless taxanes contraindicated or declined) at any time in the course of their disease. |
| Phase 2a | Experimental | Drug: [²¹²Pb]Pb-ADVC001 (Phase 2a)Group 1: Participants with PSMA-positive mHSPC with PSA ≥ 0.2 ng/mL despite androgen deprivation therapy (ADT) and an androgen receptor pathway inhibitor (ARPi) without evidence of disease progression Group 2: Participants with PSMA-positive mCRPC who have had exposure to at least one ARPi at any time in the course of their disease and has not received a taxane for the treatment of mCRPC. Group 3: Participants with PSMA-positive mCRPC who have had exposure to at least one ARPi and to 177Lu-PSMA at any time in the course of their disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Documented metastatic adenocarcinoma of the prostate, confirmed by histopathology.
- Progressive metastatic prostate cancer demonstrated by at least one of the following:
- 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:
- 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].
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [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 | Phase 1b |
| [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. | Drug | Phase 2a |
Primary outcome
RP2D (Phase 1b)
Time frame: Up to 60 Months
Incidence and severity of dose-limiting toxicities, as defined in Section 6.5 of the protocol and assessed in accordance with NCI CTCAE Version 5.0. Incidence and severity of adverse events, SAEs and radiation adverse events of special interest, assessed in accordance with NCI CTCAE Version 5.0.
Therapeutic efficacy as assessed by PSA response (Phase 1b/2a)
Time frame: Up to 60 months
PSA response defined as a reduction from baseline PSA level of at least 50% (PSA 50) and 90% (PSA 90), confirmed by a follow-up PSA.
Therapeutic efficacy as assessed by objective response rate and disease control rate (Phase 1b/2a)
Time frame: Up to 60 months
Objective response rate (OCR) and disease control rate (DCR) derived from CT imaging based on RECIST 1.1 and Prostate Cancer Trials Working Group 3.
Therapeutic efficacy as assessed by radiographic progression-free survival (Phase 1b/2a)
Time frame: Up to 60 months
Radiographic progression-free survival (rPFS) defined as the time from date of first dosing to the occurrence of one of the following: 1. Progression of measurable lesions using RECIST 1.1. 2. Progression of bone lesions using Prostate Cancer Working Group 3 criteria. 3. Death due to any cause.
Therapeutic efficacy as assessed by progression-free survival (Phase 1b/2a)
Time frame: Up to 60 months
Progression-free survival defined as the time from date of first dosing to the occurrence of one of the following: 1. Radiographic progression per RECIST 1.1 or bone scan in accordance with PCWG3 criteria. 2. Clinical progression as determined by investigator assessment. 3. PSA progression defined by PCWG3. 4. Death due to any cause.
Therapeutic efficacy as assessed by overall survival (Phase 1b/2a)
Time frame: Up to 60 months
Overall survival defined as the time from date of first dosing to death from any cause.
4 secondary outcomes
Maximum tolerated dose (MTD) (Phase 1b)
Time frame: Up to 60 months
Safety and Tolerability (Phase 1b/2a)
Time frame: Up to 60 months
Dosimetry (Phase 1b/2a)
Time frame: Day 1 of the first cycle through to the end of treatment (28 days after administration of the last treatment cycle).
Time to next non-study anti-cancer treatment from completion of [²¹²Pb]Pb-ADVC001 treatment (Phase 2a)
Time frame: Up to 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aaron Hansen principal investigator
Princess Alexandra Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing [²¹²Pb]Pb-ADVC001 (Phase 1b) and [²¹²Pb]Pb-ADVC001 (Phase 2a) in people with Prostate Cancer and Metastatic Castration-resistant Prostate Cancer, run by AdvanCell Pty Limited at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Karmann (612 8000 4199, contact@advancell.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RP2D (Phase 1b) (time frame: Up to 60 Months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.