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Prostate Cancer (CRPC)Phase 1ARTISANNCT07214961

Study of Alpha Radioligand Therapy AB001 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

A Phase 1 study testing AB001 in people with Prostate Cancer (CRPC) and Metastatic Castrate Resistant Prostate Cancer (mCRPC), run by ARTBIO Inc. at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This Phase 1 study will evaluate the safety, tolerability, and preliminary effectiveness of AB001, an alpha-emitting radioligand targeting prostate-specific membrane antigen (PSMA), in patients with advanced prostate cancer who are either 177Lu-PSMA naïve or experienced. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
AB001
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
3 sitesUnited States
Study dates
3 Nov 2025to 3 Nov 2028
Phase
Phase 1
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

  • Male participants at least 18 years of age
  • ECOG PS of 0 to 2
  • Progressive mCRPC
  • Previous treatment with at least one novel ARPI
  • Prior orchiectomy and/or prior or ongoing androgen-deprivation therapy
  • Prior treatment with at least one taxane regimen or patient refusing or considered appropriate by treating physician to delay taxane therapy
Show all 9Show fewer
  • 177Lu-PSMA experienced Group only: Prior treatment with at least one dose of 177Lu-PSMA
  • At least one PSMA-avid distant metastatic lesion
  • Adequate bone marrow, renal, and hepatic function

Who cannot join

  • Blockage in the bladder or kidneys
  • Untreated or uncontrolled brain metastases. Treated brain metastases are permitted provided they are neurologically stable
  • Symptomatic, or clinical or radiologic findings indicative of impending cord compression.
  • History of myelodysplastic syndrome (MDS), treatment-related acute myeloid leukaemia or features suggestive of MDS/acute myeloid leukaemia.
  • A known additional malignancy that has required active treatment within the past two years before start of study treatment, except for adequately treated basal or squamous cell carcinoma of the skin, or carcinoma in situ that has undergone curative therapy

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • BAMF Health

    Grand Rapids, Michigan, 49503

  • XCancer

    Omaha, Nebraska, 68130

  • United Theranostics

    Princeton, New Jersey, 08540

Other trials in United States

About this study

Official title: Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biodistribution and Antitumour Activity of the Alpha Radioligand Therapy AB001 in Patients With Metastatic Castration Resistant Prostate Cancer

This Phase 1 study will evaluate the safety, tolerability, and preliminary effectiveness of AB001, an alpha-emitting radioligand targeting prostate-specific membrane antigen (PSMA), in patients with advanced prostate cancer who are either 177Lu-PSMA naïve or experienced. The study includes dose escalation to identify a recommended dose and dose expansion to further assess safety and anti-tumour activity. Primary objectives are to characterize the safety profile and determine the optimal dose and schedule for future studies

Being tested
AB001
Keywords
radioligand therapy, Pb-212, castrate-resistant prostate cancer, alpha particles, metastatic, mCRPC, Lu-177
Medical subject headings
Prostatic Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AB001Drug

    Pb-212 PSMA targeted alpha radioligand therapy

Study groups in NCT07214961
Study groupRoleWhat they receive
AB001 treated ¹⁷⁷Lu-PSMA naïve mCRPC patientsExperimentalDose Escalation will be initiated in ¹⁷⁷Lu-PSMA naïve mCRPC patients with the first cohort of participants receiving a starting dose of 100 MBq Pb212 (AB001) administered by slow injection on Day 1 of a 6-week (42-day) cycle. Four cycles of study treatment are planned; however, individual participants may continue up to a maximum of six treatment cycles provided they meet defined criteria. Subsequent cohorts of 177Lu-PSMA naïve participants will be opened for dose finding and schedule optimisation.
Receives: Drug: AB001
AB001 treated 177Lu-PSMA experienced mCRPC patientsExperimentalFor the 177Lu-PSMA experienced Group, the first cohort will initiate enrolment with a starting dose of 100 MBq Pb212 (AB001) administered by slow injection on Day 1 of a 6-week (42-day) cycle. Four cycles of study treatment are planned; however, individual participants may continue up to a maximum of six treatment cycles provided they meet defined criteria. Subsequent cohorts of 177Lu-PSMA experienced participants will be opened for dose finding and schedule optimisation.
Receives: Drug: AB001

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine the safety and tolerability profile of AB001 in participants with mCRPC

    Incidence and severity of TEAEs (including AESIs and TESAEs)

    Measured: From enrolment to active follow-up at 12 months post end of treatment

  2. Dose Escalation: To determine recommended AB001 Dose (MBq) in both 177Lu-PSMA naïve and 177Lu-PSMA experienced participants for Dose Expansion

    The recommended dose (MBq) of AB001 for dose expansion in 177Lu-PSMA naïve and experienced groups, determined based on safety and preliminary antitumour activity assessments (including incidence of DLTs and PSA50 response). The multiple measurements will be aggregated by the study team to select a single recommended dose.

    Single Outcome Measure Value (Units): Dose in MBq

    Measured: For 177Lu-PSMA naïve group: Anticipated after 20 evaluable participants; ~1 year from FPFV in this group. For 177Lu-PSMA experienced group: Anticipated after 20 evaluable participants, ~1 year from FPFV in this group

  3. Dose Escalation: To determine recommended AB001 Schedule (frequency of dose in cycles/weeks) in both 177Lu-PSMA naïve and 177Lu-PSMA experienced participants for Dose Expansion

    The recommended AB001 Schedule (frequency of dose in cycles/weeks) for dose expansion in 177Lu-PSMA naïve and experienced groups, determined based on safety and preliminary antitumour activity assessments (including incidence of DLTs and PSA50 response). The multiple measurements will be aggregated by the study team to select a single recommended AB001 Schedule.

    Single Outcome Measure Value (Units): AB001 Schedule in Cycles/weeks

    Measured: Time Frame- For 177Lu-PSMA naïve group: Anticipated after 20 evaluable participants; ~1 year from FPFV in this group. For 177Lu-PSMA experienced group: Anticipated after 20 evaluable participants, ~1 year from FPFV in this group

  4. Dose Expansion: To assess the recommended Dose (MBq) determined in Dose Escalation in both 177Lu-PSMA naïve and 177Lu-PSMA experienced participants for further clinical development of AB001

    The recommended dose (MBq) of AB001 for further clinical development of AB001 in 177Lu-PSMA naïve and experienced groups, determined based on safety and preliminary antitumour efficacy (including incidence and severity of [S]AEs, PSA50 response, and ORR). The multiple measurements will be aggregated by the study team to select a single recommended dose.

    Single Outcome Measure Value (Units): Dose in MBq

    Measured: In each group treated with selected dose, anticipated after 20 evaluable participants, ~1 year from FPFV in each group.

  5. Dose Expansion: To assess the recommended AB001 Schedule (frequency of dose in cycles/weeks) determined in Dose Escalation in both 177Lu-PSMA naïve and 177Lu-PSMA experienced participants for further clinical development of AB001

    The recommended schedule of AB001 for further clinical development of AB001 in 177Lu-PSMA naïve and experienced groups, determined based on safety and preliminary antitumour efficacy (including incidence and severity of [S]AEs, PSA50 response, and ORR). The multiple measurements will be aggregated by the study team to select a single recommended schedule of AB001.

    Single Outcome Measure Value (Units): AB001 Schedule in Cycles/weeks

    Measured: In each group treated with selected schedule, anticipated after 20 evaluable participants, ~1 year from FPFV in each group.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2025
  2. Study start3 Nov 2025
  3. Primary completion3 Nov 2027 (estimated)
  4. Study completion3 Nov 2028 (estimated)

Resources

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
This is an open-label, noncontrolled, multinational, multicentre, interventional Phase 1 clinical study of AB001 in patients with advanced mCRPC. The study includes the following main parts: Dose Escalation: To assess the safety and tolerability of AB001 and determine the recommended dose level and treatment schedule in both 177Lu-PSMA naïve and 177Lu-PSMA experienced groups to take into the Expansion part. Dose Expansion: To further characterise the antitumour activity and safety profile of the recommended dose and schedule in both 177Lu-PSMA naïve and 177Lu-PSMA experienced groups for further development of AB001 in specific patient populations. Dose Escalation will seamlessly progress into Dose Expansion. The study will include several sub-studies to enable characterisation of the biodistribution, body clearance, and PK of AB001 in participants with mCRPC.
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07214961
Sponsor's protocol ID
AB001-101
Other IDs
2024-516523-14
Acronym
ARTISAN
Status last verified
Apr 2026
First submitted
21 Jul 2025
Last updated
7 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: Decision regarding sharing of de-identified IPD will be made at a later date

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AB001 in people with Prostate Cancer (CRPC) and Metastatic Castrate Resistant Prostate Cancer (mCRPC), run by ARTBIO Inc. at 3 sites in United States.

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 9 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 7 Apr 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 United States. 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 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.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine the safety and tolerability profile of AB001 in participants with mCRPC (time frame: From enrolment to active follow-up at 12 months post end of treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07214961.

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 7 Apr 2026.

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