AB001 for Prostate Cancer

(ARTISAN Trial)

Recruiting at 3 trial locations

Overseen By Josh Needham-Clark

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: ARTBIO Inc.

Must be taking: Androgen deprivation

Must not be taking: Antidepressants, Corticosteroids

Disqualifiers: CNS metastases, Cardiac disease, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new treatment, AB001, for advanced prostate cancer. Researchers aim to assess the safety and tolerability of the treatment and determine the optimal dose and schedule. AB001 uses alpha particles to target and kill cancer cells, potentially leading to fewer side effects than other radiation therapies. This trial suits men with advanced prostate cancer who have already undergone hormone therapies and at least one chemotherapy. Participants must have a confirmed diagnosis of prostate cancer and show signs of disease progression. As a Phase 1 trial, this research focuses on understanding how AB001 works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop your current medications. However, you cannot have had certain cancer treatments or investigational therapies within four weeks before starting the study, and some medications like systemic corticosteroids above a certain dose are restricted. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that AB001 is likely to be safe for humans?

Research shows that AB001, a new treatment using radiation, is being tested for safety and effectiveness in treating prostate cancer. In earlier studies, patients who received AB001 showed promise in managing their cancer. However, since this is one of the first trials with people, detailed safety information is not yet available.

This treatment uses tiny particles called alpha particles to target and kill cancer cells while avoiding harm to healthy cells. This focused approach might lead to fewer side effects compared to other radiation treatments. However, as with any new treatment in early trials, researchers are still learning about all the possible side effects. Participants in the trial will help researchers understand how well people can tolerate AB001. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for metastatic castration-resistant prostate cancer (mCRPC) use hormonal therapy or chemotherapy to slow the cancer's growth. But AB001 works differently, targeting cancer cells with a radioactive isotope called Pb212, which is delivered directly to the tumor. This approach, known as targeted radiotherapy, can potentially minimize damage to healthy cells compared to traditional treatments. Researchers are excited about AB001 because it could offer a more precise and potentially more effective way to treat mCRPC, particularly for patients who haven't responded well to other therapies.

What evidence suggests that AB001 might be an effective treatment for prostate cancer?

Research has shown that AB001 could be promising for advanced prostate cancer. It targets a protein on cancer cells and delivers tiny particles that can kill these cells while leaving healthy tissue unharmed. Early studies in mice demonstrated that AB001 might be more effective at targeting cancer than similar treatments. Initial human studies also suggested that AB001 can be safely administered, with scans showing it reaches the cancer cells even at low doses. In this trial, participants will be divided into two groups: those who are ¹⁷⁷Lu-PSMA naïve and those who are ¹⁷⁷Lu-PSMA experienced. While more research is needed, these findings offer hope for AB001 as a new treatment option. ^{1 4 5 6 7}

Who Is on the Research Team?

Margaret Yu

Principal Investigator

ARTBIO Inc.

Are You a Good Fit for This Trial?

This trial is for patients with advanced prostate cancer that has spread and doesn't respond to hormone therapy. It's open to those who have or haven't tried a similar treatment using Lu-PSMA, which targets the same protein as AB001.

Inclusion Criteria

Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol

I am fully active or restricted in physically strenuous activity but can do light work.

I am a man aged 18 or older.

Exclusion Criteria

Human immunodeficiency virus (HIV) infection with specific criteria

Known allergies, hypersensitivity, or intolerance to the study treatment

Concurrent participation in the active part of another clinical study with investigational product(s)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Researchers test different doses of AB001 to find the safest and most effective dose

24-36 weeks

4-6 cycles of treatment, each cycle lasting 6 weeks

Dose Expansion

The selected dose is further evaluated to refine the treatment schedule and gather more data on its effectiveness and safety

24-36 weeks

4-6 cycles of treatment, each cycle lasting 6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• AB001

Trial Overview AB001, a new drug targeting prostate cancer cells by delivering alpha radiation directly to them, is being tested. The study will find the safest dose and best schedule through two phases: increasing doses first then expanding at the chosen dose.

How Is the Trial Designed?

Group I: AB001 treated ¹⁷⁷Lu-PSMA naïve mCRPC patients Experimental Treatment 1 Intervention

Dose 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.

Group II: AB001 treated 177Lu-PSMA experienced mCRPC patients Experimental Treatment 1 Intervention

For 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.

Who Is Running the Clinical Trial?

ARTBIO Inc.

Lead Sponsor

Trials

1

Recruited

3+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40081958/

First-in-Human Phase 0 Study of AB001, a Prostate- ... The 212 Pb-based radioligand AB001 was safely administered to mCRPC patients. γ-camera imaging of AB001 was feasible, even at a microdose, and demonstrated ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07214961

Study of Alpha Radioligand Therapy AB001 in Patients ... This study is designed to investigate the safety, tolerability, and effectiveness of a new treatment called AB001 in both 177Lu-PSMA naïve and 177Lu-PSMA ...

3. jnm.snmjournals.org jnm.snmjournals.org/content/early/2025/03/13/jnumed.124.269299/tab-figures-data

First-in-Human Phase 0 Study of AB001, a Prostate- ... First-in-Human Phase 0 Study of AB001, a Prostate-Specific Membrane Antigen–Targeted 212Pb Radioligand, in Patients with Metastatic Castration- ...

4. urologytimes.com urologytimes.com/view/fda-greenlights-phase-1-trial-of-alpha-radioligand-therapy-in-mcrpc

FDA greenlights phase 1 trial of alpha radioligand therapy ... AB001 is a novel PSMA-targeted radioligand therapy designed to treat metastatic prostate cancer with potentially higher tumor dose rates and ...

5. link.springer.com link.springer.com/article/10.1007/s00259-025-07330-y

Therapeutic evaluation of [ 212 Pb]Pb-AB001 and [ 177 Lu ... This study compared the efficacy of [ 212 Pb]Pb-AB001 and [ 177 Lu]Lu-PSMA-617 in a mouse model of disseminated prostate cancer.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12051763/

First-in-Human Phase 0 Study of AB001, a Prostate-Specific ... AB001, a 212 Pb-based PSMA-targeted α-alpha radioligand therapy, should be investigated in a therapeutic dose-finding clinical study.

7. urotoday.com urotoday.com/conference-highlights/esmo-2025/esmo-2025-prostate-cancer/164120-esmo-2025-tip-the-artisan-trial-phase-1-2-dose-escalation-and-expansion-of-ab001-in-patients-with-mcrpc.html

ESMO 2025: TiP – The ARTISAN Trial: Phase 1/2 Dose ... Oliver Sartor discussing the ARTISIAN trial, a phase 1/2 dose escalation and expansion trial of AB001 in patients with metastatic castration- ...