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

NCT07214961 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: AB001-1012024-516523-14
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief 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. 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

Conditions

Prostate Cancer (CRPC); Metastatic Castrate Resistant Prostate Cancer (mCRPC)

Keywords

radioligand therapy; Pb-212; castrate-resistant prostate cancer; alpha particles; metastatic; mCRPC; Lu-177

Outcome Measures

Primary Outcomes (5)

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

  Incidence and severity of TEAEs (including AESIs and TESAEs)

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

• 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

  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

• 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

  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

• 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

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

• 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

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

Study Arms (2)

AB001 treated ¹⁷⁷Lu-PSMA naïve mCRPC patients

EXPERIMENTAL

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.

Drug: AB001

AB001 treated 177Lu-PSMA experienced mCRPC patients

EXPERIMENTAL

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.

Drug: AB001

Interventions

AB001 DRUG

Pb-212 PSMA targeted alpha radioligand therapy

AB001 treated 177Lu-PSMA experienced mCRPC patients; AB001 treated ¹⁷⁷Lu-PSMA naïve mCRPC patients

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Lu-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

You may not qualify if:

• 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

Sponsors & Collaborators

• ARTBIO Inc.: lead

Study Sites (3)

BAMF Health

Grand Rapids, Michigan, 49503, United States

RECRUITING

XCancer

Omaha, Nebraska, 68130, United States

RECRUITING

United Theranostics

Princeton, New Jersey, 08540, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• CMO

  ARTBIO Inc.

  STUDY CHAIR

Central Study Contacts

Snr Director, Clinical Operations

CONTACT

+16178525700; trials@artbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: October 9, 2025
• Study Start: November 3, 2025
• Primary Completion (Estimated): November 3, 2027
• Study Completion (Estimated): November 3, 2028
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

US (3)