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NCT Number: NCT07214961

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Prostate Cancer (CRPC) Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Metastatic Castrate Resistant Prostate Cancer (mCRPC) Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

BAMF Health, Grand Rapids, Michigan, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

Exclusion criteria

  • 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

Treatment and study plan

AB001

Drug

Pb-212 PSMA targeted alpha radioligand therapy

Primary outcomes

  1. 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

    Incidence and severity of TEAEs (including AESIs and TESAEs)

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

    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

    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

  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

    Time frame: 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

    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

  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

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

    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

  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

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

    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

Sponsors and collaborators

Lead sponsor

ARTBIO Inc.

Industry

Registry information

Official study 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

Acronym: ARTISAN

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Oct 9, 2025
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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