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

Clinicaltrials.gov ID: NCT07214961
db-list-check Status RECRUITING
b-loader Phase PHASE1
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 80

Conditions

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

Drugs

AB001

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

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

Study Chair

  • CMO

Eligibility Criteria

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 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

Study Plan

AB001 treated u00b9u2077u2077Lu-PSMA nau00efve mCRPC patients

EXPERIMENTAL

Dose Escalation will be initiated in u00b9u2077u2077Lu-PSMA nau00efve 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 nau00efve participants will be opened for dose finding and schedule optimisation.

  • DRUG:

    AB001

    Description:

    Pb-212 PSMA targeted alpha radioligand therapy

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

    Description:

    Pb-212 PSMA targeted alpha radioligand therapy

Outcome Measures

Primary Outcome Measures

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

Dose Escalation: To determine recommended AB001 Dose (MBq) in both 177Lu-PSMA nau00efve and 177Lu-PSMA experienced participants for Dose Expansion

Time Frame: For 177Lu-PSMA nau00efve 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 nau00efve and 177Lu-PSMA experienced participants for Dose Expansion

Time Frame: Time Frame- For 177Lu-PSMA nau00efve 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 nau00efve 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.

Dose Expansion: To assess the recommended AB001 Schedule (frequency of dose in cycles/weeks) determined in Dose Escalation in both 177Lu-PSMA nau00efve 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.

Timeline

  • Last Updated
    December 3, 2025
  • Start Date
    October 9, 2025
  • Today
    December 20, 2025
  • Completion Date ( Estimated )
    November 3, 2028

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