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

Phase 1Active Not RecruitingNCT07214961

ARTBIO Inc.80 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

BAMF Health

Grand Rapids, Michigan, United States

XCancer

Omaha, Nebraska, United States

United Theranostics

Princeton, New Jersey, United States

Outcomes

Primary Outcomes

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

Incidence and severity of TEAEs (including AESIs and TESAEs)

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 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

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 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: 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

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 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

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