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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-516523-14 | EudraCT Number |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AB001 | Drug | Pb-212 PSMA targeted alpha radioligand therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| CMO | ARTBIO Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BAMF Health | Grand Rapids | Michigan | 49503 | United States | ||
| XCancer |
Decision regarding sharing of de-identified IPD will be made at a later date
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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.
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| 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. |
| Omaha |
| Nebraska |
| 68130 |
| United States |
| United Theranostics | Princeton | New Jersey | 08540 | United States |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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