LUTETIUM (177LU) VIPIVOTIDE TETRAXETAN for Metastatic castration-resistant prostate cancer

Inclusion criteria

• {"criterion_text":"- Participants must be adults ≥ 18 years of age."}
• {"criterion_text":"-Participants must have an ECOG performance status ≤ 1"}
• {"criterion_text":"-Participants must have histological confirmation of adenocarcinoma of the prostate."}
• {"criterion_text":"-Participants must be PSMA-positive per gallium (68Ga) gozetotide (also referred to as [68Ga]Ga-PSMA-11 or radiolabeled AAA517 and 68 Ga-PSMA-11) positron emission tomographic–computed tomographic (PET/CT) scans at baseline with at least 1 lesion showing intermediate or high uptake level (PSMA expression score 2 or 3 per PROMISE V2 criteria and no lesions meeting the size criteria as defined in the read rules showing PSMA expression scores 0 or 1 as determined by the central reader."}
• {"criterion_text":"-Participants must have a castrate level of serum/plasma testosterone (≤50 ng/dL or ≤1.7 nmol/L) either by pharmaceutical or surgical methods."}
• {"criterion_text":"-Participants must have progressed only once on prior second generation ARPIs (abiraterone, enzalutamide, darolutamide, or apalutamide)."}

Exclusion criteria

• {"criterion_text":"-Previous treatment with any of the following within 6 months of study enrollment: Strontium‑89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation"}
• {"criterion_text":"-Any previous radioligand therapy."}
• {"criterion_text":"-Prior treatment with cytotoxic chemotherapy for metastatic castration-resistant prostate cancer(mCRPC) (e.g., taxanes, platinum, estramustine, vincristine, methotrexate, etc.), immunotherapy or biological therapy [including monoclonal antibodies]. [Note: Taxane exposure (maximum 6 cycles) is allowed if 12 months have elapsed since completion of this therapy in pre-mCRPC setting. Prior treatment with sipuleucel-T is allowed]."}
• {"criterion_text":"-Any investigational agents within 42 days prior to the day of the first RLT treatment."}

Primary endpoints

• {"endpoint_text":"-Time activity curves (TACs) and absorbed radiation dose of AAA617 in organs.","definition_or_measurement_approach":""}
• {"endpoint_text":"-Incidence and severity of adverse events (AEs) and serious AEs (SAEs)","definition_or_measurement_approach":""}
• {"endpoint_text":"-AAA617 dose reductions, interruptions, discontinuations","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"-TACs and absorbed radiation doses of AAA617 in tumors","definition_or_measurement_approach":""}
• {"endpoint_text":"-Concentrations of AAA617 in blood over time and derived PK parameters from blood radioactivity data.","definition_or_measurement_approach":""}
• {"endpoint_text":"-ORR is defined as the proportion of participants with best overall response (BOR) of confirmed complete response (CR) or partial response (PR) per investigator assessment and according to PCWG3 modified-RECIST v1.1.","definition_or_measurement_approach":"ORR defined as proportion with BOR of confirmed CR or PR per investigator assessment according to PCWG3 modified-RECIST v1.1."}
• {"endpoint_text":"-DCR is defined as the proportion of CR, PR, stable disease or non-CR/non-PD per investigator assessment and according to PCWG3 modified-RECIST v1.1 assessment in soft tissue, lymph node, and visceral lesions.","definition_or_measurement_approach":"DCR defined as proportion of CR, PR, stable disease or non-CR/non-PD per investigator assessment and PCWG3 modified-RECIST v1.1 in specified lesion types."}
• {"endpoint_text":"-DOR is defined as the duration of time between the date of the first documented BOR (CR or PR) per investigator assessment according to PCWG3 modified-RECIST v1.1 and the date of first documented progression or death due to any cause.","definition_or_measurement_approach":"DOR defined as time from first documented BOR (CR or PR) to first documented progression or death."}
• {"endpoint_text":"-Radiographic progression free survival (rPFS) defined as the time from the date of first dose of study treatment to the date of the first documented radiographic disease progression as assessed by investigator and PCWG3 modified-RECIST v1.1 criteria or death due to any cause, whichever occurs first.","definition_or_measurement_approach":"rPFS defined as time from first dose to first documented radiographic progression per investigator and PCWG3 modified-RECIST v1.1 or death."}
• {"endpoint_text":"-Prostate specific antigen (PSA) response is defined as proportion of participants who achieve any decrease from baseline that is confirmed by a second PSA measurement ≥4 weeks. participants with any decrease in PSA will also be summarized by visit.","definition_or_measurement_approach":"PSA response defined as any decrease from baseline confirmed by a second PSA measurement ≥4 weeks; also summarized by visit."}
• {"endpoint_text":"-Overall survival is defined as the time from the first dose of study treatment to death due to any cause.","definition_or_measurement_approach":"Overall survival defined as time from first dose to death due to any cause."}
• {"endpoint_text":"-Changes in safety laboratory parameters, vital signs, electrocardiogram (ECG).","definition_or_measurement_approach":""}
• {"endpoint_text":"-Duration of exposure to AAA617 and dose intensity.","definition_or_measurement_approach":""}

Methods

• Patient recruitment and retention by Jumo Health USA Inc. (duty listed under sponsor third parties)

Spain

Earliest CTIS Part Ii Submission Date

29-07-2024

Latest Decision Or Authorization Date

20-10-2025

Processing Time Days

448

Number Of Sites

4

Number Of Participants

11

Netherlands

Earliest CTIS Part Ii Submission Date

02-10-2024

Latest Decision Or Authorization Date

24-09-2025

Processing Time Days

357

Number Of Sites

1

Number Of Participants

18

Germany

Earliest CTIS Part Ii Submission Date

23-08-2024

Latest Decision Or Authorization Date

24-09-2025

Processing Time Days

397

Number Of Sites

8

Number Of Participants

34

Primary sponsor

Full Name

Novartis Pharma AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

Icon Clinical Research Limited

Responsibilities

code: 1

Name

IQVIA Limited

Responsibilities

code: 13 / code: 1 / code: 3 (multiple entries for IQVIA Limited in third parties)

Name

Parexel International (IRL) Limited

Responsibilities

code: 12

Name

Syneos Health Inc.

Responsibilities

code: 1

Third parties

• {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Patient Reported Outcomes (PRO) and Electronic Patient Reported Outcomes (ePRO) – Formatting, Translations and Licensing.","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code: 6","organisation_type":"Non-Pharmaceutical company"}
• {"country":"France","full_name":"Kayentis","duties_or_roles":"Patient Reported Outcomes (PRO) and Electronic Patient Reported Outcomes (ePRO) – Management, Data Collection.","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"code: 13","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"code: 13","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"code: 1","organisation_type":"Pharmaceutical company"}
• {"country":"Spain","full_name":"GE Healthcare Unidad Central De Radiofarmacia De Galicia S.L.","duties_or_roles":"code: 14","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient travel reimbursement","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"code: 1","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"code: 12","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"Spain","full_name":"Advanced Accelerator Applications Molecular Imaging Iberica S.L.","duties_or_roles":"code: 14","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"code: 1","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"code: 3","organisation_type":"Pharmaceutical company"}
• {"country":"Spain","full_name":"Advanced Accelerator Applications Molecular Imaging Iberica S.L.","duties_or_roles":"code: 14","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Jumo Health USA Inc.","duties_or_roles":"Patient recruitment and retention","organisation_type":"Hospital/Clinic/Other health care facility"}