BAMF Health Clinical Trials

Protocol Title: A Multi-Center, Open-Label, Randomized Phase 3 Trial Comparing the Safety and Efficacy of 177Lu-PSMA-I&T versus Hormone Therapy in Patients with Metastatic Castration-Resistant Prostate Cancer

Short Name: ECLIPSE Trial

Sponsor: Curium

Description: This is a prospective, open-label, multi-center, randomized, Phase 3 study evaluating Lutetium 177Lu-PSMA-I&T as treatment compared to standard of care hormone therapy in men with metastatic Castration-Resistant Prostate Cancer.

The study will include a total of 400 patients with metastatic prostate cancer and documented positive PSMA PET imaging. Patients will be randomized at a ratio of 2:1 to receive either 177Lu-PSMA-I&T or hormone therapy (abiraterone or enzalutamide) respectively. Patients randomized to the investigational product will receive up to 4 treatments every 6 weeks at a dose of 200 mCi (7.4 GBq). All patients will be followed for adverse events and safety labs throughout the course of the study. Progression of disease will be assessed radiographically using Prostate Working Group Criteria 3 (PWGC3) and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of conventional imaging as well as PSA levels and symptom recording throughout the course of treatment.

30 patients will participate in a pharmacokinetic and radiation dosimetry sub-study at selected participating clinical sites. Sub-study participants will receive SPECT imaging after each treatment cycle for dosimetry analysis. Sub-study participants will not be randomized.

Patient Enrollment at BAMF: September 12, 2022

Number of patients to be enrolled (study wide): 400

Number of clinical sites in the US: 25 at present

Patient Eligibility Criteria: please click here to see the complete list

To get more information or be connected to discuss this clinical trial with someone at BAMF Health, please complete this form

Protocol Title: 64Cu-SAR-BBN for Identification of Participants With Recurrence of Prostate Cancer (SABRE)

Short Name: SABRE Trial

Sponsor: Clarity

Description: The aim of this study is to determine the safety and efficacy of 64Cu-SAR-BBN and determine the ability of 64Cu-SAR-BBN Positron emission tomography (PET)/computed tomography (CT) to correctly detect the recurrence of prostate cancer in participants with PSMA-negative biochemical recurrence of prostate cancer following definitive therapy.

Patient Enrollment at BAMF: January 12, 2023

Number of patients to be enrolled (study wide): 50

Number of clinical sites in the US: 8 at present

Patient Eligibility Criteria: please click here to see the complete list

To get more information or be connected to discuss this clinical trial with someone at BAMF Health, please complete this form

Protocol Title: Study of [68Ga]FAPI-46 PET in Patients With Pancreatic Ductal Carcinoma (FAPI-46 PDAC)

Sponsor: SOFIE Biosciences

Description: This is a prospective, multi-center, single arm, open label, non-randomized study to evaluate the ability of [68Ga]FAPI-46 to detect FAP expressing cells in patients with resectable or borderline resectable PDAC. The [68Ga]FAPI-46 PET scans will be acquired after initial staging using institutional standard methods. If the participant is prescribed neoadjuvant therapy, a second [68Ga]FAPI-46 PET scan will be performed within 21 days prior to planned surgical resection. This will be followed by histopathology and IHC analyses and comparison to resected PDAC tumor specimens.

Patient Enrollment at BAMF: Estimated for June 1, 2023

Number of patients to be enrolled (study wide): 60

Number of clinical sites in the US: 4 at present

Patient Eligibility Criteria:  please click here to see the complete list (https://clinicaltrials.gov/ct2/show/NCT05262855)

To get more information or be connected to discuss this clinical trial with someone at BAMF Health, please complete this form