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Protocol Title: Phase I Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry, and Preliminary Activity of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers

Sponsor: Novartis Pharmaceuticals

Description: The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of [177Lu]Lu-NNS309 and the safety and imaging properties of [68Ga]Ga-NNS309 in patients aged ≥ 18 years with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), HR+/HER2- ductal and lobular breast cancer (BC), triple negative breast cancer (TNBC) and colorectal cancer (CRC).

The study will be done in two parts. The first part is called “escalation” and the second part is called “expansion”. In both parts of the study, patients will initially be imaged with a [68Ga]Ga-NNS309 positron emission tomography (PET)/ computed tomography (CT) or PET/magnetic resonance imaging (MRI) scan and will be evaluated for eligibility for [177Lu]Lu-NNS309 treatment. In the escalation part, different doses of [177Lu]Lu-NNS309 will then be tested to identify recommended dose(s) (RD(s)) for further evaluation. The expansion part of the study will examine the safety and preliminary efficacy of [177Lu]Lu-NNS309 at the RD(s) determined during the escalation part. The end of study will occur when at least 80% of the patients per disease group in the expansion part have completed the follow-up for disease progression or discontinued from the study for any reason, and all patients have completed treatment and the 36-month long-term follow-up period.

Patient Enrollment at BAMF: Early November 2024

Number of patients to be enrolled (study wide): 124

Patient Eligibility Criteria: please click here to see the complete list at ClinicalTrials.gov

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Protocol Title: Radiolabeled Perfusion to Identify Coronary Artery Disease Using Water To Evaluate Responses of Myocardial FLOW (RAPID-WATER-FLOW)

Sponsor: MedTrace Pharma A/S

Description: This a Phase 3, prospective, open-label, multicenter study of [15-O]-H2O injection for PET imaging of subjects with suspected CAD. Approximately 182 evaluable participants with suspected CAD referred for testing will be included in the study at approximately 10 study sites in the United States and Europe. Approximately 215 participants will be enrolled to account for an estimated 15% drop-out rate. Screening assessments will occur prior to enrollment to confirm eligibility. All participants will receive two doses of [15-O]-H2O as part of a single PET imaging session (one dose at rest and one during pharmacological stress with adenosine). A safety follow-up phone call will occur 24 ± 8 hrs after completion of the [15-O]-H2O scan.

Patient Enrollment at BAMF: Recruiting now

Number of patients to be enrolled (study wide): 215

Patient Eligibility Criteria: please click here to see the complete list on ClinicalTrials.gov

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Protocol Title: GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2

Sponsor: Y-mAbs Therapeutics

Description: Patients with Small Cell Lung Cancer, Sarcoma and Malignant Melanoma will be treated with GD2-SADA:177Lu-DOTA complex(The IMP is a two-step radioimmunotherapy, delivered as two separate products GD2-SADA and 177Lu-DOTA) to assess safety and tolerability.

This is a phase 1 dose-escalation single-arm, open-label, non-randomized, multi-center trial of the safety and tolerability of GD2-SADA:177Lu-DOTA complex in GD2 expressing solid tumors.  The trial is planned with three parts, A, B and C. Escalation in this trial will be based on a classical 3+3 trial design.

Part A is a GD2-SADA dose escalation phase, in which patients will receive one treatment cycle.

Part B is a 177Lu-DOTA dose escalation phase, in which patients will receive up to 2 treatment cycles .

Part C is a repeated dosing phase where the doses determined in Part A and B will be administered. Patients will receive repeated treatment cycles with a maximum of 5 cycles.

Patient Enrollment at BAMF*: Open to enrollment

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

Patient Eligibility Criteria: please click here to see the complete list on ClinicalTrials.gov

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*This trial is conducted in collaboration with Corewell Health™ and the Corewell Health™ Haworth Innovative Therapeutics Clinic.  If you complete the interest form, we may provide your information to their staff

Title: A Phase I/IIa First-in-Human Study of [212Pb]VMT-α-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors

Sponsor: Perspective Therapeutics

Description: This is a prospective, multi-center open-label dose escalation, dose expansion study of [212Pb]VMT-α-NET in up to 160 adult subjects with unresectable or metastatic SSTR2-expressing neuroendocrine tumors (NETs) who have not received prior peptide receptor radionuclide therapy (PRRT).

The radioactivity dose escalation period (Phase I) tests up to 4 escalating radioactivity dose cohorts of up to 8 subjects (administered at approximately 8-week intervals) at the assigned cohort radioactivity dose.

Pre-specified dose adjustments and individual stopping rules for repeat treatment cycles are based on observed dose-limiting toxicities (DLTs) and adverse events (AEs).

Additionally, up to 40 subjects may be enrolled in each of the cohorts.

The Maximum Tolerated Dose (MTD) will be determined based on observed DLTs within 42 days of the first treatment cycle.

The recommended expansion (Phase IIa) dose(s) will be determined following a holistic analysis of observed DLTs, AEs, estimated cumulative organ radiation exposure, and efficacy signals over the course of all treatment cycles for all dose cohorts.

If MTD can not be identified within the 4 radioactivity dose cohorts, a Maximum Feasible Dose (MFD), incorporating manufacturing and logistical considerations for [212Pb]VMT-α-NET production, may be determined.

Up to 120 subjects will be considered for enrollment in the dose-expansion phase (Phase IIa) with approximately 100 subjects with GEP-NETs, approximately 10

subjects with bronchial NETs [small cell lung cancer], and approximately 10 subjects with pheochromocytoma or paragangliomas)

Reno-protective amino acids will be co-administered in a separate IV line prior to each [212Pb]VMT-α-NET dose in all subjects. Escalation will be based on a modified toxicity probability interval design [mTPI-2] until MTD is identified or the pre-specified rules are met.

A lead-in dosimetry sub-study will be conducted during the dose escalation period in which all subjects in the first two dose cohorts will undergo dosimetric evaluation prior to receiving the therapeutic agent.

Patient Enrollment at BAMF: recruiting now

Number of patients to be enrolled (study wide): 280

Patient Eligibility Criteria: please click here to see the complete list on ClinicalTrials.gov

If you are interested in more information about this trial, please fill out this form.

If you are interested in more information about this trial, please fill out this form

Protocol Title: Expanded Access Treatment With [Lu-177]-PNT2002 for Adult Patients With Prostate-Specific Membrane Antigen (PSMA)-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Sponsor: Lantheus Medical Imaging, Inc.

Description: The purpose of this program is to provide access to [Lu-177]-PNT2002 to patients who have been diagnosed with prostate-specific membrane antigen (PMSA)-positive castration-resistant prostate cancer (mCRPC). Patients must have received at least 1 prior androgen pathway inhibitor (ARPI) and cannot be treated by currently available drugs or clinical trials.

In this program participants will be administered [Lu-177]-PNT2002 intravenously every 8 weeks (about every 2 months) for 4 cycles, or 8 months of total treatment. During treatment, participants will be monitored with routine laboratory tests such as:

• Hematology blood tests
• Clinical Chemistry blood tests
• Testosterone/Prostate Antigen levels blood test
• Vital signs
• Imaging
• ECG

Patient Enrollment at BAMF: Recruiting Now

Number of patients to be enrolled (study wide): 250

Patient Eligibility Criteria: please click here to see the complete list on ClinicalTrials.gov

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Protocol Title: A Phase I/II Theranostic Study of 64Cu-SAR-BBN and 67Cu-SAR-BBN for Identification and Treatment of GRPR-expressing Metastatic Castrate Resistant Prostate Cancer in Patients Who Are Ineligible for Therapy With 177Lu-PSMA-617

Short Name: COMBAT Trial

Sponsor: Clarity Pharmaceuticals Ltd

Description: The aim for this study is to determine the safety and efficacy of 67Cu-SAR-BBN in participants with Gastrin Releasing Peptide Receptor (GRPR)-expressing metastatic castrate resistant prostate cancer in patients who are ineligible for therapy with 177Lu-PSMA-617.

Patient Enrollment at BAMF: Recruiting Now

Number of patients to be enrolled (study wide): 38 participants

Patient Eligibility Criteria: please click here to see the complete list on ClinicalTrials.gov

If you are interested in more information about this trial, please fill out this form.

Protocol Title: A Phase 4 Open-Label Multicenter Study of PYLARIFY® PET/CT or PET/MRI in Men With Newly Diagnosed Favorable Intermediate Risk (FIR) Prostate Cancer

Sponsor: Lantheus Medical Imaging

Description: The purpose of this study is to learn whether PYLARIFY® PET imaging (study scan) can safely and accurately detect the presence or absence of prostate cancer growing beyond the prostate gland in men with favorable intermediate risk prostate cancer.

Participants will receive a single dose of PYLARIFY® injection followed by a single whole-body PET/CT or PET/MRI scan acquired at 1 to 2 hours after PYLARIFY injection. Participants with positive study scan results that are suspicious for prostate cancer outside of the prostate gland may be asked to undergo additional diagnostic test(s) and/or recommend certain treatment(s) for prostate cancer within 2 to 90 days after the study scan. Participants will be monitored for up to 12 months to collecting information about treatment they receive for prostate cancer and results of regular PSA blood draws if ordered by doctors for up to 12 months after the study scan.

Patient Enrollment at BAMF: Open to enrollment

Number of patients to be enrolled (study wide): 274

Patient Eligibility Criteria: please click here to see the complete list on ClinicalTrials.gov

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Protocol Title: A Phase 2/3, Randomized, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of FPI-2265 (225Ac-PSMA-I&T) in Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC), Previously Treated With 177Lu-PSMA Radioligand Therapy (RLT)

Sponsor: Fusion Pharmaceuticals Inc.

Description: This is an open-label, randomized, multicenter study of FPI-2265 (225Ac-PSMA-I&T). The dose optimization Phase 2 part will be investigating the safety, tolerability, and anti-tumor activity of novel dosing regimens of FPI-2265 in participants with PSMA-positive mCRPC who have been previously treated with 177Lu-PSMA-617 or another 177Lu-PSMA radioligand therapy (RLT).

The purpose of the dose optimization segment (Phase 2) is to determine the recommended FPI-2265 dose and regimen. Conclusions from Phase 2 will be based on safety, tolerability, and anti-tumor activity.

Participants with PSMA positive scans will be randomized (1:1:1) to one of three different dosing arms:

Arm 1: Will consist of nine doses of FPI-2265, administered every four weeks at 50 kBq/kg.

Arm 2: Will consist of six doses of FPI-2265, administered every six weeks at 75 kBq/kg.

Arm 3: Will consist of four doses of FPI-2265, administered every eight weeks at 100 kBq/kg.

Participants will be monitored and assessed for efficacy response, disease progression and adverse events.

Patient Enrollment at BAMF: Open to enrollment

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

Patient Eligibility Criteria: please click here to see the complete list on ClinicalTrials.gov 

If you are interested in more information about this trial, please fill out this form.

Protocol Title: Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy: A Prospective, Single-arm, Multi-center, Blinded-review, Phase 3 Diagnostic Performance Study

Sponsor: Clarity Pharmaceuticals

Description: The aim for this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.

Patients must have the following to be included in the trial:

• Untreated, histologically confirmed adenocarcinoma of the prostate.
• High-risk or greater PC defined by National Comprehensive Cancer Network Guidelines Version 1.202327 (clinical stage ≥T3a, or Grade Group ≥4, or PSA >20 ng/mL).
• Patients electing to undergo radical prostatectomy with pelvic lymph node dissection.

Patient Enrollment at BAMF: Open to enrollment

Number of patients to be enrolled (study wide): 383

Patient Eligibility Criteria: please click here to see the complete list on ClinicalTrials.gov

If you are interested in more information about this trial, please fill out this form.

Protocol Title: An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC (PSMA-DC)

Sponsor: Novartis Pharmaceuticals

Description: The purpose of this study is to evaluate the efficacy and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) in participants with oligometastatic prostate cancer (OMPC) progressing after definitive therapy to their primary tumor. The data generated from this study will provide evidence for the treatment of AAA617 in early-stage prostate cancer patients to control recurrent tumor from progressing to fatal metastatic disease while preserving quality of life by delaying treatment with androgen deprivation therapy (ADT).

All participants will be assessed for eligibility and will undergo baseline disease assessments including a mandatory gallium (68Ga) gozetotide (also known as [68Ga]Ga-PSMA-11) or piflufolastat (18F) (also known as [18F]DCFPyL) PET/CT scan and conventional imaging (i.e., CT/MRI and bone scans). Piflufolastat (18F) PET/CT scan will be performed in countries where it is approved. Stereotactic Body Radiation Therapy (SBRT) will be administered to all metastatic Prostate Cancer (PC) lesions after randomization and before the start of treatment with AAA617 or observation.

• The duration of SBRT procedures is approximately 3 weeks.
• For participants randomized to the investigational arm (AAA617), the treatment duration will be up to 4 cycles of AAA617. For participants randomized to the control arm (observation) the treatment duration will end at the last fraction of SBRT administration.
• The visit frequency will be every week 1 and 3 of each of the 4 cycles and every 16 weeks thereafter (for both arms) until first event of disease progression (RECIST 1.1)
• The study duration is approximately 6.5 years.

Patient Enrollment at BAMF: Open to Enrollment

Number of patients to be enrolled (study wide): 450

Patient Eligibility Criteria: please click here to see the complete list on ClinicalTrials.gov

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Protocol Title: Study of RYZ101 in Combination With SoC in Subjects With SSTR+ ES-SCLC

Sponsor: RayzeBio, Inc.

Description: This Phase 1b study aims to determine the safety, preliminary antitumor activity, and pharmacokinetics (PK) of RYZ101 in combination with standard of care (SoC) therapy consisting of carboplatin + etoposide + atezolizumab in untreated subjects with somatostatin receptor expressing (SSTR+) ES-SCLC.

Patient Enrollment at BAMF*: Open to enrollment

Number of patients to be enrolled (study wide): 31

Patient Eligibility Criteria: please click here to see the complete list on ClinicalTrials.gov

If you are interested in more information about this trial, please fill out this form.

*This trial is conducted in collaboration with Corewell Health™.  If you complete the interest form, we may provide your information to their staff