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Clinical Trials at BAMF Health

We’re committed to making as many life-saving treatments available as possible. By partnering with other leading industry experts around the world, we’re able to rapidly test diagnostic tools and therapies for cancer, cardiovascular disease, neurodegenerative diseases, and more.

With our skilled team of researchers and clinicians at the helm, we prioritize patient safety and strive to deliver an unparalleled experience.

BAMF Health is currently recruiting for the following advanced clinical trials 

Small Cell Lung Cancer | RYZ101-101 Study of RYZ101 in Combination With SoC in Subjects With SSTR+ ES-SCLC

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 Criteriaplease click here to see the complete list

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

Small Cell Lung Cancer, Sarcoma, and Malignant Melanoma | Y-mAbs 1001 Trial GD2-SADA:177Lu-DOTA Complex in Patients With Solid Tumors Known to Express GD2

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 Criteriaplease click here to see the complete list

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

*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

Cardiovascular Imaging | RAPID-WATER-FLOW Radiolabeled Perfusion to Identify Coronary Artery Disease Using Water To Evaluate Responses of Myocardial FLOW (RAPID-WATER-FLOW)

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: Recruitment Expected Mid-March

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

Patient Eligibility Criteriaplease click here to see the complete list

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

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

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

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

Prostate Cancer | COMBAT Trial 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

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

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

Pancreatic Cancer | NMK89P101 Trial Assess safety, tolerability, pharmacokinetics, radiation dosimetry, and positron emission tomography (PET) imaging properties of 89Zr-labeled hNd2

Title: A Phase I trial to assess safety, tolerability, pharmacokinetics, radiation dosimetry, and positron emission tomography (PET) imaging properties of 89Zr-labeled hNd2 (NMK89) in patients with pancreatic cancer histologically positive for MUC5AC

Short Name: NMK89P101

Sponsor: Nihon Medi-Physics

Number of patients to be enrolled study wide: 10

Patient enrollment at BAMF: recruiting now

Patient eligibility criteria: Please click here to see the complete list.

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

Pancreatic Cancer | FAPI-46 Trial A Phase 2, Multicenter, Single Arm, Open Label Non-Randomized Study of [68Ga]FAPI-46 PET in Patients With Resectable or Borderline Resectable Pancreatic Ductal Carcinoma

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: Recruiting Now

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

Patient Eligibility Criteriaplease click here to see the complete list

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

Gastrointestinal Cancers | FAPI-74 Trial Assess efficacy of [18F]FAPI-74 to detect FAP expressing cells in patients diagnosed with gastrointestinal cancers

Title: A Phase 2, Multicenter, Single Arm, Open Label, Non-Randomized Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers

Short Name: FAPI-74 / 18FFAPI-2023P2

Sponsor: SOFIE

Description: This is a prospective, multi-center, open label, non-randomized clinical trial to assess efficacy of [18F]FAPI-74 to detect FAP expressing cells in patients diagnosed with gastrointestinal cancers, including hepatocellular carcinoma, cholangiocarcinoma, gastric, pancreatic and colorectal cancer. The [18F]FAPI-74 PET scan will be acquired in patients with proven GI cancers after initial staging using institutional standard methods. The PET scan results will be compared to FAP immunohistochemistry (as the primary objective) and histopathology (as the secondary objective) of the biopsied or resected tissues.

Number of patients to be enrolled study wide: 120

Patient enrollment at BAMF: recruiting now

Patient eligibility criteria: Please click here to see the complete list.

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

Adrenal Gland Disorders/Healthy volunteers | FNP-59 Trial Investigating if [18F]FNP-59 can be useful in capturing PET/CT images of the adrenal gland

Title: Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59

Short Name: FNP-59

Sponsor: University of Michigan

Description: We are trying to understand if an imaging agent (also known as a PET Tracer) called [18F]FNP-59 can be useful in taking pictures (PET/CT images) of the adrenal gland to help diagnose disorders.  The adrenal gland is a small organ that sits on top of each kidney. It produces hormones that are important for regulating blood pressure, blood sugar, and other bodily functions. This imaging agent is special because it doesn’t have the same risks as the current imaging agent, which can sometimes damage the thyroid gland. We hypothesize that [18F]FNP-59 will be more effective than current imaging at determining if there is an adrenal gland disorder and may prevent the need for more invasive procedures for patients.

  • Healthy volunteers and people with adrenal gland disorders are able to participate in this trial.
  • Healthy participants in this study will receive a medication by IV that will stimulate their adrenal gland and hormones, and then will receive an injection by IV the [18F]FNP-59 PET tracer and have multiple PET/CT scans.
  • Participants with Adrenal Gland Disorders will receive an injection by IV of [18F]FNP-59 and have multiple PET/CT scans.

Number of patients to be enrolled study wide: 24

Patient enrollment at BAMF: recruiting now

Patient eligibility criteria: Please click here to see the complete list

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

Future Clinical Trials

BAMF Health is working every day to bring on additional clinical trials opportunities to improve disease management using molecular imaging and molecularly targeted radiation therapy.

Please fill out this form if you are interested to receive updates when BAMF Health initiates a clinical trial that matches your interests.

Gastroesophageal, Pancreatic, and Glioblastoma Cancers | FF58 Trial A Phase I Study of [177Lu]Lu-FF58 in Patients With Advanced Solid Tumors

Protocol Title: A Phase I Study of [177Lu]Lu-FF58 in Patients With Advanced Solid Tumors

Sponsor: Novartis Pharmaceuticals

Description: The purpose of the study is to test the safety and dosing of [177Lu]Lu-FF58, a radioligand therapy for patients with advanced or metastatic tumors that express proteins known as integrins: alpha-v beta-3 integrin (αvβ3) and alpha-v beta-5 integrin (αvβ5). The study will also further characterize the radioligand imaging agent [68Ga]Ga-FF58 including its ability to identify tumor lesions and its safety profile.

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 be screened with a [68Ga]Ga-FF58 positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) scan to assess eligibility for treatment with [177Lu]Lu-FF58. In the escalation part, different doses of [177Lu]Lu-FF58 will be tested to identify the recommended dose. The expansion part of the study will examine the safety and preliminary efficacy of [177Lu]Lu-FF58 at the recommended dose determined during the escalation part. The end of study will occur when at least 80% of the patients 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, or the study is terminated early in which case all patients would also be followed up for safety.

Patient Enrollment at BAMF: Recruitment Expected in June

Number of patients to be enrolled (study wide): 116

Patient Eligibility Criteriaplease click here to see the complete list

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