BAMF RadioNexus

Protocol Title A Study to Investigate LY4257496 in Adults with GRPR-Positive Advanced Solid Tumors. Phase: 1a/1b

Sponsor: Eli Lilly and Company

Description: This is a Phase 1a/b multicenter, open-label trial of LY4257496, a GRPR-targeted radioligand therapy, in adults with GRPR-positive advanced solid tumors (OMNIRAY). The trial will evaluate safety, tolerability, and efficacy of LY4257496 as monotherapy and as part of relevant SOC combination therapy in participants with GRPR-positive advanced solid tumor types, including Breast, Colorectal, Prostate and Endometrial cancer.

GRPR-positive disease will be defined by GRPR imaging at screening.

Brief Summary: Phase 1a will enroll up to 135 participants, Phase 1b will enroll up to 286 participants, both phases will include : Breast, Colorectal, Prostate and Endometrial cancer.

Patient Enrollment at BAMF: Mid-November 2025

Number of patients to be enrolled (study wide): 421 Patients. Patient Eligibility Criteria: Please click here to see the complete list at ClinicalTrials.Gov

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

Protocol Title: An Open-Label, Single Dose, Single Arm, Multicenter Phase 2b Study to Establish the Imaging Performance of RAD101 Positron Emission Tomography (PET) in Participants with Suspected Recurrent Brain Metastases from Solid Tumors (GCP-PRT-101-001)

Sponsor: Radiopharm Theranostics Ltd.

Description: Contact BAMF for more information

Patient Enrollment at BAMF: Actively enrolling

Number of patients to be enrolled (study wide): N/A

Patient Eligibility Criteria: Contact BAMF for more information

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

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

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

Protocol Title: A Phase 1/2a Dose Escalation and Expansion Study of the Safety, Tolerability, and Preliminary Clinical Activity of 177LuBetaBart, a 177Lu-Labeled Anti-B7-H3 Monoclonal Antibody, in Patients with Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors

Sponsor: Radiopharm Theranostics Ltd. (RAD)

Description: The purpose of this study is to establish the safety profile, biodistribution, pharmacokinetics (pk), and radiation dosimetry of 177Lu-BetaBart, to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D), and to evaluate preliminary anti-tumor activity in select patient populations.

The study is divided into 2 phases. Phase 1 is the dose escalation phase. Phase 2a is the dose expansion phase. Each phase consists of a Screening Period, a Treatment and Imaging Period, and a Safety and Long-term Follow-up Period.

Trial population: Participants ≥ 18 years of age with castration-resistant prostate cancer (CRPC), colorectal cancer (CRC), non-small-cell lung cancer (NSCLC), small-cell lung cancer (SCLC), head and neck squamous cell carcinoma (HNSCC), ovarian cancer, cervical cancer, endometrial cancer, triple negative breast cancer (TNBC), or esophageal squamous cell carcinoma (ESCC) who have documented disease progression during or after their most recent line of anticancer therapy will be eligible to enroll. CRC will be capped at 33% of enrollment per cohort.

Patient Enrollment at BAMF: Trial will be active and enrolling in November 2025

Number of patients to be enrolled (study wide): 61

Patient Eligibility Criteria: Please click here to see the complete list at ClinicalTrials.Gov

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

Protocol Title: Imaging and Biodistribution of [18F]FAPI-74 in Endometriosis Using PET/MRI

Sponsor: BAMF Health

Description:
This is a single-site exploratory research study, not a clinical trial, aimed at providing an initial understanding of the diagnostic potential of [18F]FAPI-74 PET-MRI scans for identifying ectopic endometrial lesions. The study will include up to 5 women with suspected endometriosis, aged 18-45, who are already scheduled for surgery to confirm the diagnosis. Participants will undergo one PET/MRI imaging session at BAMF Health before surgery. This imaging approach aims to identify and localize endometriotic lesions more accurately than current diagnostic methods.

Screening assessments will confirm eligibility before enrollment. Participants will receive a single injection of [18F]FAPI-74 before the PET/MRI scan. A follow-up phone call will occur 24-72 hours after the imaging session to monitor for any side effects.

Patient Enrollment at BAMF: Recruiting now

Number of patients to be enrolled (study wide): 10

Patient Eligibility Criteria: view patient eligibility criteria here

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

Protocol Title: A single arm, open-label Phase 1/1b study of the theranostic pair RYZ811 (diagnostic) and RYZ801 (therapeutic) to identify and treat subjects with GPC3+ unresectable HCC

Sponsor: RayzeBio, Inc.

Description: To determine the recommended phase 2 dose (RP2D) of RYZ801 in subjects with GPC3+ unresectable HCC (Dose Escalation only). To assess the safety and tolerability of RYZ801 in subjects with GPC3+ unresectable HCC. Safety and tolerability of RYZ801 as measured by incidence and severity of AEs, including SAEs, laboratory changes, and other safety findings.      To assess the safety and tolerability of RYZ811 in subjects with unresectable HCC. Safety and tolerability of RYZ811 as measured by incidence and severity of AEs, including SAEs, laboratory changes, and other safety findings. To evaluate the biodistribution of RYZ811 in subjects with unresectable HCC. SUV (mean, maximum and peak) of organs and tumors; volume of RYZ811 avid uptake in tumor lesions; and tumor-to-normal organ tracer uptake ratios.

Key Inclusion Criteria:

Age of at least 18 years at the time of signing the informed consent form (ICF)

Histologically/cytologically confirmed diagnosis of HCC.

At least 1 prior systemic therapy for unresectable HCC

Key Exclusion Criteria:

Subjects with fibrolamellar carcinoma, sarcomatoid HCC or combined hepatocellular cholangiocarcinoma

Prior liver transplantation or candidates for liver transplantation

Documented hepatic encephalopathy

Prior EBRT to the liver

Prior liver radioembolization

Patient Enrollment at BAMF: Actively enrolling

Number of patients to be enrolled (study wide): ~70

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

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

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.

Protocol Title: A Phase 1 Safety and Feasibility Study of [¹¹¹In]In-ART-101 in Men with Metastatic Castrate-resistant Prostate Cancer

Sponsor: Archeus Technologies

Description: This is a phase 1 safety and feasibility SPECT/CT imaging study of [¹¹¹In]In-ART-101 in approximately 10 participants with mCRPC who are candidates to receive radioligand therapy with [¹⁷⁷Lu]Lu-PSMA-617 (Pluvicto). While there is no anticipated clinical benefit to participants enrolled in this study, verification in human participants of the biodistribution characteristics of ART- 101 observed in preclinical studies could result new imaging or therapeutic agents, which could potentially benefit future patients.

Each patient will undergo a total of eight SPECT/CT scans, with four scans after [¹¹¹In]In-ART-101 administration and four scans after [¹⁷⁷Lu]Lu-PSMA-617.  Participation in the study will last approximately two months across the screening, study treatment, and follow-up periods.

Patient Enrollment at BAMF: Mid-June 2025

Number of patients to be enrolled: ~10

Patient Eligibility Criteria:

-Patient must be diagnosed with metastatic castration-resistant prostate cancer and be a candidate to receive radioligand therapy with [177Lu]Lu-PSMA-617.

-Patient must have had a PSMA-positive PET/CT within 8 weeks prior to being enrolled with scans available.

-Patient must not be undergoing other concurrent cytotoxic chemotherapy, immunotherapy, radiopharmaceutical therapy, or investigational therapy

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

Protocol Title: Minimizing CT Radiation in Total-Body PET-CT: A Head-to-Head Comparison of Low- Vs Standard-Dose CT for PSMA Imaging in Prostate Cancer

Sponsor: BAMF Health

Description: In this pilot study, BAMF Health is using the United Imaging uEXPLORER total-body PET-CT scanner along with AI Image Reconstruction (AIIR) software. The goal is to test new protocols that can lower radiation exposure from the CT portion of a scan to 22% or less, compared to traditional PET-CT scanners.

The integration of AIIR for CT dose reduction presents a pioneering approach to better understand a patient’s disease and enhance patient safety, particularly for those requiring frequent scans, such as patients with chronic conditions or cancer, thereby potentially reshaping diagnostic standards in healthcare

As a part of their standard of care imaging, patients in this study will receive the ordered PET tracer through an IV, following BAMF Health’s strict clinical policies. After the injection, a whole-body PET-CT scan will be performed using both the standard and reduced radiation doses.

Patient Enrollment at BAMF: Actively enrolling

Number of patients to be enrolled (study wide): ~30

Patient Eligibility Criteria: To be eligible to participate in this study, an individual must meet all the following criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Age ≥ 18 years of age
4. Referred to BAMF Health for PSMA PET-CT imaging for standard medical care
5. No serious co-morbidities, serious disease, severe claustrophobia or pain that in the opinion of the investigators, and/or physician of record could compromise participant safety, protocol objectives, and/or ability to remain still in supine position for duration of imaging.

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

Protocol Title: Phase I/II, open-label, multi-center study of [225Ac]Ac-PSMA-R2 in men with metastatic hormone sensitive prostate cancer (mHSPC) and in men with heavily pre-treated PSMA positive metastatic castrate resistant prostate cancer (mCRPC), with or without prior 177Lu-labelled PSMA-targeted radioligand therapy

Sponsor: Novartis Pharma.

Description: The study contains three groups (Group 1, Group 2, and Group 3). Each group has a dose escalation part which may be followed by a dose expansion part. The dose escalation parts in each group will establish the maximum tolerated dose or the recommended dose for expansion (MTDs/RDEs) of the 225Ac-PSMA-R2.

Dose escalation decisions will be made by the Investigators and Novartis during dose escalation meetings (DEMs) based on safety and tolerability information. The dose expansion parts in each group group/dosing schedule will assess the anti-tumor activity in the mHSPC and mCRPC populations.

Key Inclusion Criteria:

1. Evidence of PSMA-positive disease by 68Ga-PSMA-11 PET/CT
2. Documented progressive mCRPC or mHSPC
3. Adequate organ function
4. Patients with mHSPC who are treatment naïve or minimally treated’
5. Prior orchiectomy or ongoing ADT and should have received prior 177Lu-PSMA-RLT (Group1 dose escalation & expansion) or never received 177Lu-PSMA-RLT (Group 2 and Group 3 dose escalation & expansion).

Patient Enrollment at BAMF: Actively enrolling

Number of patients to be enrolled (study wide): ~200

Patient Eligibility Criteria: Please click here to see a detailed list at ClinicalTrials.gov

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

Protocol Title: An Open-label, Multicenter Phase 1/2 Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biodistribution and Antitumor Activity of the Alpha Radioligand Therapy AB001 in Patients with Metastatic Castration Resistant Prostate Cancer (mCRPC)

Sponsor: ARTBIO

Description: This is a Phase 1/2 dose escalation study to investigate if participants with advanced mCRPC can be treated with AB001 with an acceptable safety profile and expected positive benefit/risk ratio, and to obtain preliminary data on antitumor activity.

The dose escalation design will allow determination of the recommended dose and treatment schedule of AB001, for further evaluation and refinement during the dose expansion part of the trial. Furthermore, evaluation will be undertaken of the biodistribution, pharmacokinetics (PK), and body clearance for AB001 to support development of this ART.

Dose Escalation: The number of participants treated is estimated to be approximately 30.

Dose Expansion: Two separate Groups (A and B) of 30 participants each will be treated.

Patient Enrollment at BAMF: actively enrolling

Number of patients to be enrolled (study wide): 90

Patient Eligibility Criteria Contact BAMF Health for more information

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

Protocol Title: A Phase I/IIa theranostic study of 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for identification and treatment of PSMA-expressing metastatic castrate resistant prostate cancer.

Sponsor: Clarity Pharmaceuticals Ltd.

Description: This is a multi-center, open-label, non-randomized, dose-escalation, dose finding, cohort expansion study of 64Cu-SAR-bisPSMA and 67Cu-SARbisPSMA administered to participants with metastatic castrate resistant prostate cancer (mCRPC).

BAMF Health will be enrolling into both groups of the Cohort Expansion Phase: Main and Enzalutamide

Patient Enrollment at BAMF: Trial will be active & enrolling October 2025

Number of patients to be enrolled (study wide): 24

Patient Eligibility Criteria: Please click here to see the complete list at ClinicalTrials.Gov

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

This is a multicenter, open-label, prospective Phase 1/2a study to assess safety and tolerability, establish dosimetry and to identify an optimal imaging dose (radioactivity and mass dose) and imaging time window of 64Cu-LNTH-1363S (64Cu Radiolabeled FAPi PET/CT Imaging Agent) and to compare its imaging biodistribution with FAP expression by immunohistochemistry (IHC) in patients with sarcomas or GIT cancers. The study will be conducted in 2 parts (Part 1 and Part 2).

Part 1 will include 12 evaluable patients with supposed FAP-expressing solid tumors (metastatic sarcomas).

Part 1 of the study will last approximately 3 weeks for each patient and includes a Screening Period (up to 14 days), a 1-day Intervention Period, and a Safety Follow-up Period (7 days post dose).

BAMF Health is currently only enrolling to Part 1 (Metastatic Sarcoma)

Patient Enrollment at BAMF: Actively enrolling

Number of patients to be enrolled (study wide): ~32 Patients study wide

Patient Eligibility Criteria: Please click here to see the complete list at ClinicalTrials.Gov

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

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

Protocol Title: NECTINIUM-2: A Phase 1b, 2-part, Multicenter, Single-arm, Open-label Study to Evaluate the Safety and Efficacy of a Nectin-4 Radiopharmaceutical ([225Ac]Ac-AKY-1189) in Patients with Previously Treated Locally Advanced or Metastatic Solid Tumors

Sponsor: Aktis Oncology

Description: This is a phase 1b, 2-part, multi-center, single-arm, open-label study to evaluate the safety, tolerability, dosimetry, and pharmacokinetics (PK) of [225Ac]Ac-AKY-1189 and/or [64Cu]Cu-AKY-1189 as well as the preliminary anti-tumor activity of [225Ac]Ac-AKY-1189 in patients with locally advanced or metastatic urothelial cancer (mUC) and Nectin-4-expressing locally advanced or metastatic solid tumors. The study will consist of two parts.

Part 1 dose escalation includes patients with metastatic urothelial cancer (mUC).

Part 2 dose expansion includes patients  with Metastatic Triple Negative Breast Cancer, HR+ Breast, Non-Small Cell Lung, Cervical, Colorectal, and  Head & Neck cancers

The Part 1 dose escalation portion will determine the maximum tolerated or maximum administrated dose (MAD) and the recommended Part 2 dose (RP2D) of [225Ac]Ac-AKY-1189 in ~30 patients with locally advanced or metastatic urothelial cancer. This will be followed by a dose expansion in Part 2 to evaluate the efficacy and safety of [225Ac]Ac-AKY-1189 at the RP2D in 3 cohorts of patients as described below.

BAMF Health is currently enrolling to Part 1 metastatic urothelial cancer (mUC)

Patients Enrollment at BAMF: ~150

Number of patients to be enrolled (study wide): Approximately 150 total

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.