Tomorrow’s Breakthroughs Today

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: A Phase 0 Multicenter Imaging Study of Hormone Receptor Negative (HR−) and Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Cancer Using Somatostatin Receptor (SSTR)-targeted PET Imaging.

Description: This imaging study aims to estimate the frequency of somatostatin receptor (SSTR) expression in hormone receptor negative (HR−) and human epidermal growth factor receptor 2 positive (HER2+) metastatic breast cancer with SSTR-targeted positron emission tomography (PET) imaging.

Each participant with metastatic HR− and HER2+ breast cancer will be enrolled to undergo a single timepoint SSTR-targeted PET/CT or PET/MRI using commercially available and FDA approved SSTR-targeted PET radiopharmaceuticals, i.e., gallium-68 (68Ga) labeled DOTATATE (68Ga-DOTATATE) or copper-64 (64Cu) labeled DOTATATE (64Cu-DOTATATE). Uptake in the metastatic lesions as well as healthy background organs (blood pool, breast tissue, liver, spleen) will be evaluated locally by the participating study sites.

Patient Enrollment at BAMF: April 2025

Number of patients to be enrolled (study wide): 37

Patient Eligibility Criteria:

Inclusion Criteria:

Female and male participants must meet all the following criteria for enrollment in the study:

1. At least 18 years old at the time of signing the informed consent form (ICF).
2. Biopsy proven HR− (defined as <1% of tumor cells stain positive for ER and PR on immunohistochemistry [IHC] or, if no percentage is available, then an Allred IHC score of ≤2) and HER2+ (defined as IHC score of 3 or IHC score of 2 with positive in situ hybridization [ISH]) metastatic breast cancer.
3. At least one RECIST v1.1-measurable tumor lesion on conventional imaging (CT or MRI) within 90 days of planned SSTR-targeted PET imaging.
4. For women of childbearing potential (WOCBP):

Negative serum or urine pregnancy test within 48 hours of SSTR-targeted PET.

A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥12 continuous months of amenorrhea [no menstrual bleeding of any kind, including menstrual period, irregular bleeding, spotting, etc.] with no identified cause other than menopause), and has not undergone surgical sterilization (total hysterectomy, or bilateral tubal ligation or bilateral oophorectomy) at least 6 weeks before SSTR-targeted PET.

5. Willingness and ability to read and/or understand the details of the study and provide written informed consent prior to any study-specific assessments and procedures commence.

Exclusion Criteria:

Participants who meet any of the following criteria will be excluded from the study:

1. Known allergy/hypersensitivity to 68Ga, 64Cu, octreotate, or any of the excipients of 68Ga/64Cu-DOTATATE.
2. Unable to tolerate PET/CT or PET/MRI scan.
3. Current use of high-dose glucocorticoids (≥20 mg prednisone per day or equivalent) within 14 days prior to SSTR-targeted PET. Inhaled or topical steroids, and steroids as premedication for imaging scans with contrast are permitted.
4. Use of long-acting SSTR-targeting agents (example: lanreotide) within 28 days of SSTR-targeted imaging.
5. Use of short-acting SSTR-targeting agents (example: sandostatin) with 24 hours of SSTR-targeted imaging.
6. Concurrent primary malignancy other than breast cancer, except adequately treated carcinoma in situ, non-melanoma carcinoma of the skin, or any other curatively treated malignancy that has achieved CR and shows no evidence of disease within 90 days of SSTR-targeted PET scan.
7. Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.
8. Pregnancy or breastfeeding.
9. Unable or unwilling to comply with the requirements of the study protocol.

If you are interested in more information about this trial, read our article or 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: 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.

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

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

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: 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

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: 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