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Protocol Title: BActinium-1: A Phase 1b, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Intravenous Administration of a B7-H3 Radiopharmaceutical ([225Ac]Ac-AKY-2519) in Metastatic Castration-Resistant Prostate Cancer

Sponsor: Aktis Oncology, Inc.

Description: Up to 138 participants will be enrolled in Phase 1b, which will have two cohorts: A & B. The study will evaluate the safety, tolerability, dosimetry, and pharmacokinetics of [64Cu]Cu-AKY-2519 and [225Ac]Ac-AKY-2519, as well as the anti-tumor activity of [225Ac]Ac-AKY-2519 in participants with metastatic castration-resistant prostate cancer (mCRPC) with and without prior exposure to 177Lu-PSMA-617 (PLUVICTO™). There will also be a dose escalation phase that will determine the maximum tolerated dose [225Ac]Ac-AKY-2519 in up to 36 participants.

Number of patients to be enrolled (study wide): Up to 138 patients in Phase 1b

Up to 36 patients in the dose-escalation portion (about 18 per cohort)

Patient Eligibility Criteria:

Inclusion:

1. Age ≥ 18 years
2. Histologic or cytologic confirmation of prostatic adenocarcinoma
3. Participants must have documented disease progression on most recent prior line of therapy, either by PSA or imaging-based progression
4. Serum testosterone (<50 ng/dL)- as expected in this disease setting
5. Participants with a prior history of additional malignancy unrelated to enrollment in this study who have been disease-free for more than 1 year are eligible. If the risk of metastasis and death are negligible, participant is eligible regardless of time since diagnosis

Exclusion:

1. Treatment with more than 2 prior ARPIs and/or more than 1 prior taxane-based therapy in the mCRPC setting
2. Cytotoxic chemotherapy, targeted therapy, biologic agents, immunotherapy, or external beam-radiotherapy delivered within the 28 days prior to [225Ac]Ac-AKY-2519 initiation
3. Treatment with a prior targeted radiotherapy, except for patients in Group B, who must have received least 2prior Pluvicto™
4. Prior treatment with a B7-H3 targeted therapy
5. Participants with impaired cardiac function or clinically significant cardiac disease

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.

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

Patient Eligibility Criteria: See the complete list at 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 see the complete list on ClinicalTrials.gov

Description: This study is to evaluate the safety of [64Cu]CM500 and [68Ga]CM500 PET imaging and their whole-body distribution, metabolism, pharmacokinetics, and radiation burden in healthy volunteers and to measure the distribution of [64Cu]CM500 and [68Ga]CM500 PET in patients with different types of cancer.

BAMF Health is only enrolling patients with different types of cancer – bladder, brain, breast, colorectal, esophageal, gastric, head & neck, kidney, liver, lung, ovarian, pancreatic, prostate, or uterine cancers.

The study will last approximately 1 week for each patient and includes a Screening Period, a 2-day Imaging Period, and a Safety Follow-up Period (48 hrs post dose).

Number of patients to be enrolled (study wide): 40 Patients study wide

Patient Eligibility Criteria: Participants may be eligible for this study if they:

• Are age 18 or older
• Have a known solid tumor cancer
• Meet study requirements for bloodwork, kidney function, and overall health status

Participants may not be eligible if they:

• Have certain significant medical conditions or uncontrolled illnesses
• Have certain heart rhythm abnormalities or other safety concerns identified during screening
• Participated in another clinical study or therapeutic clinical trial in the past 30 days

Protocol Title: Total-Body [¹⁸F]NaF PET-CT for Characterization of Vascular Microcalcification in Metabolic Disorders

Sponsor: BAMF Health

Description: CVDetection is a single-center, exploratory research imaging study evaluating [¹⁸F]NaF total-body PET-CT in adults with and without systemic metabolic disorders. The study is designed to characterize how [¹⁸F]NaF is distributed in the body and how vascular uptake patterns compare between adults with metabolic conditions and metabolically healthy adults without known cardiovascular disease

Participants will complete a screening visit, one research imaging visit, and a follow-up safety phone call. Study procedures include a cardiometabolic health evaluation, blood testing, a single [¹⁸F]NaF PET-CT scan, and an ECG-gated CT scan for coronary artery calcium scoring.

This study is for research purposes only. It is not intended to diagnose cardiovascular disease, guide treatment, evaluate screening performance, or provide individual clinical risk prediction.

Number of patients to be enrolled (study wide): Up to 30 adult participants.

Patient Eligibility Criteria: Participants may be eligible if they are adults 20–79 years old without known or pre-existing cardiovascular disease and fit one of the following groups:

Group 1: Metabolic Condition Group:

Adults with systemic metabolic disorder features, such as type 2 diabetes, prediabetes, metabolic syndrome, MASLD/NAFLD, obesity, hypertension, dyslipidemia, or other cardiometabolic risk factors.

Group 2: Control Group:

Adults without known cardiovascular disease and without known systemic metabolic disorders.

Key exclusion considerations include:

• Known cardiovascular disease, such as prior heart attack, coronary artery disease, stroke/TIA, peripheral artery disease, heart failure, coronary stent, bypass surgery, or other revascularization procedure
• Pregnancy or inability to complete pregnancy testing when applicable
• Medical conditions that may affect participant safety or study imaging interpretation
• Inability to complete study visits or follow study procedures

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.

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

Patient Eligibility Criteria: view patient eligibility criteria

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

Protocol Title: A Dose Escalation and Dose Optimization Phase 1a/1b Study to Evaluate Safety, Tolerability and Dosimetry of Radioligand Therapy With LY4337713 in Adults With FAP-Positive Solid Tumors (FiREBOLT)

Sponsor: Eli Lilly and Company

Description: This is a study of LY4337713 in participants with certain types of cancer that is advanced or has spread. Participants must have cancer with high levels of a protein called fibroblast activation protein (FAP). The purpose of this study is to evaluate safety, side effects, and efficacy of LY4337713. In addition, this study will evaluate how much LY4337713 gets into the bloodstream, how it is broken down, and how long it takes the body to get rid of it. For each participant, the study will last about 5 years. The trial will enroll patients with ovarian, breast, pancreatic, colorectal, esophageal, stomach, and cholangiocarcinoma cancers.

Number of patients to be enrolled (study wide): 241

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

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

Protocol Title: Phase I study of [68Ga]Ga-DFC413, and [68Ga]Ga-NNS309 in patients with solid tumors

Sponsor: Novartis Pharma AG

Description: This study is to characterize imaging properties and characteristics of 68Ga-DFC413 (tumor uptake, kinetics, and biodistribution) and determine the optimal post-injection timepoint for 68Ga-DFC413 imaging.

The study will last approximately 3 weeks for each patient and includes a Screening Period (up to 14 days), a 1-day Imaging Period, and a Safety Follow-up Period (4 days post dose).

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

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

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 administered 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.

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.

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.

Number of patients to be enrolled (study-wide): 421 Patients.

Patient Eligibility Criteria: Please 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)

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

Patient Eligibility Criteria: 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 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

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

Patient Eligibility Criteria: see the complete list at ClinicalTrials.Gov

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

Phase 2/3 [68Ga]-LNTH-2401 PET/CT Dose Optimization and Diagnostic Performance in Prostate Cancer (SPARROW [Staging Prostate Cancer with Advanced RM2 Radiotracer Oncologic Workup]).

Sponsor: Lantheus Medical Imaging

Description: This is an open-label, nonrandomized, multicenter Phase 2/3 study conducted in two sequential parts: Phase 2 Dose Optimization followed by Phase 3 Diagnostic Performance.

BAMF Health is currently only enrolling patients into Phase 2.

Phase 2 prospectively evaluates administered activity and imaging time window and characterizes biodistribution, dosimetry, image quality, and safety of [68Ga]-LNTH-2401 (PET/CT imaging agent) to select imaging parameters for Phase 3.

Phase 2 of the study will last approximately 36 days for each patient and includes a Screening Period (up to 28 days), a 1-day Imaging Period, and a Safety Follow-up Period (5 days post dose).

Number of patients to be enrolled (study wide): for phase 2, up to 12 study wide

Patient Eligibility Criteria: Participants may be eligible for this study if they:

• Are age 18 or older
• Have newly diagnosed high risk prostate cancer and planned treatment with radical prostatectomy or biochemically recurrent prostate cancer
• Meet study requirements for bloodwork, kidney function, and overall health status

Participants may not be eligible if they:

• Have certain significant medical conditions or uncontrolled illnesses
• Have certain heart rhythm abnormalities or other safety concerns identified during screening
• Participate in another clinical study at the time of screening for this study

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: see the complete list on ClinicalTrials.gov

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