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Title: A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors

Sponsor: Aktis Oncology, Inc.

Description: This study consists of two parts (Part 1 and 2).

Part 1 is the dose escalation portion of the study, which will investigate ascending doses of [225Ac]Ac-AKY-1189 (up to 6 cycles) in patients with locally advanced or metastatic solid tumors. The aim of Part 1 is to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and the recommended Phase 2 dose.

Part 2 will be the dose expansion portion of the study and will enroll locally advanced or metastatic solid tumor patients who are identified as Nectin-4 positive by [64Cu] Cu-AKY-1189. Part 2 aims to further assess the efficacy of [225Ac]Ac-AKY-1189 at the RP2D in 3 different cohorts of patients.

ClinicalTrials.gov: NCT07020117

Title: Phase 1 Study of CLR 125 in Triple Negative Breast Cancer

Sponsor: Cellectar Biosciences, Inc.

Description: This is a Phase 1b, randomized, open-label, multi-center study assessing the safety and efficacy of CLR 125 in patients with advanced TNBC. Three dose levels will be assessed in parallel, with enrollment of patients in a 1:1:1 manner. Each arm will have a minimum of 15 evaluable patients. Depending on arm assignments, patients will receive between two and four cycles. A Cycle is defined as an 8-week period (57 days), with CLR 125 administrated on Days 1, 2, 8, and 9 of each Cycle. An expansion arm may be evaluated in a minimum of at least 15 patients following evaluation of the three dose levels by the data monitoring committee (DMC).

ClinicalTrials.gov: NCT07311993

Title: Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer

Sponsor: Curium US LLC

Description: This is a prospective, open-label Phase 3 study to evaluate copper Cu 64 PSMA I&T injection for PET/CT imaging in patients with newly diagnosed unfavorable intermediate high-risk, high-risk or very high-risk prostate cancer.

ClinicalTrials.gov: NCT06235151

Title: A Study of LY4337713 in Participants With FAP-Positive Solid Tumors

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.

ClinicalTrials.gov: NCT07213791

Title: A Phase 0 study of [111In]In-MC-760 in Patients with Solid Tumors that Commonly Express B7-H3.

Sponsor: Mariana Oncology

Description: A Phase 0, Open-label First-in-Human Study to Evaluate the Biodistribution, Safety,
Tolerability, Pharmacokinetics, and Radiation Dosimetry of [111In]In-MC-760 in Adult
Patients with Solid Tumors that Commonly Express B7-H3

ClinicalTrials.gov: N/A - it is Phase 0

Title: Study of [212Pb]Pb-DOTAM-MAM279 ([212Pb]Pb-MP0712) in Patients With Small Cell Lung Cancer and Other DLL3 Expressing Solid Tumors

Sponsor: Molecular Partners AG

Description: This is a phase I/IIa, open-label, multi-center study to evaluate the safety, tolerability, dosimetry, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of [212Pb]Pb-MP0712 in patients with SCLC and other advanced DLL3-expressing solid tumors. The study consists of a dose escalation part, followed by a dose expansion part. Once the recommended radioactive dose(s) [212Pb]Pb-MP0712 for further clinical evaluation are determined, the dose expansion part will further characterize the safety, tolerability, and preliminary anti-tumor activity of [212Pb]Pb-MP0712. The study will enable evaluation of the safety, dosimetry, PK, and imaging properties of [203Pb]Pb-MP0712.

ClinicalTrials.gov: NCT07278479

Title: Safety and Tolerability of ²¹²Pb-DOTAM-GRPR1 in Adult Subjects With Recurrent or Metastatic GRPR-expressing Tumors

Sponsor: Orano Med Theranostics, SAS

Description: A Phase 1 Open-Label, First-in-human, Dose Escalation and Expansion Study to Determine the Safety, Tolerability, Dosimetry, Pharmacokinetics, and Preliminary Efficacy of 212Pb-DOTAM-GRPR1 in Adult Participants with Recurrent or Metastatic GRPR-expressing Tumors

ClinicalTrials.gov: NCT05283330

Title: A Phase 1 Study of 68Ga-R11228 and 177Lu-R11228 in Breast Cancer

Sponsor: Radionetics Oncology

Description: Part A is being conducted to test 68Ga-R11228, a new investigational product (IP) that has been designed to detect cancer lesions in the body and make them visible on a Positron Emission Tomography (PET) scan. Three dose levels of 68Ga-R11228 will be evaluated, with each patient receiving a single dose. Part B is being conducted to test 68Ga-R11228 and additionally 177Lu-R11228, which has been designed to treat patients who have cancer lesions with positive uptake on PET scan using 68Ga-R11228. Patients who qualify for 177Lu-R11228 treatment will receive up to 6 doses over approximately 36 weeks. Multiple 177Lu-R11228 dose levels will be evaluated in Part B.

ClinicalTrials.gov: NCT07121244

Title: Phase 1 Imaging Study of 68Ga-R12961 in Advanced Solid Tumors

Sponsor: Radionetics Oncology

Description: This is an open-label, first-in-human, Phase 1 study of 68Ga-R12961 designed to characterize its safety, biodistribution, tumor detection capability, radiation dosimetry, and PK in participants with advanced solid tumors including head and neck squamous cell carcinoma, gastric cancer, colorectal cancer, and any other metastatic solid tumor, for example NSCLC, breast cancer, pancreatic cancer, and melanoma.

ClinicalTrials.gov: Not yet available

Title: Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy

Sponsor: RayzeBio, Inc.

Description: This study aims to determine the safety, pharmacokinetics (PK) and recommended Phase 3 dose (RP3D) of RYZ101 in Part 1, and the safety, efficacy, and PK of RYZ101 compared with investigator-selected standard of care (SoC) therapy in Part 2 in subjects with inoperable, advanced, well-differentiated, somatostatin receptor expressing (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have progressed following treatment with Lutetium 177-labelled somatostatin analogue (177Lu-SSA) therapy, such as 177Lu-DOTATATE or 177Lu-DOTATOC (177Lu-DOTATATE/TOC), or 177Lu-high affinity [HA]-DOTATATE.

ClinicalTrials.gov: NCT05477576

Title: The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT Global)

Sponsor: Telix Pharmaceuticals (Innovations) Pty Limited

Description: The purpose of this study is to evaluate the efficacy and safety of 177Lu-TLX591 in patients with metastatic castration-resistant prostate cancer who have progressed following treatment with Androgen Receptor Pathway Inhibitor Treatment

ClinicalTrials.gov: NCT06520345

Title: Phase 1a/b FIH-trial with [225Ac]Ac-SKL35500, an alpha emitting radiopharmaceutical targeting NTSR1 (neurotensin receptor 1) and [111In]In-SKL35500 (imaging agent), in adult patients with NTSR1-expressing advanced, metastatic and/or recurrent solid tumors.

Sponsor: SK Life Science

Description: This study is a Phase 1, multicenter, open-label clinical study designed to investigate the safety,
tolerability, dosimetry, biodistribution, and pharmacokinetics (PK) of SKL35501 and SKL35502,
as well as the pharmacodynamics (PmD) and preliminary anti-tumor activity of SKL35501 in adult
patients with selected neurotensin receptor 1 (NTSR1)-expressing advanced, metastatic, and/or
recurrent solid tumors. The study will also generate imaging performance parameters for the
imaging companion SKL35502.

ClinicalTrials.gov: Not yet available