161Tb-NYM032 for Metastatic Castration-Resistant Prostate Cancer
30 mCi NYMO32
+ 50 mCi NYMO32
+ 80 mCi NYMO32
Neoplasms
Treatment Study
Summary
Study start date: February 11, 2025
Actual date on which the first participant was enrolled.This study focuses on evaluating a new treatment called 161Tb-NYM032 for patients with metastatic castration-resistant prostate cancer. This type of cancer continues to grow and spread despite treatments that lower testosterone levels. The study aims to assess if this new radiopharmaceutical, which targets cancer cells, is safe and well-tolerated by patients. Researchers are hopeful that this trial can provide new insights and potentially improve treatment options for individuals battling this aggressive form of prostate cancer. Participants in the study will receive 161Tb-NYM032, which is a specially designed radioactive drug, through a medical process. The study will closely monitor the patients to understand how their bodies handle the drug and to check for any side effects. The trial will also look at how effective the drug is in controlling or reducing the cancer, though the main focus is on safety and tolerability at this initial stage. As this is an early phase trial, learning about any risks and benefits is crucial for future research and development.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.15 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
\*\*1. Inclusion Criteria\*\* 1. The participant voluntarily signs the informed consent form and is able to complete the trial according to the protocol requirements. 2. Male, aged 18 years or older. 3. Diagnosed with metastatic castration-resistant prostate cancer (mCRPC) as per PCWG3 criteria. 4. Positive results on 68Ga-NYM032 positron emission tomography (PET)/computed tomography (CT) scan. 5. Must have received at least one NAAD treatment (e.g., enzalutamide and/or abiraterone) or at least one taxane-based treatment regimen, or be intolerant to or refuse taxane therapy for metastatic castration-resistant prostate cancer. 6. ECOG performance status of 0-2. 7. Expected survival of ≥6 months. 8. Laboratory parameters must meet the following: 1. ALT and AST must not exceed 3 times the upper limit of normal (ULN); BUN and Cr must not exceed 1.5 times the ULN. 2. Blood counts: WBC ≥3.5×10\^9/L, PLT ≥100×10\^9/L, Hb ≥90 g/L.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives