The goal of this clinical trial is to evaluate the safety and efficacy of 3 different dose levels of CLR 125 in patients with advanced triple negative breast cancer. The main questions the study aims to answer are: * What dose and regimen should be used in future trials of CLR 125 in patients with advanced triple negative breast cancer. * What side effects do participants have when taking CLR 125. Participants will: * Have CLR 125 administered via infusion 4 times each cycle; repeated every 8 weeks. * Visit the clinic once every 3 weeks for checkups and testing. * Report any side effects or new medications. Some participants may also receive one dose of CLR 131 to evaluate the amount of radiation delivered to various organs and to the tumor. These participants will: * Have 4 scans completed over 2 weeks * Have blood drawn 6 times over 2 weeks.
This study is designed to determine the recommended dose and regimen for future trials and to evaluate the safety and tolerability of CLR 125 at the selected doses in patients with advanced triple negative breast cancer. It will also determine the antitumor activity (treatment response by RECIST v1.1) through assessment of overall response rate, progression free survival, overall survival, duration of response and duration of clinical benefit of CLR 125 in patients with advanced triple negative breast cancer. Total body, organ, and tumor dosimetry will be assessed in a select number of patients prior to CLR 125 dosing. At the conclusion of the study, total body, organ, and tumor dosimetry will be calculated for the intended patient population, to inform future studies. Up to 60 evaluable patients will be enrolled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Investigational radiopharmaceutical product intended for IV administration.
Investigational radiopharmaceutical product intended for IV administration.
Mayo Clinic Florida
Jacksonville, Florida, United States
RECRUITINGUnited Theranostics
Glen Burnie, Maryland, United States
RECRUITINGMayo Clinic Rochester
Rochester, Minnesota, United States
RECRUITINGUnited Theranostics
Princeton, New Jersey, United States
RECRUITINGDose Determination for CLR 125
Identify the recommended Phase 2 dose and regimen of CLR 125 in advanced TNBC patients
Time frame: 57 days after initiation of last cycle (each cycle is 57 days)
Number of adverse events related to study treatment (CLR 125)
Adverse Events are graded per NCI CTCAE v5.0
Time frame: Assessed throughout the study through 1 year following completion of treatment.
Efficacy Evaluation for Overall Response Rate
To determine the overall response (ORR) rate as assessed by RECIST v1.1.
Time frame: 57 days after initiation of last cycle (each cycle is 57 days)
Efficacy Evaluation for Progression Free Survival
To determine the therapeutic activity defined as Progression Free Survival (PFS) using Kaplan Meier estimator.
Time frame: Assessed throughout the study through 1 year following completion of treatment
Efficacy Evaluation for Overall Survival
To determine the therapeutic activity defined as Overall Survival (OS) using Kaplan Meier estimator.
Time frame: Assessed throughout the study through 1 year following completion of treatment
Evaluation for Duration of Response
To determine the therapeutic activity defined as Duration of Response (DOR) using Kaplan Meier estimator.
Time frame: Assessed throughout the study through 1 year following completion of treatment
Efficacy Evaluation for Duration of Clinical Benefit
To determine the therapeutic activity defined as Duration of Clinical Benefit (DOCB) using Kaplan Meier estimator.
Time frame: Assessed throughout the study through 1 year following completion of treatment.
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