A Phase 1b, Open-Label Parallel Study Evaluating CLR 125 in Patients With Relapsed or Refractory Triple Negative Breast Cancer
Cellectar Biosciences, Inc.
Summary
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.
Description
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 patien…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Unequivocal TNBC histology \[ER and PR less than 10% each and HER-2 negative\]. * Patients that have progressed after at least one prior standard therapeutic regimen given alone or in combination (including, but not limited, to: chemotherapy, immunotherapy, sacituzumab govitecan-hziy, trastuzumab deruxtecan). * Patients who have received neo-adjuvant or adjuvant therapy must be at least one year from that treatment regimen. * Patient is ≥ 18 years of age. * ECOG performance status of 0 to 2. * Life expectancy ≥ 6 months. * Patient must meet the following laboratory cr…
Interventions
- DrugIopofosine I 131
Investigational radiopharmaceutical product intended for IV administration.
- DrugCLR 125
Investigational radiopharmaceutical product intended for IV administration.
Locations (3)
- Mayo Clinic FloridaJacksonville, Florida
- United TheranosticsGlen Burnie, Maryland
- United TheranosticsPrinceton, New Jersey