TheranosticTrials.org

Clinical Trial · NCT07311993

Phase 1 Study of CLR 125 in Triple Negative Breast Cancer

Overview

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.

Sponsor

Cellectar Biosciences

Phase

Phase 1

Contacts

Jarrod Longcor (STUDY_DIRECTOR)

Kate Oliver (CONTACT)

clinical@cellectar.com

608-441-8120

ClinicalTrials.gov

NCT07311993

Drug / Compound

Iopofosine I 131

Isotope(s):
Target(s):
  • Phospholipid Metabolism
Ligand Class: Small Molecules

CLR 125

Isotope(s):
Target(s):
  • Phospholipid Metabolism
Ligand Class: Small Molecules

Eligibility

Inclusion

  • * Unequivocal TNBC histology \[ER and PR less than 10% each and HER-2 negative\].
  • Patients who have received neo-adjuvant or adjuvant therapy must be at least one year from that treatment regimen.
  • 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).
  • ECOG performance status of 0 to 2.
  • Patient is ≥ 18 years of age.

Exclusion

  • * Antitumor systemic therapy or investigational therapy, within three-half-lives of the agent preceding study drug administration. NOTE: Patients participating in non-interventional clinical trials (i.e., non-drug) are allowed to participate in this trial.
  • For patients receiving CLR 125 after participation in the dosimetry phase, CLR 131 washout is not required prior to dosing with CLR 125.
  • Prior external beam radiation therapy resulting in greater than 20% of total bone marrow receiving greater than 20 Gy. For estimation purposes, the following bone marrow percentages can be used:
  • Focal radiation (including palliative radiation) to non-target lesions should be completed at least 2 weeks prior to dosing.
  • Prior targeted radiotherapy.