Phase 1 Study of CLR 125 in Triple Negative Breast Cancer
ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCellectar Biosciences, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Focal radiation (including palliative radiation) to non-target lesions should be completed at least 2 weeks prior to dosing.
For patients receiving CLR 125 after participation in the dosimetry phase, CLR 131 washout is not required prior to dosing with CLR 125.
Prior targeted radiotherapy.
Trial design
Treatments tested in this trial
- Iopofosine I 131
- CLR 125
Treatment groups
60 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov