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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Iopofosine I 131
DrugInvestigational radiopharmaceutical product intended for IV administration.
CLR 125
DrugInvestigational radiopharmaceutical product intended for IV administration.
Treatment groups
60 Participants
are divided into 5 treatment groupsGroup A: Dosimetry PhaseOther 1 intervention
Group B: Treatment Phase: CLR 125 Arm 1Experimental treatment 1 intervention
Group C: Treatment Phase: CLR 125 Arm 2Experimental treatment 1 intervention
Group D: Treatment Phase: CLR 125 Arm 3Experimental treatment 1 intervention
Group E: Treatment Phase: CLR 125 Arm 4Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose 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)2
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.Secondary outcomes
1
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)2
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 treatment3
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 treatment4
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 treatmentOther outcomes
1
Dosimetry Evaluation for Total Body and Normal Organs
To determine total body and organ radiation dosimetry, together, of iopofosine I 131 (CLR 131) in advanced TNBC patients
Time frame
1 hour post-infusion and concluding 11 days post-initial imaging2
Tumor Dosimetry Evaluation of iopofosine I 131 (CLR 131)
Determine the tumor dosimetry of iopofosine I 131 (CLR 131) in advanced TNBC patients.
Time frame
1 hour post-infusion and concluding 11 days post-initial imagingSponsors and contacts
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Source ClinicalTrials.gov