Phase 1 Study of CLR 125 in Triple Negative Breast Cancer

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Cellectar Biosciences, Inc.
Study ID
NCT07311993
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Iopofosine I 131 — DRUG
    Investigational radiopharmaceutical product intended for IV administration.
  • CLR 125 — DRUG
    Investigational radiopharmaceutical product intended for IV administration.

Study Details

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.

Key Dates

Start date
Dec 5, 2025
Status verified
Dec 2025
Primary completion
Feb 29, 2028
Completion
Jul 31, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Dosimetry Phase
    Iopofosine I 131 (CLR 131) will be administered at 10 mCi on day 1 for approximately 15 patients for imaging purposes.
  • Experimental: Treatment Phase: CLR 125 Arm 1
    CLR 125 administered at 65 mCi/m2 fractionated over four doses (day 1, 2, 8, and 9) in each 8-week cycle; patient will receive up to 4 cycles.
  • Experimental: Treatment Phase: CLR 125 Arm 2
    CLR 125 will be administered at 125 mCi/m2 fractionated over four doses (day 1, 2, 8, and 9) in each 8-week cycle; patient will receive up to 3 cycles.
  • Experimental: Treatment Phase: CLR 125 Arm 3
    CLR 125 will be administered at 190 mCi/m2 fractionated over four doses (day 1, 2, 8, and 9) in each 8-week cycle; patient will receive up to 2 cycles.

Primary Outcome Measure

Dose Determination for CLR 125 [ Time Frame: 57 days after initiation of last cycle (each cycle is 57 days) ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Mayo Clinic FloridaJacksonvilleFlorida32224
Clinical Trials Referral Office
[email protected]
855-776-0015
Pooja Advani, MD (PRINCIPAL_INVESTIGATOR)
United TheranosticsGlen BurnieMaryland21061
Amanda Huggins
[email protected]
667-HOPENOW
Babak Saboury, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Karthik Giridhar, MD (PRINCIPAL_INVESTIGATOR)
United TheranosticsPrincetonNew Jersey08540
Amanda Huggins
[email protected]
667-HOPENOW
Munir Ghesani, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Jacksonville, FL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Mayo Clinic Florida· Jacksonville, FLUnited Theranostics· Glen Burnie, MDMayo Clinic Rochester· Rochester, MNUnited Theranostics· Princeton, NJ

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