OncoMatch/Clinical Trials/NCT07311993
Phase 1 Study of CLR 125 in Triple Negative Breast Cancer
Is NCT07311993 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Iopofosine I 131 and CLR 125 for breast cancer.
Treatment: Iopofosine I 131 · CLR 125 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression < 10% (< 10%)
ER and PR less than 10% each
Required: PR (PGR) expression < 10% (< 10%)
ER and PR less than 10% each
Required: HER2 (ERBB2) negative (negative)
HER-2 negative
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: standard therapeutic regimen (chemotherapy, immunotherapy, sacituzumab govitecan-hziy, trastuzumab deruxtecan)
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).
Cannot have received: targeted radiotherapy
Prior targeted radiotherapy.
Cannot have received: external beam radiation therapy
Exception: resulting in greater than 20% of total bone marrow receiving greater than 20 Gy
Prior external beam radiation therapy resulting in greater than 20% of total bone marrow receiving greater than 20 Gy.
Lab requirements
Blood counts
Platelets ≥ 75,000/uL; WBC ≥ 3000/uL; ANC ≥ 1500/uL; Hemoglobin ≥ 9 g/dL
Kidney function
Estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2
Liver function
AST and ALT ≤ 2.5 × ULN; Bilirubin < 1.5 × ULN
Patient must meet the following laboratory criteria: Platelets ≥ 75,000/uL [75 x 10^9/L]; WBC ≥ 3000/uL; ANC ≥ 1500/uL; Hemoglobin ≥ 9 g/dL; Estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2; AST and ALT ≤ 2.5 × ULN; Bilirubin < 1.5 × ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic Florida · Jacksonville, Florida
- United Theranostics · Glen Burnie, Maryland
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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