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RYZ101 Radioactive Drug with Immunotherapy for Advanced ER+, HER2- Breast Cancer Expressing SSTRs

Phase 1b/2 Open-label Trial of 225Ac-DOTATATE (RYZ101) Alone and in Combination with Pembrolizumab in Subjects with Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor Receptor 2 (HER2)-negative, Locally Advanced and Unresectable or Metastatic Breast Cancer Expressing Somatostatin Receptors (SSTRs) and Progressed After Antibody-drug Conjugates And/or Chemotherapy (TRACY-1)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of RYZ101, an experimental radioactive drug, with pembrolizumab (Keytruda®) immunotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) estrogen receptor (ER+) or ER low, HER2 negative (HER2-) or HER2 low breast cancer that expresses somatostatin receptors (SSTRs) who have no standard treatment options available. View full eligibility criteria

What's involved?

You will receive the following:

  • 225Ac-DOTATATE (RYZ101)
  • Pembrolizumab (Keytruda®)

What's being studied?

  • Researchers are developing a new class of drugs called radiopharmaceuticals, which deliver radiation therapy directly and specifically to cancer cells.
  • 225Ac-DOTATATE (RYZ101) is an experimental radiopharmaceutical or radioactive drug.
  • Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.
  • Somatostatin receptors (SSTRs) are a type of biomarker your tumor may have. Ask your doctor and/or check your pathology report to know if your cancer expresses somatostatin receptors (SSTRs).
  • Biomarkers are genes, molecules, or other features present in a person, including in a person’s tumor, that tell doctors something about a person’s health condition.
  • In this trial, HER2 low is defined as IHC 1+ or IHC 2+/ISH-.

How can I learn more?

1

RYZ101 Radioactive Drug with Immunotherapy for Advanced ER+, HER2- Breast Cancer Expressing SSTRs

Phase 1b/2 Open-label Trial of 225Ac-DOTATATE (RYZ101) Alone and in Combination with Pembrolizumab in Subjects with Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor Receptor 2 (HER2)-negative, Locally Advanced and Unresectable or Metastatic Breast Cancer Expressing Somatostatin Receptors (SSTRs) and Progressed After Antibody-drug Conjugates And/or Chemotherapy (TRACY-1)
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Nearest Location:
1946 miles
Research Facility
Indianapolis, IN

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06590857

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Phase I-II

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