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A Study of BB-1701 in Previously Treated Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive or HER2-low Unresectable or Metastatic Breast Cancer

Status
Active
Cancer Type
Breast Cancer
Unknown Primary
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT06188559
Protocol IDs
BB-1701-G000-205 (primary)
NCI-2024-00539
2023-506866-30
Study Sponsor
Eisai Inc

Summary

The primary purpose of the Dose Optimization (Part 1) of this study is to assess the
safety and tolerability of BB-1701 and to determine the recommended dose (RD) of BB-1701
for Dose Expansion (Part 2). The primary purpose of Dose Expansion (Part 2) is to assess
the antitumor activity of BB-1701 at RD in the selected population(s) of breast cancer
(BC).

Eligibility

  1. Male or female, aged >=18 years at the time of informed consent.
  2. Metastatic or unresectable BC that is histologically confirmed to be either HER2-positive (defined as an immunohistochemistry [IHC] status of 3+, or a positive in situ hybridization [ISH] test [fluorescence, chromogenic, or silver-enhanced ISH] if IHC status is 2+) or HER2-low (defined as an IHC status of 1+, or 2+ and negative ISH) per the American Society of Clinical Oncology/College of American Pathology guidelines as documented prior to trastuzumab deruxtecan (T-DXd) treatment.
  3. Must have previously received T-DXd.
  4. Sufficient tumor tissue is required for HER2 status testing at a central laboratory.
  5. Measurable disease per RECIST 1.1 as assessed by the investigator. Participants with bone only disease may be eligible if there is a measurable soft tissue component associated with the bone lesion.
  6. Must have previously received at least 1 but no more than 3 prior chemotherapy-based regimes in the unresectable or metastatic setting. If recurrence occurred during or within 6 months of (neo) adjuvant chemotherapy, this would count as 1 line of chemotherapy.
  7. If HR-positive HER2-low BC, must have previously received endocrine therapy and is not expected to further benefit from it.
  8. ECOG PS 0 or 1.
  9. Life expectancy of at least 3 months.
  10. Adequate organ function and laboratory parameters.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.