Clinical Trial - NCT03250676

Trial of H3B-6545, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer

Recruiting

Sponsor: H3 Biomedicine Inc.

Collaborators: Eisai Inc.

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT03250676

Protocol Info

Short Description: Trial of H3B-6545, a Covalent Antagonist of Estrogen Receptor Alpha, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer
Long Description: A Phase I-II Multicenter, Open Label Trial of H3B-6545, A Covalent Antagonist of Estrogen Receptor Alpha, in Women with Locally Advanced or Metastatic Estrogen Receptor-Positive, HER2 Negative Breast Cancer
MGH Status: Open
Sponsor: H3 Biomedicine Inc.
Disease Program: Breast

Next Steps


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Purpose

The purpose of phase 1 is to determine safety, tolerability and pharmacokinetics (PK) of H3B-6545 in women with locally advanced or metastatic estrogen receptor-positive, human epidermal growth factor 2 (HER2)-negative breast cancer. The purpose of phase 2 is to estimate the efficacy of H3B-6545 in terms of response rate, duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS).
Condition Title Intervention Phase
Breast Neoplasms Breast Cancer Estrogen-receptor Positive Breast Cancer Cancer, Breast Breast Cancer Female Breast Adenocarcinoma Estrogen Receptor Positive Tumor ER Positive H3B-6545 Phase 1/Phase 2
Study Type Interventional
Official Title A Phase I-II Multicenter, Open Label Trial of H3B-6545, a Covalent Antagonist of Estrogen Receptor Alpha, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer

Primary Outcome Measures

Number of Participants with Dose-limiting Toxicities (DLTs) [Time Frame: Phase 1 Cycle 1 (28 days)] [Designated as safety issue: ]

Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Time Frame: Phase 1 and 2 continuously throughout the study until 28 days after treatment discontinuation (up to 36 months)] [Designated as safety issue: ]


Secondary Outcome Measures

Area under the Plasma Concentration-time Curve from Time 0 Through the Last Measurable Point (AUC0-t) of H3B-6545 [Time Frame: Phase 1, Cycle 1 (28-day cycles): Days 1 and 15 pre-dose and at multiple time points (up to 24 hours) post-dose; or Phase 2 Cycle 1 (28-day cycles): Days 15 or 22 pre-dose and at multiple time points (up to 24 hours) post-dose] [Designated as safety issue: ]

Mean Maximum Observed Plasma Concentration (Cmax) of H3B-6545 [Time Frame: Phase 1, Cycle 1 (28-day cycles): Days 1 and 15 (pre-dose and at multiple time points (up to 24 hours) post-dose; or Phase 2 Cycle 1 (28-day cycles): Days 15 or 22 pre-dose and at multiple time points (up to 24 hours) post-dose] [Designated as safety issue: ]

Time of Maximum Observed Plasma Concentration (tmax) of H3B-6545 [Time Frame: Phase 1, Cycle 1 (28-day cycles): Days 1 and 15 pre-dose and at multiple time points (up to 24 hours) post-dose; or Phase 2 Cycle 1 (28-day cycles): Days 15 or 22 pre-dose and at multiple time points (up to 24 hours) post-dose] [Designated as safety issue: ]

Duration of Response (DoR) [Time Frame: Phase 1 and 2 up to approximately 36 months] [Designated as safety issue: ]

Disease Control Rate (DCR) [Time Frame: Phase 1 and 2 up to approximately 36 months] [Designated as safety issue: ]

Progression-free survival (PFS) [Time Frame: Phase 1 and 2 up to approximately 36 months] [Designated as safety issue: ]

Overall Survival (OS) [Time Frame: Phase 1 and 2 up to approximately 36 months] [Designated as safety issue: ]

Estimated Enrollment: 110
Study Start Date: August 2017
Estimated Study Completion Date: May 2020
Estimated Primary Completion Date: November 2019
Arms Assigned Interventions

Experimental:H3B-6545 Arm 1: Dose escalation

Drug:H3B-6545
Oral capsules by mouth once daily

Experimental:H3B-6545 Arm 2: Phase 2

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: Female

Accepts Healthly Volunteers: No

Inclusion Criteria:

1. Pre- or post-menopausal women.

2. ER-positive, HER2-negative breast cancer that is advanced or metastatic.

3. Progressed on prior therapy. Multiple prior lines of therapy allowed in Phase 1 and 2.

4. Must be willing to undergo a biopsy prior to treatment and on Cycle 2 Day 1.

5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.

6. Adequate bone marrow and organ function.

Exclusion Criteria:

1. Participant with bone-only disease (Phase I only). Note: Phase II subjects may have predominantly lytic bone only disease.

2. Participant with inflammatory breast cancer.

3. Participant has received more than one prior chemotherapy regimen for metastatic disease (Phase II only).

4. Females of childbearing potential who are unable or unwilling to follow adequate contraceptive measures.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT03250676

Locations

  • United States, California
    • University of California Los Angeles Los Angeles, California, United States, 90404
    • University of California San Francisco San Francisco, California, United States, 94158
  • United States, Florida
    • Holy Cross Hospital Inc Fort Lauderdale, Florida, United States, 33308
    • Florida Cancer Specialists South Fort Myers, Florida, United States, 33901
    • Florida Cancer Specialists North Saint Petersburg, Florida, United States, 33705
    • Florida Cancer Specialists and Research Institute Sarasota, Florida, United States, 34232
  • United States, Illinois
    • Carle Cancer Center Urbana, Illinois, United States, 61801
  • United States, Maryland
    • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Baltimore, Maryland, United States, 21287
  • United States, Massachusetts
    • Massachusetts General Hospital Boston, Massachusetts, United States, 02114
  • United States, Michigan
    • University of Michigan Ann Arbor, Michigan, United States, 48109
  • United States, Missouri
    • Saint Luke's Cancer Institute Kansas City, Missouri, United States, 64111
    • Research Medical Center Kansas City, Missouri, United States, 64132
  • United States, North Carolina
    • University of North Carolina Chapel Hill, North Carolina, United States, 27599
  • United States, Tennessee
    • Tennessee Oncology Nashville, Tennessee, United States, 37203
  • United States, Texas
    • UT Southwestern Medical Center Dallas, Texas, United States, 75390
  • United States, Utah
    • Huntsman Cancer Institute at The University of Utah Salt Lake City, Utah, United States, 84112
  • United Kingdom,
    • Velindre Cancer Centre Cardiff, , United Kingdom, CF14 2TL
    • Barts Health NHS Trust London, , United Kingdom, EC1A 7BE
    • Christie Hospital Manchester, , United Kingdom, M20 4BX
    • The Royal Marsden NHS Foundation Trust Sutton, , United Kingdom, SM2 5PT

Sponsors and Collaborators

H3 Biomedicine Inc.

Eisai Inc.

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT03250676
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:

Keywords provided by Eisai Inc.:

HER2

estrogen receptor

H3B-6545

breast cancer

Endocrine Therapy

Additional relevant MeSH terms:

Breast Neoplasms

Adenocarcinoma

Estrogens

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on August 15, 2019