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NCT05304962 | RECRUITING | Breast Cancer

FIH Study of RGT-419B Alone and With Endocrine Therapy in HR-Positive, HER2-Negative Advanced/Metastatic Breast Cancer
Sponsor:

Regor Pharmaceuticals Inc.

Brief Summary:

This is a phase I, First-in-Human (FIH), open-label study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and preliminary efficacy of RGT-419B administered orally as monotherapy OR in combination with Hormonal Therapy in subjects with HR+, HER2- locally advanced and unresectable (Stage III) or metastatic (Stage IV) breast cancer whose disease has progressed during prior therapy with an approved CDK4/6i plus hormonal therapy.

Condition or disease

Breast Cancer

Intervention/treatment

RGT-419B

RGT-419B in combination with hormonal therapy

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 64 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : First-in-Human, Escalating Oral Dose Study of RGT-419B Given Alone and With Endocrine Therapy in Subjects With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Advanced/Metastatic Breast Cancer
Actual Study Start Date : 2022-03-04
Estimated Primary Completion Date : 2025-12-30
Estimated Study Completion Date : 2026-09-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Male or female \>/= 18 years old
  • 2. ECOG Performance Status 0 to 1
  • 3. Subjects must have histologically or cytologically confirmed diagnosis of ER+, HER2- ABC consistent with ASCO CAP guidelines that is locally advanced and unresectable (Stage III) or metastatic (Stage IV) BC.
  • 4. Measurable AND evaluable lesions at baseline per RECIST v1.1.
  • 5. Eligible subjects must meet all of the following criteria
    • * Progression after receiving 1 line of prior cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) therapy combined with HT in the MBC setting (up to 1 additional line of CDK4/6i is permitted in the post-surgical adjuvant setting);
    • * Subjects must have received therapy for ≥3 months in the MBC setting, or for ≥6 months in the adjuvant setting, prior to progression
    • * Progression after ≤3 lines of prior HT therapy (regardless of whether it is HT alone or in combination with other therapies)
    • * Prior HT combination agents, including SERD, SERM or AI, must have received formal approval by regulatory agency.
    • * ≤ 1 prior line of chemotherapy in the metastatic setting
    • 6. Adequate organ function
    • 7. Ability to understand and the willingness to sign a written informed consent document
    Exclusion Criteria
    • 1. Presence of visceral metastases with severe organ dysfunction as evidence by signs and symptoms, laboratory studies, lymphangitic spread and/or rapid progression of disease
    • 2. Pregnant or planning to become pregnant
    • 3. Prior irradiation to \>25% of the bone marrow and/or inadequate bone marrow function or evidence of clinically significant end-organ damage
    • 4. Major surgery, chemotherapy, targeted therapy, experimental agents, or radiation within 14-28 days prior to Cycle 1, Day 1
    • 5. Active, serious medical condition that is not well controlled with locally approved medications allowed by the protocol
    • 6. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the drugs used in the study
FIH Study of RGT-419B Alone and With Endocrine Therapy in HR-Positive, HER2-Negative Advanced/Metastatic Breast Cancer

Location Details

NCT05304962

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Locations

RECRUITING

United States, California

University of California, San Diego

THE JOLLA, California, United States, 92037

RECRUITING

United States, California

University California, Los Angeles

Los Angeles, California, United States, 90404

ACTIVE NOT RECRUITING

United States, Florida

Hem-Onc Associates of the Treasure Coast

Port Saint Lucie, Florida, United States, 34952

RECRUITING

United States, Florida

Moffitt Cancer Center

Tampa, Florida, United States, 33612

RECRUITING

United States, Georgia

Emory University

Atlanta, Georgia, United States, 30322

RECRUITING

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02142

RECRUITING

United States, Missouri

Washington University School of Medicine

Saint Louis, Missouri, United States, 63110

RECRUITING

United States, New York

New York Cancer and Blood Specialists

Port Jefferson Station, New York, United States, 11776