FIH Study of RGT-419B Alone and With Endocrine Therapy in HR-Positive, HER2-Negative Advanced/Metastatic Breast Cancer
NCT ID: NCT05304962
Last Updated: 2025-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
64 participants
INTERVENTIONAL
2022-03-04
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Arm A
RGT-419B given alone as monotherapy
RGT-419B
oral capsules
Arm B
RGT-419B in combination with Hormonal Therapy
RGT-419B in combination with hormonal therapy
RGT-419B in combination with hormonal therapy (Selective Estrogen Receptor Degrader, Selective Estrogen Receptor Modulator, or Aromatase Inhibitor)
Interventions
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RGT-419B
oral capsules
RGT-419B in combination with hormonal therapy
RGT-419B in combination with hormonal therapy (Selective Estrogen Receptor Degrader, Selective Estrogen Receptor Modulator, or Aromatase Inhibitor)
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Regor Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Locations
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University of California, San Diego
La Jolla, California, United States
University California, Los Angeles
Los Angeles, California, United States
Hem-Onc Associates of the Treasure Coast
Port Saint Lucie, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
New York Cancer and Blood Specialists
Port Jefferson Station, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RGT-419B_01-101
Identifier Type: -
Identifier Source: org_study_id
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