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

Part of paid clinical trials in La Jolla, California.

Sponsor
Regor Pharmaceuticals Inc.
Study ID
NCT05304962
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RGT-419B — DRUG
    oral capsules
  • RGT-419B in combination with hormonal therapy — DRUG
    RGT-419B in combination with hormonal therapy (Selective Estrogen Receptor Degrader, Selective Estrogen Receptor Modulator, or Aromatase Inhibitor)

Study Details

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.

Key Dates

Start date
Mar 4, 2022
Status verified
Mar 2026
Primary completion
Sep 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
64 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    RGT-419B given alone as monotherapy
  • Experimental: Arm B
    RGT-419B in combination with Hormonal Therapy

Primary Outcome Measure

Safety & Tolerability - Number of subjects with Dose-Limiting Toxicities (DLTs) at each cohort dose level in singlet and doublet therapy [ Time Frame: 4 weeks (1 cycle) ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
University of California, San DiegoLa JollaCalifornia92037
Sauntee Braddock
[email protected]
858-534-8248
Rebecca Shatsky, MD (PRINCIPAL_INVESTIGATOR)
University California, Los AngelesLos AngelesCalifornia90404
Monica Rocha
[email protected]
310-998-4747
Saeed Sadeghi, MD (PRINCIPAL_INVESTIGATOR)
Hem-Onc Associates of the Treasure CoastPort Saint LucieFlorida34952-
Moffitt Cancer CenterTampaFlorida33612
Taylor L Whann
[email protected]
813-745-0824
Heather Han, MD (PRINCIPAL_INVESTIGATOR)
Emory UniversityAtlantaGeorgia30322
Ashley Trumbull, MS
[email protected]
404-778-3969
Kathleen Coleman
[email protected]
404.251.1278
Kevin Kalinsky, MD, MS (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02142
Amber Newton
[email protected]
617-726-1634
Abigail Fessele
[email protected]
(P): 617-724-8305
Seth Wander, MD (PRINCIPAL_INVESTIGATOR)
Washington University School of MedicineSt LouisMissouri63110
Sammie Ruzicka, LMSW
[email protected]
314-747-5209
Tracy Summa, CCRP
[email protected]
314.362.0263
Katherine Clifton, MD (PRINCIPAL_INVESTIGATOR)
New York Cancer and Blood SpecialistsPort Jefferson StationNew York11776
Laura Parisi, LPN
[email protected]
631-675-5146
Lauren Gianelli-Bilka, LPN
[email protected]
631-675-5256
Richard Zuniga, MD (PRINCIPAL_INVESTIGATOR)

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University of California, San Diego· La Jolla, CAUniversity California, Los Angeles· Los Angeles, CAHem-Onc Associates of the Treasure Coast· Port Saint Lucie, FLMoffitt Cancer Center· Tampa, FLEmory University· Atlanta, GAMassachusetts General Hospital· Boston, MA

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