Übersicht

Eignung

Details zum Design

Arme & Interventionen

Ergebnismessungen

Studienzentren

Quelle: NCT05304962

Rekrutiert

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

Interventionsstudie

Phase 1

Washington University School of Medicine

Sponsor: Regor Pharmaceuticals

Zuletzt aktualisiert: 20. April 2025
Hinweis - Die Informationen stammen aus öffentlichen Registern und spiegeln möglicherweise nicht die Echtzeitänderungen am lokalen Studienzentrum wider.

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.

Behandlungskategorie

Andere Medikamente

Erforderliche Mutationen

HR, ER

Studie gestartet

4. März 2022

Zuletzt vom Sponsor aktualisiert

20. April 2025

Voraussichtlicher Abschluss

30. Dezember 2025

Studienkontakt

Name:Joanna Dojillo, MSc

E-Mail:joanna.dojillo@regor.com

Telefon:617-315-9070

Name:Regor Pharmaceuticals Central Office

E-Mail:rgt-419b_01-101@regor.com

Telefon:617-315-9070

Eignung

Einschlusskriterien

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

Ausschlusskriterien

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

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Design-Details

ZuteilungNon-Randomized

InterventionsmodellSequential Assignment

MaskierungNone (Open Label)

Anzahl der Teilnehmer64

Arme & Interventionen

Arme

Interventionen

Typ: Experimental

Beschreibung: RGT-419B given alone as monotherapy

Interventionen:

RGT-419B
RGT-419B in combination with hormonal therapy

Ergebnismessungen

Primäre Ergebnismessungen

Safety & Tolerability - Number of subjects with Dose-Limiting Toxicities (DLTs) at each cohort dose level in singlet and doublet therapy4 weeks (1 cycle)

Number of subjects who have a confirmed DLT at each cohort dose level in singlet and doublet study arms during the first 28-day cycle of RGT-419B treatment.

Sekundäre Ergebnismessungen

Safety & Tolerability - Incidence, Severity, and Causality of all Treatment Emergent Adverse Events (TEAEs)through study completion, an average of 1 year

Incidence, severity, and causality of all TEAEs will be assessed for all patient participating from Day 1 dosing through end of study.

Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Cmaxthrough study completion, an average of 1 year