RECRUITING

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

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Conditions

Breast Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2022-03-04
Study Completion:2026-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05304962

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female \>/= 18 years old
  2. 2. ECOG Performance Status 0 to 1
  3. 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. 4. Measurable AND evaluable lesions at baseline per RECIST v1.1.
  5. 5. Eligible subjects must meet all of the following criteria:
  6. * 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);
  7. * Subjects must have received therapy for ≥3 months in the MBC setting, or for ≥6 months in the adjuvant setting, prior to progression
  8. * Progression after ≤3 lines of prior HT therapy (regardless of whether it is HT alone or in combination with other therapies)
  9. * Prior HT combination agents, including SERD, SERM or AI, must have received formal approval by regulatory agency.
  10. * ≤ 1 prior line of chemotherapy in the metastatic setting
  11. 6. Adequate organ function
  12. 7. Ability to understand and the willingness to sign a written informed consent document
  1. 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. 2. Pregnant or planning to become pregnant
  3. 3. Prior irradiation to \>25% of the bone marrow and/or inadequate bone marrow function or evidence of clinically significant end-organ damage
  4. 4. Major surgery, chemotherapy, targeted therapy, experimental agents, or radiation within 14-28 days prior to Cycle 1, Day 1
  5. 5. Active, serious medical condition that is not well controlled with locally approved medications allowed by the protocol
  6. 6. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the drugs used in the study

Contacts and Locations

Study Contact

Joanna Dojillo, MSc
CONTACT
617-315-9070
joanna.dojillo@regor.com
Regor Pharmaceuticals Central Office
CONTACT
617-315-9070
rgt-419b_01-101@regor.com

Study Locations (Sites)

Hem-Onc Associates of the Treasure Coast
Port Saint Lucie, Florida, 34952
United States
Emory University
Atlanta, Georgia, 30322
United States
Massachusetts General Hospital
Boston, Massachusetts, 02142
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
New York Cancer and Blood Specialists
Port Jefferson Station, New York, 11776
United States

Collaborators and Investigators

Sponsor: Regor Pharmaceuticals Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-04
Study Completion Date2026-09-30

Study Record Updates

Study Start Date2022-03-04
Study Completion Date2026-09-30

Terms related to this study

Keywords Provided by Researchers

  • Breast Cancer

Additional Relevant MeSH Terms

  • Breast Cancer