Evaluating RGT-419B for advanced breast cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase I, First-in-Human study aims to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of RGT-419B, both as a standalone treatment and in combination with hormonal therapy, for patients with HR-positive, HER2-negative advanced or metastatic breast cancer. Participants must have experienced disease progression after prior treatment with a CDK4/6 inhibitor and hormonal therapy. The study will involve oral administration of RGT-419B to determine its effectiveness in this patient population.

Why it matters

Who can join: the full rules

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

Where it's running

• University of California, San Diego
  La Jolla, California, United States Recruiting
• University California, Los Angeles
  Los Angeles, California, United States Recruiting
• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting
• Emory University
  Atlanta, Georgia, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Washington University School of Medicine
  St Louis, Missouri, United States Recruiting

Study contacts

• Study coordinator: Joanna Dojillo, MSc
• Email: joanna.dojillo@regor.com
• Phone: 617-315-9070

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.