BridgeMD
New treatment option for Breast Cancer
Official title FIH Study of RGT-419B Alone and With Endocrine Therapy in HR-Positive, HER2-Negative Advanced/Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT05304962
What this study is testing
What is RGT-419B?
RGT-419B is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female \>/= 18 years old
- ECOG Performance Status 0 to 1
- people must have histologically or cytologically confirmed diagnosis of ER+, HER2- ABC consistent with ASCO CAP guidelines that is locally advanced...
- Measurable AND evaluable lesions at baseline per RECIST v1.1.
- Eligible people must meet all of the following criteria:
You likely can't join if
- Presence of visceral metastases with severe organ dysfunction as evidence by signs and symptoms, laboratory studies, lymphangitic spread and/or rapid...
- Pregnant or planning to become pregnant
- Prior irradiation to \>25% of the bone marrow and/or inadequate bone marrow function or evidence of clinically significant end-organ damage
- Major surgery, chemotherapy, targeted therapy, experimental agents, or radiation within 14-28 days prior to Cycle 1, Day 1
- Active, serious medical condition that is not well controlled with locally approved medications allowed by the protocol
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the drugs used in the study
See the full eligibility criteria
- Male or female \>/= 18 years old
- ECOG Performance Status 0 to 1
- people 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.
- Measurable AND evaluable lesions at baseline per RECIST v1.1.
- Eligible people 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...
- people 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
- Adequate organ function
- Ability to understand and the willingness to sign a written informed consent document
- Presence of visceral metastases with severe organ dysfunction as evidence by signs and symptoms, laboratory studies, lymphangitic spread and/or rapid progression of disease
- Pregnant or planning to become pregnant
- Prior irradiation to \>25% of the bone marrow and/or inadequate bone marrow function or evidence of clinically significant end-organ damage
- Major surgery, chemotherapy, targeted therapy, experimental agents, or radiation within 14-28 days prior to Cycle 1, Day 1
- Active, serious medical condition that is not well controlled with locally approved medications allowed by the protocol
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the drugs used in the study
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
- Los Angeles, California, United States
- Port Saint Lucie, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- Port Jefferson Station, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States; Los Angeles, California, United States; Port Saint Lucie, Florida, United States; Tampa, Florida, United States; Atlanta, Georgia, United States; Boston, Massachusetts, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.