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RGT-419B + Hormonal Therapy for Breast Cancer
Phase 1
Recruiting
Research Sponsored by Regor Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
HR+, HER2- tumor by most recent biopsy with measurable disease
ECOG Performance Status 0 to 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial is testing a new drug, RGT-419B, for safety and how well it works in people with breast cancer that has progressed despite prior treatment. The study will also look at how the drug is processed by the body.
Who is the study for?
This trial is for adults with HR+, HER2- advanced or metastatic breast cancer who've had no more than one prior chemotherapy in this setting and less than three lines of CDK4/6i therapy. Participants must have an ECOG Performance Status of 0 to 1, indicating they are fully active or restricted in physically strenuous activity but ambulatory.Check my eligibility
What is being tested?
The study tests RGT-419B, a new oral medication, alone or combined with hormonal therapy. It's a phase I trial focusing on safety, how the body processes the drug (pharmacokinetics), and its initial effectiveness against certain types of breast cancer that progressed after previous treatments.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical ones may include reactions related to immune system activation such as fatigue, nausea, skin issues; hormone-related changes; and potential impacts on liver function. Side effects will be closely monitored due to the early stage of testing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tumor is HR positive, HER2 negative, and can be measured.
Select...
I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety & Tolerability - Number of subjects with Dose-Limiting Toxicities (DLTs) at each cohort dose level in singlet and doublet therapy
Secondary outcome measures
Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Accumulation rate after multiple doses
Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Area Under Concentration-Time Curve (AUC0-t)
Brain Diseases, Metabolic
+7 moreOther outcome measures
Symptom Burden
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm BExperimental Treatment1 Intervention
RGT-419B in combination with Hormonal Therapy
Group II: Arm AExperimental Treatment1 Intervention
RGT-419B given alone as monotherapy
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Who is running the clinical trial?
Regor Pharmaceuticals Inc.Lead Sponsor
4 Previous Clinical Trials
173 Total Patients Enrolled
1 Trials studying Breast Cancer
40 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to my organs, causing severe problems.I haven't had major surgery or cancer treatment in the last 14 days.My tumor is HR positive, HER2 negative, and can be measured.I've had only one chemotherapy for advanced breast cancer, tolerated CDK4/6 inhibitors well, can take RT-419B, and recovered from past therapy side effects.I have not had radiation to more than a quarter of my bone marrow and my organs are functioning well.I have a serious health condition that isn't well-managed with medication.I have advanced breast cancer, tried <3 CDK4/6i therapies, and no more than 1 chemotherapy.I've had at least one hormone therapy for my cancer and can have it again.I am fully active or can carry out light work.You have had allergic reactions to similar drugs in the past.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A
- Group 2: Arm B
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment for this clinical trial still available?
"Per clinicaltrials.gov, this trial is actively seeking participants. The initial posting date was March 4th 2022 and the most recent update happened on April 18th 2022."
Answered by AI
Has RGT-419B been given the regulatory green light for use?
"RGT-419B has yet to be extensively tested in clinical trials, thus the safety of this drug is classified as a 1 on our team's rating system."
Answered by AI
How many individuals are partaking in this medical research?
"Affirmative. Clinicaltrials.gov showcases this medical trial as actively enrolling patients, with the first advertisement posted on March 4th 2022 and last modified April 18th 2022. In total, 48 individuals are needed from one facility to participate in the study."
Answered by AI
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