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Selective Estrogen Receptor Modulator

AC699 for Breast Cancer

Phase 1
Recruiting
Research Sponsored by Accutar Biotechnology Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Confirmed diagnosis of advanced, unresectable, and/or metastatic breast cancer following disease progression on standard treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to standard therapies
Female participants must be postmenopausal
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 18 months.
Awards & highlights

Study Summary

This trial is testing a drug for breast cancer to determine its safety, dosage and effectiveness.

Who is the study for?
This trial is for adults with ER+/HER2- advanced or metastatic breast cancer who have tried at least one line of endocrine therapy. They must be able to swallow pills, have no major GI issues affecting drug absorption, and should not have symptomatic brain metastases requiring high-dose steroids.Check my eligibility
What is being tested?
The study tests AC699's safety, tolerable dosing levels, how the body processes it (pharmacokinetics), and its effectiveness in treating breast cancer. Participants will receive AC699 to determine these outcomes.See study design
What are the potential side effects?
While specific side effects of AC699 are not listed here, common ones may include reactions at the pill intake site, gastrointestinal disturbances due to oral administration, fatigue from treatment burden, and potential organ-specific inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer is advanced, can't be surgically removed, and has worsened after standard treatment.
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I have gone through menopause.
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My organs are functioning well and my blood tests are normal.
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I may have had up to 3 chemotherapy treatments for my advanced cancer.
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I have at least one tumor that can be measured or a specific type of bone lesion.
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My breast cancer is ER+ and HER2-.
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I have had at least 2 hormone therapies or 1 with a CDK4/6 inhibitor for my cancer.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 18 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 18 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of dose limiting toxicities (DLTs) from AC699 monotherapy
Incidence of treatment-emergent adverse events (TEAEs) and clinically significant Grade 3 or higher lab abnormalities following administration of AC699
Secondary outcome measures
Clinical Benefit Rate (CBR) to assess the anti-tumor activity of AC699 using RECIST 1.1
Disease Control Rate (DCR) to assess the anti-tumor activity of AC699 using RECIST 1.1
Duration of Response (DOR) to assess the anti-tumor activity of AC699 using RECIST 1.1
+7 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: AC699 Dose EscalationExperimental Treatment1 Intervention
Participants will receive an assigned dose of AC699 monotherapy during dose escalation. One cycle is defined as 28 days.

Find a Location

Who is running the clinical trial?

Accutar Biotechnology IncLead Sponsor
5 Previous Clinical Trials
123 Total Patients Enrolled
2 Trials studying Breast Cancer
27 Patients Enrolled for Breast Cancer

Media Library

AC699 (Selective Estrogen Receptor Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT05654532 — Phase 1
Breast Cancer Research Study Groups: AC699 Dose Escalation
Breast Cancer Clinical Trial 2023: AC699 Highlights & Side Effects. Trial Name: NCT05654532 — Phase 1
AC699 (Selective Estrogen Receptor Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05654532 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What risks have been identified with AC699 Dose Escalation?

"The safety of AC699 Dose Escalation has been assessed at a 1 on our team's scale due to the limited data surrounding its efficacy and overall security."

Answered by AI

Are there currently any open enrollment opportunities for this experiment?

"Affirmative. Clinicaltrials.gov documents this trial, initially launched on December 29th 2022, is still actively enrolling participants. The study needs to source 60 individuals across just two medical sites."

Answered by AI

What is the present size of this clinical trial's participant roster?

"Affirmative. Clinicaltrials.gov shows that this scientific research, initially posted on December 29th 2022, is actively recruiting patients. 60 individuals need to be enlisted from two trial sites across the country."

Answered by AI
~9 spots leftby Jul 2024