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AC682 for Advanced Breast Cancer

Phase 1
Waitlist Available
Research Sponsored by Accutar Biotechnology Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
Histologically and/or cytologically confirmed advanced estrogen receptor positive (ER+) human epidermal growth factor 2 negative (HER2-) breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, approximately 18 months
Awards & highlights

Study Summary

This trial is testing a new drug, AC682, for people with a certain type of breast cancer. The goals are to see how safe it is, what side effects it has, how it works in the body, and how well it works against the cancer.

Who is the study for?
This trial is for postmenopausal women over 18 with advanced ER+/HER2- breast cancer, who are in good health with a life expectancy of at least 3 months. They must have measurable cancer lesions and not have had recent cancer treatments or surgeries, nor any condition affecting drug absorption.Check my eligibility
What is being tested?
AC682 is being tested to find the safest dose, understand side effects, how the body processes it (pharmacokinetics), and its effectiveness against advanced ER+/HER2- breast cancer. Participants will receive AC682 as part of this evaluation process.See study design
What are the potential side effects?
While specific side effects of AC682 aren't listed here, common ones may include reactions at the injection site, fatigue, nausea, changes in blood counts leading to increased infection risk or bleeding tendencies. Each participant's experience can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or have some restrictions but can still care for myself.
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My breast cancer is ER+ and HER2-.
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I am 18 years old or older.
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I am a woman and have gone through menopause.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, approximately 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, 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)
Incidence of treatment-emergent adverse events (TEAEs), and clinically significant grade 3 or higher laboratory abnormalities following administration of AC682
Secondary outcome measures
Clinical benefit rate (CBR) as a measure of anti-tumor activity
Disease control rate (DCR) as a measure of anti-tumor activity
Duration of response (DOR) as a measure of anti-tumor activity
+7 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: AC682Experimental Treatment1 Intervention
This arm will evaluate AC682 monotherapy administered in 28-day cycles. Up to 30 participants will participate in this dose escalation arm.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for ER+/HER2- breast cancer include selective estrogen receptor modulators (SERMs) like tamoxifen, aromatase inhibitors (AIs) such as letrozole and anastrozole, and selective estrogen receptor degraders (SERDs) like fulvestrant. These therapies work by blocking the estrogen receptor, reducing estrogen production, or degrading the receptor, thereby inhibiting the growth of estrogen-dependent cancer cells. This is crucial for patients with ER+/HER2- breast cancer as these tumors rely on estrogen signaling for growth and proliferation. Understanding these mechanisms helps in tailoring effective treatment plans and managing resistance to therapy.
Exploring the Molecular Mechanism of the Drug-Treated Breast Cancer Based on Gene Expression Microarray.Progesterone receptor assembly of a transcriptional complex along with activator protein 1, signal transducer and activator of transcription 3 and ErbB-2 governs breast cancer growth and predicts response to endocrine therapy.Resistance to endocrine therapy in breast cancer: exploiting estrogen receptor/growth factor signaling crosstalk.

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Who is running the clinical trial?

Accutar Biotechnology IncLead Sponsor
5 Previous Clinical Trials
162 Total Patients Enrolled
2 Trials studying Breast Cancer
66 Patients Enrolled for Breast Cancer
Erika HamiltonStudy ChairTennessee Oncology
1 Previous Clinical Trials
45 Total Patients Enrolled

Media Library

AC682 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05080842 — Phase 1
~6 spots leftby Jun 2025
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