← Back to Search

Other

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

At least 1 measurable lesion that meets the definition in Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 or at least 1 non-target lesion is required.

Patients who have adequate organ functions at baseline

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

Select...

I have at least one tumor that can be measured by medical imaging.

Select...

My organs are functioning well.

Select...

I am fully active or have some restrictions but can still care for myself.

Select...

My breast cancer is ER+ and HER2-.

Select...

I am 18 years old or older.

Select...

I am a woman and have gone through menopause.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, approximately 18 months

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.

0 / 6Eligibility criteria met

Find a Location

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

Frequently Asked Questions

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

How many venues are hosting this clinical experiment?

"The 6 clinical sites administering this study comprise of Sarah Cannon Research Institute at HealthONE in Denver, Site 04 in Orlando and Site 02 in Sarasota as well as additional medical centres."

Answered by AI

How many participants are currently engaging in this research project?

"The trial sponsor, Accutar Biotechnology Inc., necessitates the recruitment of 30 qualifying patients to begin the study. The research will be conducted from locations such as Sarah Cannon Research Institute at HealthONE in Denver and Site 04 located in Orlando, Florida."

Answered by AI

Are participants currently being accepted for this experiment?

"Affirmative. As indicated on clinicaltrials.gov, this clinical trial - which was initially posted on November 12th 2021- is actively looking for volunteers. This study seeks 30 participants across 6 sites."

Answered by AI