AC682 for Advanced Breast Cancer

No longer recruiting at 6 trial locations

Overseen By Accutar Biotechnology

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Accutar Biotechnology Inc

Must not be taking: Chemotherapy, Biologics, Hormonal agents, others

Disqualifiers: Symptomatic brain metastases, GI disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 28-day cycles, up to 18 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, AC682, for individuals with a specific type of advanced breast cancer that is estrogen receptor positive and HER2 negative. The main goals are to determine the safest dose, identify side effects, understand how the body processes the drug, and evaluate its effectiveness. This trial targets postmenopausal women with this type of breast cancer and at least one measurable tumor. Participants must not have undergone recent chemotherapy or major surgery and should not have any serious conditions affecting digestion or swallowing. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial requires that you stop taking any systemic anti-cancer chemotherapy, biologic, or hormonal agents at least 4 weeks before starting AC682. If you are on systemic small molecules, you need to stop them at least 14 days or 5 half-lives (whichever is longer) before starting AC682.

Is there any evidence suggesting that AC682 is likely to be safe for humans?

Researchers are studying the safety of AC682 for individuals with certain types of advanced breast cancer. AC682 targets and breaks down the estrogen receptor protein, which some breast cancers require for growth. This novel approach is still under investigation to determine its safety.

In earlier studies with patients, the primary goal was to establish the maximum safe dosage without serious side effects. Researchers are now examining how the drug behaves in the body and identifying potential side effects. As this trial is in its early stages, detailed safety information may be limited.

Since AC682 is in early testing, its safety remains under study. Researchers aim to ensure it can be administered safely without harmful effects. Prospective trial participants should understand that while early studies provide some insights, a comprehensive safety profile will emerge with further research. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for advanced breast cancer, which often includes hormone therapies, chemotherapy, and targeted treatments like HER2 inhibitors, AC682 is unique because it is administered as a monotherapy with a novel mechanism of action. Researchers are excited about AC682 because it targets specific pathways involved in cancer cell growth that current treatments may not directly address. This targeted approach has the potential to be more effective and possibly reduce some side effects associated with broader-acting treatments.

What evidence suggests that AC682 might be an effective treatment for advanced breast cancer?

Research has shown that AC682, the investigational treatment in this trial, may help treat certain types of breast cancer. In a previous study, 40% of patients with similar cancer types experienced positive effects from the treatment. These results are promising for those with a specific type of breast cancer called estrogen receptor positive/human epidermal growth factor 2 negative (ER+/HER2-). Although more research is needed, early findings suggest that AC682 might help manage the disease in some patients. ^{1 6 7 8 9}

Who Is on the Research Team?

Erika Hamilton

Principal Investigator

Tennessee Oncology

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

My organs are functioning well.

Patients with life expectancy ≥3 months

Exclusion Criteria

I haven't used growth factors or had blood transfusions in the last 14 days.

I haven't taken any cancer drugs from a study or past treatment in the last 14 days or more.

I have not had major surgery in the last 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AC682 monotherapy in 28-day cycles to evaluate safety, tolerability, and pharmacokinetics

28-day cycles, up to 18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AC682

Trial Overview 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.

How Is the Trial Designed?

Group I: AC682 Experimental Treatment 1 Intervention

This arm will evaluate AC682 monotherapy administered in 28-day cycles. Up to 30 participants will participate in this dose escalation arm.

Who Is Running the Clinical Trial?

Accutar Biotechnology Inc

Lead Sponsor

Trials

6

Recruited

180+

Published Research Related to This Trial

HER2-positive breast cancer, which affects about 20% of patients, has seen improved outcomes with new targeted therapies like trastuzumab and pertuzumab, especially in first-line treatment.

Emerging therapies such as tucatinib and fam-trastuzumab deruxtecan are expanding treatment options for advanced HER2-positive breast cancer, with ongoing research into biomarkers to enhance patient selection and address specific needs like brain metastasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current and Future Management of HER2-Positive Metastatic Breast Cancer. Martínez-Sáez, O., Prat, A.[2022]

In a real-life study of 233 patients with advanced breast cancer who had PIK3CA mutations, treatment with alpelisib and fulvestrant resulted in a median progression-free survival (PFS) of 5.3 months, indicating its efficacy even after multiple prior treatments.

However, 39.1% of patients discontinued alpelisib due to adverse events, highlighting the importance of monitoring for side effects in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alpelisib and fulvestrant in PIK3CA-mutated hormone receptor-positive HER2-negative advanced breast cancer included in the French early access program. Bello Roufai, D., Gonçalves, A., De La Motte Rouge, T., et al.[2023]

In a study of 2657 early breast cancer (EBC) and 535 metastatic breast cancer (MBC) patients, those with intermediate HER2 expression (IHC 2+) had significantly poorer recurrence-free survival compared to HER2-negative patients, particularly in those aged 55 and older.

Intermediate HER2 expression serves as an independent predictor of poor prognosis in both ER+ EBC and MBC patients aged 55 and older, suggesting that new HER2-targeting therapies like DS8201 may be particularly important for this high-risk group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermediate HER2 expression is associated with poor prognosis in estrogen receptor-positive breast cancer patients aged 55 years and older. Kim, MH., Kim, GM., Kim, JH., et al.[2020]

Novel antibody-drug conjugates (ADCs) like trastuzumab-deruxtecan and trastuzumab-duocarmazine show promising clinical activity in HER2-positive metastatic breast cancer, even in patients who have been previously treated and in those with low HER2 expression.

ZW25, a bispecific HER2-directed antibody, demonstrated excellent tolerability and significant activity as a single agent, indicating its potential as a new treatment option for patients with HER2-positive tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ASCO 2018: highlights in HER2-positive metastatic breast cancer. Bartsch, R., Bergen, E.[2022]

Citations

1. withpower.com withpower.com/trial/phase-1-breast-neoplasms-10-2021-bc67f

AC682 for Advanced Breast Cancer · Info for Participants HER2-positive breast cancer, which affects about 20% of patients, has seen improved outcomes with new targeted therapies like trastuzumab and pertuzumab, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05080842

A Study of AC682 for the Treatment of Locally Advanced ... This clinical trial is evaluating a drug called AC682 in participants with estrogen receptor positive/human epidermal growth factor 2 negative (ER+/HER2-) ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10566586/

Clinician's guide to targeted estrogen receptor degradation ... Promising clinical activity was demonstrated with a clinical benefit rate of 40% (95% CI, 26–56) in 47 evaluable patients. In 2022, the results ...

4. targetedonc.com targetedonc.com/view/emerging-therapies-in-breast-cancer-excite-the-field

Emerging Therapies in Breast Cancer Excite the Field Among trial participants with TNBC, there was an objective response rate (ORR) of 32%, a disease control rate (DCR) of 64%, and a median PFS of ...

5. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-11222

A Study of AC682 for the Treatment of Locally Advanced ... This clinical trial is evaluating a drug called AC682 in participants with estrogen receptor positive/human epidermal growth factor 2 negative (ER+/HER2-) ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05489679

A Study of AC682 In Chinese Patients With ER+/HER2- ... This clinical trial is evaluating AC682 in participants with estrogen receptor positive/human epidermal growth factor 2 negative (ER+/HER2-) locally advanced or ...

7. ctv.veeva.com ctv.veeva.com/study/a-study-of-ac682-for-the-treatment-of-locally-advanced-or-metastatic-er-breast-cancer

A Study of AC682 for the Treatment of Locally Advanced or ... This clinical trial is evaluating a drug called AC682 in participants with estrogen receptor positive/human epidermal growth factor 2 ...

8. clin.larvol.com clin.larvol.com/trial-detail/NCT05080842

A Study of AC682 for the Treatment of Locally Advanced ... The purpose of the Phase 1 multi-center, open-label study is to assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of AC0682 ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9340905/

Next-generation selective estrogen receptor degraders and ... AC682 is an oral chimeric ER degrader in development by Accutar Biotech that engages E3 ligase and ER to induce receptor degradation.