AC682 for Advanced Breast Cancer

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

21 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new oral drug called AC682 for patients with advanced breast cancer that grows in response to estrogen. The drug aims to break down estrogen receptors on cancer cells to stop their growth.

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.

What data supports the effectiveness of the drug AC682 for advanced breast cancer?

The research highlights the effectiveness of antibody-drug conjugates like RC48 and DS8201, which target HER2-positive breast cancer, similar to AC682. These treatments have shown benefits in targeting cancer cells while minimizing damage to healthy cells, suggesting potential effectiveness for AC682 in advanced breast cancer. ^{1 2 3 4 5}

What makes AC682 unique for advanced breast cancer treatment?

AC682 is unique because it may represent a novel approach in targeting HER2-positive breast cancer, potentially offering a new option beyond existing treatments like trastuzumab and pertuzumab. While specific details about AC682 are not provided, it could involve innovative mechanisms or combinations that differ from current therapies. ^{1 5 6 7 8}

Research Team

Erika Hamilton

Principal Investigator

Tennessee Oncology

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Disitamab Vedotin (RC48) for HER2-positive advanced breast cancer: a case report and literature review. [2023]

2. England 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. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Comparative review of pharmacological therapies in individuals with HER2-positive advanced breast cancer with focus on hormone receptor subgroups. [2023]

4. Netherlands 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. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Current and Future Management of HER2-Positive Metastatic Breast Cancer. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Targeting HER2 in breast cancer: new drugs and paradigms on the horizon. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Systemic therapy for metastatic HER2-positive breast cancer. [2021]

8. Austria pubmed.ncbi.nlm.nih.gov

ASCO 2018: highlights in HER2-positive metastatic breast cancer. [2022]