AC699 for Breast Cancer

Not currently recruiting at 8 trial locations

Overseen By Accutar Biotechnology, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Accutar Biotechnology Inc

Must not be taking: Cytotoxic chemotherapy, Investigational agents

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: 4 weeks per cycle

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, AC699, for individuals with a specific type of advanced or metastatic breast cancer (ER+/HER2-). The study aims to determine a safe dose, understand the drug's behavior in the body, and assess its effectiveness. It seeks postmenopausal women and men who have tried other cancer treatments but need new options. Participants should have inoperable breast cancer and at least one measurable tumor. 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 cytotoxic chemotherapy, investigational agents, or other anti-cancer drugs for breast cancer at least 14 days before starting AC699. If you are on radiation therapy, it must be completed 7 days before enrollment, and major surgery must be at least 14 days prior.

Is there any evidence suggesting that AC699 is likely to be safe for humans?

In a previous study, researchers found that AC699 was safe and tolerable for patients taking doses up to 300 mg. Early results suggest that patients generally tolerated AC699 well, with no major safety issues reported. Trials with patients who have a specific type of breast cancer observed these findings. While this is early data, it positively indicates that AC699 might be safe for further testing in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for breast cancer, like chemotherapy and hormone therapy, work by targeting rapidly dividing cells or blocking hormones that fuel cancer growth. But AC699 works differently, aiming directly at specific molecular pathways involved in tumor growth. This targeted approach has the potential to be more precise, potentially reducing side effects compared to traditional treatments. Researchers are excited about AC699 because it could offer a more personalized treatment option for breast cancer patients, focusing on the unique characteristics of their cancer cells.

What evidence suggests that AC699 might be an effective treatment for breast cancer?

Earlier studies have shown promising results for AC699 in treating certain types of breast cancer. Research indicates that 42% of patients experienced positive effects, such as the cancer not worsening, after treatment with AC699. Initial findings suggest that AC699 is safe and tolerable at doses up to 300 mg, with some patients even taking higher doses. This drug targets and breaks down estrogen receptors, which can help slow or stop the growth of cancer cells in estrogen receptor positive (ER+) breast cancer. These promising early results support further research into AC699's effectiveness. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My breast cancer is advanced, can't be surgically removed, and has worsened after standard treatment.

I have gone through menopause.

My organs are functioning well and my blood tests are normal.

Exclusion Criteria

I haven't had major radiation therapy or unresolved side effects in the last 14 days.

I have not had major surgery in the last 21 days or have fully recovered from one within the last 14 days.

I haven't taken any cancer drugs for my advanced breast cancer in the last 14 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AC699 monotherapy during dose escalation. One cycle is defined as 28 days.

4 weeks per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AC699

Trial Overview 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.

How Is the Trial Designed?

Group I: AC699 Dose Escalation Experimental Treatment 1 Intervention

Participants will receive an assigned dose of AC699 monotherapy during dose escalation. One cycle is defined as 28 days.

Who Is Running the Clinical Trial?

Accutar Biotechnology Inc

Lead Sponsor

Trials

6

Recruited

180+

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.3074

Preliminary results from a phase 1 study of AC699, an ... Preliminary data from the ongoing phase 1 trial evaluating AC699 indicate promising safety, tolerability, and anti-tumor activity, at doses up to 300 mg orally ...

2. aacrjournals.org aacrjournals.org/clincancerres/article/31/12_Supplement/P4-10-28/752175/Abstract-P4-10-28-Efficacy-safety-and-biomarker

Efficacy, safety and biomarker results of AC699, a chimeric ... Safety, efficacy and biomarker data from an ongoing phase 1 dose escalation trial of AC699 is presented here (NCT05654532).

3. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)02223-3/fulltext

637P AC699, a novel chimeric estrogen receptor degrader, ... A total of 29 patients had received AC699 at four dose levels (100, 200, 300, 400 mg) at the time of the data cutoff. The median lines of prior therapy were 5 ( ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05654532

Study of AC699 in Patients With Estrogen Receptor ... This clinical trial is evaluating a drug called AC699 in participants with estrogen receptor positive/human epidermal growth factor 2 negative (ER+/HER2-) ...

5. cancernetwork.com cancernetwork.com/view/fda-grants-fast-track-designation-for-ac699-in-er-her2--breast-cancer

FDA Grants Fast Track Designation for AC699 in ER+/HER2 Furthermore, the clinical benefit rate (CBR) was 42% (n = 5/12) among this patient group and included patients with stable disease for 24 or ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05654532

Study of AC699 in Patients With Estrogen Receptor ... This clinical trial is evaluating a drug called AC699 in participants with estrogen receptor positive/human epidermal growth factor 2 negative (ER+/HER2-) ...