AC699 for Breast Cancer

Recruiting at 4 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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing AC699, a new oral drug, in patients with a specific type of advanced breast cancer. AC699 works by breaking down estrogen receptors, which helps to stop the cancer from growing. Another drug being tested is AZD9496, which also targets estrogen receptors to prevent cancer growth.

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+