Testing AC699 for advanced breast cancer
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Tumor Activity of AC699 in Patients With Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Locally Advanced or Metastatic Breast Cancer
PHASE1 · Accutar Biotechnology Inc · NCT05654532
This study is testing a new oral medication called AC699 to see if it can help people with advanced breast cancer that hasn't responded to other treatments.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Accutar Biotechnology Inc (industry) |
| Drugs / interventions | chemotherapy, Radiation, prednisone |
| Locations | 5 sites (Sarasota, Florida and 4 other locations) |
| Trial ID | NCT05654532 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of AC699, an orally bioavailable estrogen receptor degrader, in patients with estrogen receptor positive and human epidermal growth factor receptor 2 negative (ER+/HER2-) locally advanced or metastatic breast cancer. It is a Phase I, first-in-human, open-label dose-escalation study aimed at determining the recommended dose of AC699 and assessing its pharmacokinetics. Participants must have advanced breast cancer that has progressed on standard treatments or for which no effective therapy exists.
Who should consider this trial
Good fit: Ideal candidates include adult postmenopausal women with ER+/HER2- breast cancer who have experienced disease progression on prior therapies.
Not a fit: Patients with early-stage breast cancer or those who have not progressed on standard therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced breast cancer who have limited therapeutic alternatives.
How similar studies have performed: Other studies involving estrogen receptor degraders have shown promise, indicating potential for success with this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed written informed consent (ICF) * Adult male and female participants, at least 18 years-of-age at the time of signature of the ICF * Female participants must be postmenopausal * Confirmed diagnosis of advanced, unresectable, and/or metastatic breast cancer following disease progression on standard treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to standard therapies * Histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive (ER+) human epidermal growth factor 2 negative (HER2-) breast cancer * Must have received at least 2 prior endocrine or at least 1 prior line of endocrine therapy if combined with CDK4/6 inhibitor * Prior chemotherapy is not required, but up to 3 prior regimens of cytotoxic chemotherapy will be allowed in the locally advanced/ metastatic setting * At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (Appendix B) or at least 1 predominantly lytic bone lesion in the absence of measurable disease * Acceptable organ and hematologic function at baseline * Life expectancy ≥12 weeks after the start of the treatment Exclusion Criteria: * Treatment with any of the following: * Any cytotoxic chemotherapy, investigational agents or other anti-cancer drugs for the treatment of locally advanced or metastatic breast cancer within 14 days prior to the first administration of AC699 * Radiation therapy within 14 days prior to first study drug administration that did not resolve to tolerable toxicity, or prior irradiation to \>25% of bone marrow. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided it has been completed 7 days prior to study enrollment and no clinically significant toxicities are expected (e.g., mucositis, esophagitis). * Major surgery within 21 days prior to the first study drug administration (exception: participants may enroll if fully recovered or without intolerable or clinically significant adverse effects but at least 14 days must have elapsed between major surgery and first study drug administration) * Known symptomatic brain metastases requiring the use of systemic corticosteroids ≥10 mg/day prednisone or equivalents. Asymptomatic and treated, or asymptomatic untreated brain metastases are allowed as long as participants are clinically stable. Stable doses of anticonvulsants are allowed. * Any condition that impairs a participant's ability to swallow whole pills. Impairment of gastrointestinal function (GI) or GI disease or other condition at baseline that will interfere significantly with the absorption, distribution, or metabolism of AC699.
Where this trial is running
Sarasota, Florida and 4 other locations
- Site 02 — Sarasota, Florida, United States (RECRUITING)
- Site 01 — Nashville, Tennessee, United States (RECRUITING)
- Site 03 — Houston, Texas, United States (RECRUITING)
- Site 05 — Norfolk, Virginia, United States (RECRUITING)
- Site 04 — Vancouver, Washington, United States (RECRUITING)
Study contacts
- Study coordinator: Accutar Biotechnology, Inc.
- Email: medical@accutarbio.com
- Phone: 908-340-0879
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Estrogen receptor-positive breast cancer, ER positive, ER+, Human epidermal growth factor receptor 2 negative, HER2 negative breast cancer, HER2-, AC699