Breast CancerPhase 1NCT05080842
A Study of AC682 for the Treatment of Locally Advanced or Metastatic ER+ Breast Cancer
A Phase 1 study testing AC682 in people with Breast Cancer, run by Accutar Biotechnology Inc at 5 sites in United States.
Trial summary
This clinical trial is evaluating a drug called AC682 in participants with estrogen receptor positive/human epidermal growth factor 2 negative (ER+/HER2-) locally advanced or metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- AC682
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 5 sitesUnited States
- Study dates
- 12 Nov 2021to 4 Apr 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent form (ICF)
- Patients must be ≥18 years-of-age at the time of signing of the ICF
- Female patients must be postmenopausal
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- Histologically and/or cytologically confirmed advanced estrogen receptor positive (ER+) human epidermal growth factor 2 negative (HER2-) breast cancer
- Patients with life expectancy ≥3 months
- Patients who have adequate organ functions at baseline
- At least 1 measurable lesion that meets the definition in Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 or at least 1 non-target lesion is required.
Who cannot join
- Treatment with any of the following: systemic anti-cancer chemotherapy, biologic, or hormonal agent from a previous treatment regimen or clinical study within 4 weeks prior to the first dose of AC682; systemic small molecules from a previous treatment regimen or clinical study within 14 days or 5 half-lives (whichever is longer) prior to the first dose of AC682 (at least 10 days must have elapsed between the last dose of such agent and the first dose of study drug)
- Radiation therapy such as wide-field radiotherapy administered ≤28 days of first dose of AC682
- Major surgery (excluding placement of vascular access) within 4 weeks of first dose of AC682
- Known symptomatic brain metastases requiring the use of steroids
- Any condition that impairs a patient'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 AC682.
- Use of prophylactic growth factors and blood transfusions ≤14 days prior to the first dose of AC682 and during dose limiting toxicity observation period
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Site 01
Denver, Colorado, 80218
Site 05
Houston, Texas, 77030
Site 03
Nashville, Tennessee, 37203
Site 04
Orlando, Florida, 32827
Site 02
Sarasota, Florida, 34232
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Tumor Activity of AC682 in Patients With Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Locally Advanced or Metastatic Breast Cancer
This clinical trial is evaluating a drug called AC682 in participants with estrogen receptor positive/human epidermal growth factor 2 negative (ER+/HER2-) locally advanced or metastatic breast cancer. The main goals of this study are to:
- Identify the recommended dose of AC682 that can be given safely to participants
- To evaluate the side effects of AC682
- To evaluate pharmacokinetics of AC682
- To evaluate the effectiveness of AC682
Read the detailed description
This is a Phase I, first in human, open-label dose-escalation study of AC682, an orally available estrogen receptor degrader, given as a single agent.
- Conditions
- Breast Cancer
- Being tested
- AC682
- Keywords
- Estrogen receptor positive, ER positive, ER+, Human epidermal growth factor receptor 2 negative, HER2 negative, HER2-, AC682, Breast cancer, Phase I
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AC682Drug
Participants will receive AC682 by mouth daily in 28-day cycles.
| Study group | Role | What they receive |
|---|---|---|
| AC682 | Experimental | This arm will evaluate AC682 monotherapy administered in 28-day cycles. Up to 30 participants will participate in this dose escalation arm. Receives: Drug: AC682 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting toxicities (DLTs)
Measured: 28 days (Cycle 1)
Incidence of treatment-emergent adverse events (TEAEs), and clinically significant grade 3 or higher laboratory abnormalities following administration of AC682
Adverse events will be graded according to NCI CTCAE v5.0.
Measured: Through study completion, approximately 18 months
Secondary outcomes (10)
Objective response rate (ORR) as a measure of anti-tumor activity
Measured: Through study completion, approximately 18 months
Clinical benefit rate (CBR) as a measure of anti-tumor activity
Measured: Through study completion, approximately 18 months
Duration of response (DOR) as a measure of anti-tumor activity
Measured: Through study completion, approximately 18 months
Disease control rate (DCR) as a measure of anti-tumor activity
Measured: Through study completion, approximately 18 months
Progression free survival (PFS) as a measure of anti-tumor activity
Measured: Through study completion, approximately 18 months
Pharmacokinetic Analysis: area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC(0-inf))
Measured: Through study completion, approximately 18 months
Pharmacokinetic Analysis: area under the concentration-time curve over the dosing interval (AUC(0-tau))
Measured: Through study completion, approximately 18 months
Pharmacokinetic Analysis: maximum plasma concentration (Cmax)
Measured: Through study completion, approximately 18 months
Pharmacokinetic Analysis: time to maximum plasma concentration (tmax)
Measured: Through study completion, approximately 18 months
Pharmacokinetic Analysis: terminal elimination half life (t1/2)
Measured: Through study completion, approximately 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start12 Nov 2021
- Primary completion4 Apr 2024
- Study completion4 Apr 2024
Why it stopped: Voluntarily terminate the study since the sponsor's development strategy was adjusted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Accutar Biotechnology Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080842
- Sponsor's protocol ID
- AC682-001
- Status last verified
- Feb 2025
- First submitted
- 22 Sep 2021
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Tumor Activity of AC682 in Patients With Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Locally Advanced or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT05080842
- Acronym / sponsor ID
- AC682-001
- Conditions
- Breast Cancer
- Keywords
- Estrogen receptor positive, ER positive, ER+, Human epidermal growth factor receptor 2 negative, HER2 negative, HER2-, AC682, Breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Voluntarily terminate the study since the sponsor's development strategy was adjusted.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Accutar Biotechnology IncIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2021 (actual)
- Primary completion
- 4 Apr 2024 (actual)
- Study completion
- 4 Apr 2024 (actual)
- First posted
- 18 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial is evaluating a drug called AC682 in participants with estrogen receptor positive/human epidermal growth factor 2 negative (ER+/HER2-) locally advanced or metastatic breast cancer. The main goals of this study are to:
- Identify the recommended dose of AC682 that can be given safely to participants
- To evaluate the side effects of AC682
- To evaluate pharmacokinetics of AC682
- To evaluate the effectiveness of AC682
Detailed description
This is a Phase I, first in human, open-label dose-escalation study of AC682, an orally available estrogen receptor degrader, given as a single agent.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AC682 | Experimental | Drug: AC682This arm will evaluate AC682 monotherapy administered in 28-day cycles. Up to 30 participants will participate in this dose escalation arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed written informed consent form (ICF)
- Patients must be ≥18 years-of-age at the time of signing of the ICF
- Female patients must be postmenopausal
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- Histologically and/or cytologically confirmed advanced estrogen receptor positive (ER+) human epidermal growth factor 2 negative (HER2-) breast cancer
Key exclusion criteria (6 listed)
- Treatment with any of the following: systemic anti-cancer chemotherapy, biologic, or hormonal agent from a previous treatment regimen or clinical study within 4 weeks prior to the first dose of AC682; systemic small molecules from a previous treatment regimen or clinical study within 14 days or 5 half-lives (whichever is longer) prior to the first dose of AC682 (at least 10 days must have elapsed between the last dose of such agent and the first dose of study drug)
- Radiation therapy such as wide-field radiotherapy administered ≤28 days of first dose of AC682
- Major surgery (excluding placement of vascular access) within 4 weeks of first dose of AC682
- Known symptomatic brain metastases requiring the use of steroids
- Any condition that impairs a patient'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 AC682.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AC682Participants will receive AC682 by mouth daily in 28-day cycles. | Drug | AC682 |
Primary outcome
Incidence of dose limiting toxicities (DLTs)
Time frame: 28 days (Cycle 1)
Incidence of treatment-emergent adverse events (TEAEs), and clinically significant grade 3 or higher laboratory abnormalities following administration of AC682
Time frame: Through study completion, approximately 18 months
Adverse events will be graded according to NCI CTCAE v5.0.
10 secondary outcomes
Objective response rate (ORR) as a measure of anti-tumor activity
Time frame: Through study completion, approximately 18 months
Clinical benefit rate (CBR) as a measure of anti-tumor activity
Time frame: Through study completion, approximately 18 months
Duration of response (DOR) as a measure of anti-tumor activity
Time frame: Through study completion, approximately 18 months
Disease control rate (DCR) as a measure of anti-tumor activity
Time frame: Through study completion, approximately 18 months
Progression free survival (PFS) as a measure of anti-tumor activity
Time frame: Through study completion, approximately 18 months
Pharmacokinetic Analysis: area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC(0-inf))
Time frame: Through study completion, approximately 18 months
Pharmacokinetic Analysis: area under the concentration-time curve over the dosing interval (AUC(0-tau))
Time frame: Through study completion, approximately 18 months
Pharmacokinetic Analysis: maximum plasma concentration (Cmax)
Time frame: Through study completion, approximately 18 months
Pharmacokinetic Analysis: time to maximum plasma concentration (tmax)
Time frame: Through study completion, approximately 18 months
Pharmacokinetic Analysis: terminal elimination half life (t1/2)
Time frame: Through study completion, approximately 18 months
Results and safety
The study was stopped early (reason given: Voluntarily terminate the study since the sponsor's development strategy was adjusted.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AC682 in people with Breast Cancer, run by Accutar Biotechnology Inc at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Voluntarily terminate the study since the sponsor's development strategy was adjusted.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose limiting toxicities (DLTs) (time frame: 28 days (Cycle 1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.