Breast CancerPhase 1NCT05489679
A Study of AC682 In Chinese Patients With ER+/HER2- Locally Advanced or Metastatic Breast Cancer
A Phase 1 study testing AC682 in people with Breast Cancer, run by Accutar Biotechnology Inc at 3 sites in China.
Trial summary
This clinical trial is evaluating 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: 1. To evaluate the safety and tolerability of AC682 2. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- 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
- 6 participants
- Where
- 3 sitesChina
- Study dates
- 1 Oct 2022to 28 Sep 2023
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be ≥18 years-of-age at the time of signing of the ICF
- Histologically and/or cytologically confirmed advanced estrogen receptor positive (ER+) human epidermal growth factor 2 negative (HER2-) breast cancer
- Female patients must be postmenopausal
- At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 or at least 1 predominantly lytic bone lesion in the absence of measurable disease
- Previously received at least 1 endocrine therapy regimen; concomitant use of cyclin-dependent kinase (CDK) 4/6 inhibitor(s) is acceptable; Previous chemotherapy is not required, but up to 2 prior regimens of cytotoxic chemotherapy is allowed.
- Patients who have adequate organ functions at baseline
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)
- Received radiotherapy (including radioactive isotope therapy) within 4 weeks prior to the first dose of AC682
- Major surgery (excluding placement of vascular access) within 4 weeks of first dose of AC682
- With known metastasis to the brain
- 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
3 sites in 1 country.
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumor Activity of AC682 In Chinese Patients With ER+/HER2- Locally Advanced or Metastatic Breast Cancer
This clinical trial is evaluating 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:
- To evaluate the safety and tolerability of AC682
- To evaluate the pharmacokinetic of AC682
- To evaluate the preliminary anti-tumor activity of AC682
Read the detailed description
This is a Phase I, 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, AC682, 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. The 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) from AC682 monotherapy
Number of subjects with DLT
Measured: 28 days
Incidence of treatment emergent adverse events(TEAEs) from AC682 monotherapy
Number of adverse events as characterized by type, frequency, seriousness, and relationship to AC682
Measured: Throughout the study completion, approximately 24 months
Secondary outcomes (10)
To determine the PK of AC682 after a single dose or multiple doses:
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC(0-inf))
Measured: At predefined intervals throughout the study completion, approximately 24 months.
To determine the PK of AC682 after a single dose or multiple doses:
Area under the concentration-time curve over the dosing interval (AUC(0-tau))
Measured: At predefined intervals throughout the study completion, approximately 24 months.
To determine the PK of AC682 after a single dose or multiple doses:
Maximum plasma concentration (Cmax)
Measured: At predefined intervals throughout the study completion, approximately 24 months.
To determine the PK of AC682 after a single dose or multiple doses:
Time to maximum plasma concentration (tmax)
Measured: At predefined intervals throughout the study completion, approximately 24 months.
To determine the PK of AC682 after a single dose or multiple doses:
Terminal elimination half life (t1/2)
Measured: At predefined intervals throughout the study completion, approximately 24 months.
To evaluate the preliminary anti-tumor activity of AC682:
Objective Response Rate(ORR) using RECIST version 1.1
Measured: Throughout the study completion, approximately 24 months
To evaluate the preliminary anti-tumor activity of AC682:
Clinical Benefit Rate (CBR) using RECIST version 1.1
Measured: Throughout the study completion, approximately 24 months
To evaluate the preliminary anti-tumor activity of AC682:
Duration of Response (DoR) using RECIST version 1.1
Measured: Throughout the study completion, approximately 24 months
To evaluate the preliminary anti-tumor activity of AC682:
Disease Control Rate (DCR) using RECIST version 1.1
Measured: Throughout the study completion, approximately 24 months
To evaluate the preliminary anti-tumor activity of AC682:
Progression-free Survival (PFS) using RECIST version 1.1
Measured: Throughout the study completion, approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start1 Oct 2022
- Primary completion28 Sep 2023
- Study completion28 Sep 2023
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
- 6 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
- NCT05489679
- Sponsor's protocol ID
- AC682-002
- Status last verified
- Jan 2024
- First submitted
- 15 Jul 2022
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. 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 and Preliminary Anti-Tumor Activity of AC682 In Chinese Patients With ER+/HER2- Locally Advanced or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT05489679
- Acronym / sponsor ID
- AC682-002
- Conditions
- Breast Cancer
- Keywords
- Estrogen receptor positive, ER positive, ER+, Human epidermal growth factor receptor 2 negative, HER2 negative, AC682, Phase I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Voluntarily terminate the study since the sponsor's development strategy was adjusted.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Accutar Biotechnology IncIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 28 Sep 2023 (actual)
- Study completion
- 28 Sep 2023 (actual)
- First posted
- 5 Aug 2022 (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 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:
- To evaluate the safety and tolerability of AC682
- To evaluate the pharmacokinetic of AC682
- To evaluate the preliminary anti-tumor activity of AC682
Detailed description
This is a Phase I, 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. The participants will participate in this dose escalation arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must be ≥18 years-of-age at the time of signing of the ICF
- Histologically and/or cytologically confirmed advanced estrogen receptor positive (ER+) human epidermal growth factor 2 negative (HER2-) breast cancer
- Female patients must be postmenopausal
- At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 or at least 1 predominantly lytic bone lesion in the absence of measurable disease
- Previously received at least 1 endocrine therapy regimen; concomitant use of cyclin-dependent kinase (CDK) 4/6 inhibitor(s) is acceptable; Previous chemotherapy is not required, but up to 2 prior regimens of cytotoxic chemotherapy is allowed.
Key exclusion criteria (7 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)
- Received radiotherapy (including radioactive isotope therapy) within 4 weeks prior to the first dose of AC682
- Major surgery (excluding placement of vascular access) within 4 weeks of first dose of AC682
- With known metastasis to the brain
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) from AC682 monotherapy
Time frame: 28 days
Number of subjects with DLT
Incidence of treatment emergent adverse events(TEAEs) from AC682 monotherapy
Time frame: Throughout the study completion, approximately 24 months
Number of adverse events as characterized by type, frequency, seriousness, and relationship to AC682
10 secondary outcomes
To determine the PK of AC682 after a single dose or multiple doses:
Time frame: At predefined intervals throughout the study completion, approximately 24 months.
To determine the PK of AC682 after a single dose or multiple doses:
Time frame: At predefined intervals throughout the study completion, approximately 24 months.
To determine the PK of AC682 after a single dose or multiple doses:
Time frame: At predefined intervals throughout the study completion, approximately 24 months.
To determine the PK of AC682 after a single dose or multiple doses:
Time frame: At predefined intervals throughout the study completion, approximately 24 months.
To determine the PK of AC682 after a single dose or multiple doses:
Time frame: At predefined intervals throughout the study completion, approximately 24 months.
To evaluate the preliminary anti-tumor activity of AC682:
Time frame: Throughout the study completion, approximately 24 months
To evaluate the preliminary anti-tumor activity of AC682:
Time frame: Throughout the study completion, approximately 24 months
To evaluate the preliminary anti-tumor activity of AC682:
Time frame: Throughout the study completion, approximately 24 months
To evaluate the preliminary anti-tumor activity of AC682:
Time frame: Throughout the study completion, approximately 24 months
To evaluate the preliminary anti-tumor activity of AC682:
Time frame: Throughout the study completion, approximately 24 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 25 Jan 2024.
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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.
3 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 3 sites in China.
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 6 inclusion and 7 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 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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) from AC682 monotherapy (time frame: 28 days). 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 25 Jan 2024.