Advanced or Metastatic Breast CancerPhase 1NCT05187832
A Study of AND019 in Women With ER Positive HER2 Negative Advanced or Metastatic Breast Cancer
A Phase 1 study testing AND019 PO QD in people with Advanced or Metastatic Breast Cancer, run by Kind Pharmaceuticals LLC at 1 site in United States.
Trial summary
This is a first in human dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) activity, and preliminary anti-tumor activity of AND019 in postmenopausal women with advanced or metastatic estrogen receptor (ER)-positive (human epidermal growth factor… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Advanced or Metastatic Breast Cancer
- What is being tested?
- AND019 PO QD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2022to Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Postmenopausal women defined as NCCN guideline at the time of informed consent.
- Histological or cytological confirmation of advanced or metastatic ER+/HER2- breast cancer women who failed standard therapy or for which no standard therapy exists.
- Prior therapy:
- No more than 1 line of chemotherapy for advanced breast cancer
- Recurrence or progression on at least one line of endocrine therapy in the advanced or metastatic disease setting and derived a clinical benefit from the endocrine therapy: Recurred or progressed while being treated with adjuvant endocrine therapy for a duration of at least 24 months, or progressed under endocrine therapy for more than 6 months in the advanced or metastatic setting
- ECOG score 0-1.
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- Minimum life expectancy of a least 3 months as determined by the Investigator.
- Evaluable disease per RECIST 1.1; for patients consent to tissue biopsy, disease suitable for tumor biopsy.
- Sufficient bone marrow reserve and organ function.
Who cannot join
- Previous treatment with any SERDs.
- Patient any central nervous system metastasis.
- Prior antitumor therapies:
- Received chemotherapies within 3 weeks before the first dose.
- Received systemic radiotherapy within 3 weeks before the first dose, or local radiotherapy within 7 days before the first dose
- Received other anti-tumor therapy such as endocrine therapy, immunotherapy, and target therapy within 3 weeks or 5 half-lives of the drug before the first dose of the study drug
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- For bone metastasis, bisphosphonates and local remission therapy are allowed (7 days washout for local radiation therapy).
- Patient who has participated in any other clinical trials for drugs or treatments within 5 half-lives for a prior investigational drug or 2 weeks from use of an investigational device prior to the first dose of study drug.
- Patient who had major surgery or significant trauma within 4 weeks prior to the first dose of study drug (excluding needle biopsy), or has scheduled surgery during the study period.
- Patient with serous unhealable wounds/ulcers/fractures within 4 weeks prior to the first dose of study drug.
- Patient with adverse reactions to previous anti-tumor treatments who have not yet recovered to grade ≤1 according to CTCAE v5.0. (except for toxicities without safety risks as judged by Investigator, such as alopecia, grade 2 peripheral neuropathy etc.)
- Patient who has used strong inhibitors or strong inducers of CYP3A, or grapefruit or grapefruit juice within 4 weeks prior to the first dose of study drug.
- Patient unable to be administered oral medications or any condition that seriously affect digestion in the gastrointestinal tract at the judgement of the Investigator.
- Patient with active infection within 1 week prior to the first dose of study drug, and currently need systemic anti-infective treatment.
- Patient has a known history of the following: HIV infection without effective antiretroviral therapy (ART) or acceptable immune function, or syphilis infection, or HBsAg positive HBV or needs prophylaxis therapy or suppressive antiviral therapy before dosing, or has an HCV infection that hasn't completed curative antiviral treatment or with unacceptable viral load.
- Patient has active cardiac disease or a history cardiac dysfunction.
- Patient with third spacing that cannot be controlled clinically and is not suitable for the study by the Investigator's judgment.
- Patient with known history of drug abuse.
- Patient with mental disorder that, in the opinion of the Investigator, could lead to poor compliance with required study procedures.
- Patient that cannot tolerate venous blood sampling.
- Known to have other malignancy within the past 5 years, and is progressing or requires active treatment (except skin basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma in situ who have received potentially radical treatment)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
About this study
Official title: A Phase I Dose Escalation and Dose Expansion Study of AND019 in Patients With Estrogen Receptor Positive Human Epidermal Growth Factor Receptor 2 Negative Advanced or Metastatic Breast Cancer
This is a first in human dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) activity, and preliminary anti-tumor activity of AND019 in postmenopausal women with advanced or metastatic estrogen receptor (ER)-positive (human epidermal growth factor receptor 2 [HER2]-negative) breast cancer.
- Conditions
- Advanced or Metastatic Breast Cancer
- Being tested
- AND019 PO QD
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AND019 PO QDDrug
AND019 administrated as oral capsule once per day for 28 days for each cycle
| Study group | Role | What they receive |
|---|---|---|
| AND019 single dose escalation and expansion | Experimental | Subjects will be administrated with AND019 capsule PO QD from 20 mg to 400 mg during Part 1, and 2 dose groups will be selected for dose expansion study Receives: Drug: AND019 PO QD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events by severity, according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0
Number of participants with adverse events
Measured: From baseline to 12 weeks after the last dose of study treatment (up to 25 months)
PK study of AND019
Plasma concentration of AND019 over time
Measured: At predefined timepoints at Day 1, Day 8, Day 15, and Day 22 of Cycle 1, and Day 1 of each cycle starting from Cycle 2 (each cycle is 28 days)
Secondary outcomes (4)
Determine the RP2D
To observe the dose limiting toxicity (DLT) and maximum tolerated dose MTD to determine RP2D.
Measured: From baseline to up to the end of Cycle 1 (each cycle is 28 days)
Percentage of Participants with Objective Response
ORR is defined as a complete response or partial response on two consecutive occasions ≥4 weeks apart, as determined by the investigator according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1)
Measured: Baseline and every 8 weeks from Cycle 1 Day 1 until Week 24, and then every 12 weeks until end of study treatment (up to 24 months) (each cycle is 28 days)
Clinical Benefit Rate
CBR is defined as the percentage of participants achieving either of the following: confirmed complete response or partial response (as determined by the investigator according to RECIST v1.1); or the first occurrence of progressive disease after 24 weeks of study treatment.
Measured: Baseline and every 8 weeks from Cycle 1 Day 1 until Week 24 (each cycle is 28 days)
Duration of Response
DoR is defined as the percentage of participants achieving either of the following: confirmed complete response or partial response.
Measured: From the first occurrence of a documented objective response until first observation of disease progression or death from any cause on study, whichever occurs first (up to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start5 Oct 2022
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kind Pharmaceuticals LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yusha Zhu, MD PhD, Study director, Kind Pharmaceuticals LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187832
- Sponsor's protocol ID
- AND019-MN-101
- Status last verified
- Feb 2026
- First submitted
- 10 Dec 2021
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalation and Dose Expansion Study of AND019 in Patients With Estrogen Receptor Positive Human Epidermal Growth Factor Receptor 2 Negative Advanced or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT05187832
- Acronym / sponsor ID
- AND019-MN-101
- Conditions
- Advanced or Metastatic Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- Kind Pharmaceuticals LLCIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 12 Jan 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 is a first in human dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) activity, and preliminary anti-tumor activity of AND019 in postmenopausal women with advanced or metastatic estrogen receptor (ER)-positive (human epidermal growth factor receptor 2 [HER2]-negative) breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AND019 single dose escalation and expansion | Experimental | Drug: AND019 PO QDSubjects will be administrated with AND019 capsule PO QD from 20 mg to 400 mg during Part 1, and 2 dose groups will be selected for dose expansion study |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Postmenopausal women defined as NCCN guideline at the time of informed consent.
- Histological or cytological confirmation of advanced or metastatic ER+/HER2- breast cancer women who failed standard therapy or for which no standard therapy exists.
- Prior therapy:
- ECOG score 0-1.
- Minimum life expectancy of a least 3 months as determined by the Investigator.
Key exclusion criteria (21 listed)
- Previous treatment with any SERDs.
- Patient any central nervous system metastasis.
- Prior antitumor therapies:
- Patient who has participated in any other clinical trials for drugs or treatments within 5 half-lives for a prior investigational drug or 2 weeks from use of an investigational device prior to the first dose of study drug.
- Patient who had major surgery or significant trauma within 4 weeks prior to the first dose of study drug (excluding needle biopsy), or has scheduled surgery during the study period.
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 |
|---|---|---|
| AND019 PO QDAND019 administrated as oral capsule once per day for 28 days for each cycle | Drug | AND019 single dose escalation and expansion |
Primary outcome
Number of participants with adverse events by severity, according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0
Time frame: From baseline to 12 weeks after the last dose of study treatment (up to 25 months)
Number of participants with adverse events
PK study of AND019
Time frame: At predefined timepoints at Day 1, Day 8, Day 15, and Day 22 of Cycle 1, and Day 1 of each cycle starting from Cycle 2 (each cycle is 28 days)
Plasma concentration of AND019 over time
4 secondary outcomes
Determine the RP2D
Time frame: From baseline to up to the end of Cycle 1 (each cycle is 28 days)
Percentage of Participants with Objective Response
Time frame: Baseline and every 8 weeks from Cycle 1 Day 1 until Week 24, and then every 12 weeks until end of study treatment (up to 24 months) (each cycle is 28 days)
Clinical Benefit Rate
Time frame: Baseline and every 8 weeks from Cycle 1 Day 1 until Week 24 (each cycle is 28 days)
Duration of Response
Time frame: From the first occurrence of a documented objective response until first observation of disease progression or death from any cause on study, whichever occurs first (up to 24 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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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.
Yusha Zhu, MD PhD study director
Kind Pharmaceuticals LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AND019 PO QD in people with Advanced or Metastatic Breast Cancer, run by Kind Pharmaceuticals LLC at 1 site 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 9 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yusha Zhu, MD PhD (6467252552, yushazhu@kindpharmaceutical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events by severity, according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 (time frame: From baseline to 12 weeks after the last dose of study treatment (up to 25 months)). 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 27 Feb 2026.