- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05187832
A Study of AND019 in Women With ER Positive HER2 Negative Advanced or Metastatic Breast Cancer
February 28, 2024 updated by: Kind Pharmaceuticals LLC
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
61
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yusha Zhu, MD PhD
- Phone Number: 6467252552
- Email: yushazhu@kindpharmaceutical.com
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37203
- Recruiting
- Sarah Cannon Research Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Key Inclusion Criteria:
- 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.
- 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.
Key Exclusion Criteria:
- 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
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AND019 single dose escalation and expansion
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
|
AND019 administrated as oral capsule once per day for 28 days for each cycle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
From baseline to 12 weeks after the last dose of study treatment (up to 25 months)
|
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine the RP2D
Time Frame: From baseline to up to the end of Cycle 1 (each cycle is 28 days)
|
To observe the dose limiting toxicity (DLT) and maximum tolerated dose MTD to determine RP2D.
|
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)
|
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)
|
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)
|
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.
|
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)
|
DoR is defined as the percentage of participants achieving either of the following: confirmed complete response or partial response.
|
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)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival
Time Frame: From treatment start date until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
|
PFS is defined as the time from treatment start date until objective tumor progression (PD) or death whichever comes first
|
From treatment start date until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
|
PD study of AND019 in blood samples
Time Frame: At predefined timepoints at baseline, Cycle 1 Day 15, Cycle 2 Day 1, and End of Treatment (up to 2 years) (each cycle is 28 days).
|
Change from baseline in therapy resistant markers by liquid biopsy
|
At predefined timepoints at baseline, Cycle 1 Day 15, Cycle 2 Day 1, and End of Treatment (up to 2 years) (each cycle is 28 days).
|
PD study of AND019 in tissue samples
Time Frame: At predefined timepoints at baseline and between Cycle 2 Day 1 to Cycle 3 Day 28 (each cycle is 28 days)
|
Change from baseline in therapy resistant markers by tissue biopsy
|
At predefined timepoints at baseline and between Cycle 2 Day 1 to Cycle 3 Day 28 (each cycle is 28 days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Yusha Zhu, MD PhD, Kind Pharmaceuticals LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 5, 2022
Primary Completion (Estimated)
May 1, 2026
Study Completion (Estimated)
May 1, 2026
Study Registration Dates
First Submitted
December 10, 2021
First Submitted That Met QC Criteria
December 24, 2021
First Posted (Actual)
January 12, 2022
Study Record Updates
Last Update Posted (Actual)
February 29, 2024
Last Update Submitted That Met QC Criteria
February 28, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AND019-MN-101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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