AND019 for Breast Cancer

Overseen By Yusha Zhu, MD PhD

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Kind Pharmaceuticals LLC

Must not be taking: SERDs, CYP3A inhibitors

Disqualifiers: CNS metastasis, Active cardiac disease, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

61 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, AND019, for safety and effectiveness in treating advanced breast cancer that is estrogen receptor-positive and HER2-negative. It targets postmenopausal women whose cancer has returned or worsened after standard treatments. The trial involves administering different doses of AND019 to determine the safest and most effective amount. Women who have not found success with other treatments for this type of breast cancer might be suitable candidates. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Do I need to stop my current medications for the trial?

The trial requires that you stop certain medications before starting. You must not have received chemotherapy, systemic radiotherapy, or other anti-tumor therapies like endocrine therapy within 3 weeks before the first dose. Additionally, you should not have used strong inhibitors or inducers of CYP3A, or consumed grapefruit or grapefruit juice within 4 weeks prior to the first dose.

Is there any evidence suggesting that AND019 is likely to be safe for humans?

Research shows that AND019 is being tested for safety and tolerability in postmenopausal women with a specific type of advanced breast cancer. This marks the first human trial of AND019, so no previous safety data from human studies exists. This initial phase aims to find a safe dose and identify any side effects.

Participants in this study will receive varying doses of AND019 to assess their responses. The goal is to determine which dose is safe and which might cause unwanted effects. As a new treatment, specific safety data from earlier studies is not yet available. However, this early phase helps researchers begin to understand the drug's effects and safety in humans.

As the study progresses, more information on safety and tolerability will emerge. Participants will be closely monitored for any side effects or adverse reactions during this process. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike traditional treatments for breast cancer, which often involve chemotherapy, hormone therapy, or targeted therapies like HER2 inhibitors, AND019 works by a novel mechanism that is still being explored. Researchers are excited about AND019 because it offers a potentially new approach to targeting breast cancer cells, which could lead to different or improved outcomes. Moreover, the treatment is administered orally in capsule form, which could make it more convenient for patients compared to some current treatments requiring intravenous administration. This unique delivery method and mechanism of action have the potential to offer new hope in breast cancer care.

What evidence suggests that AND019 might be an effective treatment for breast cancer?

Research shows that AND019 is being developed as a potential new treatment for advanced breast cancer that is ER-positive and HER2-negative. This drug breaks down estrogen receptors, which can slow or stop the growth of cancer cells that rely on estrogen. Early results suggest that drugs like AND019, known as oral SERDs (Selective Estrogen Receptor Degraders), hold promise for treating this type of breast cancer. Although limited information exists on AND019 in humans, studies on similar treatments have improved patient outcomes. As research progresses, scientists aim to confirm the effectiveness of AND019 in managing this condition. ^{1 2 3 4 5}

Who Is on the Research Team?

Yusha Zhu, MD PhD

Principal Investigator

Kind Pharmaceuticals LLC

Are You a Good Fit for This Trial?

This trial is for postmenopausal women with advanced or metastatic ER+/HER2- breast cancer who have failed standard therapy or have no standard options left. They should be relatively healthy (ECOG score 0-1), have a life expectancy of at least 3 months, and must not have had more than one chemotherapy for advanced breast cancer.

Inclusion Criteria

My cancer can be measured by scans and is suitable for a biopsy.

My bone marrow and organs are functioning well.

My breast cancer is ER+ and HER2-, and standard treatments haven't worked.

Exclusion Criteria

I have been treated with SERDs before.

Patient with third spacing that cannot be controlled clinically and is not suitable for the study by the Investigator's judgment

I haven't had major surgery or significant injury in the last 4 weeks and have no planned surgeries.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of AND019 to determine the maximum tolerated dose

4-8 weeks

Weekly visits for dose adjustments and monitoring

Dose Expansion

Participants receive selected doses of AND019 to further evaluate safety and efficacy

24 weeks

Visits every 4 weeks for assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AND019

Trial Overview AND019 PO QD is being tested to see how safe it is, how the body processes it, and if it works against certain types of breast cancer. This study includes increasing doses to find the right amount and will also look at its effects on tumor activity in participants.

How Is the Trial Designed?

Group I: AND019 single dose escalation and expansion Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Kind Pharmaceuticals LLC

Lead Sponsor

Trials

9

Recruited

640+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05187832

A Study of AND019 in Women With ER Positive HER2 ... This is a first in human dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) activity, ...

2. cancertherapyadvisor.com cancertherapyadvisor.com/news/and019-advanced-er-her2-breast-cancer-clinical-trial/

Clinical Trial: AND019 in Advanced ER+, HER2- Breast ... The primary outcomes are the number of participants with adverse events and the pharmacokinetics of AND019. Secondary outcomes include the ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0305737224001531

Oral SERDs changing the scenery in hormone receptor ... However, while these endocrine therapies significantly improved outcomes of hormone receptor positive breast cancer in the last decades, both primary and ...

4. withpower.com withpower.com/trial/phase-1-breast-neoplasms-2-2022-8d616

AND019 for Breast Cancer This trial is testing a new drug called AND019 to see if it is safe and effective for postmenopausal women with a specific type of advanced breast cancer.

5. synapse.patsnap.com synapse.patsnap.com/drug/fc83395f3d5c44a18de44ef13dc4fe4d

AND019 - Drug Targets, Indications, Patents AND019: a ERs degraders Drug, Initially developed by Hangzhou Kind Pharmaceuticals Co., Ltd., Now, its global highest R&D status is Phase 1, Mechanism: ERs ...