AND019 for Breast Cancer

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Kind Pharmaceuticals LLC

Must not be taking: SERDs, CYP3A inhibitors

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

No Placebo Group

Trial Summary

What is the purpose of this trial?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. The study will look at how the drug moves through the body and its effects on cancer cells.

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.

Eligibility Criteria

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.

+5 more

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.

+16 more

Trial Timeline

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

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: AND019 single dose escalation and expansionExperimental Treatment1 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