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

Kind Pharmaceuticals LLC1 site in 1 country61 target enrollmentOctober 5, 2022

ConditionsAdvanced or Metastatic Breast Cancer

InterventionsAND019 PO QD

DrugsAND019 PO QD

Overview

Phase: Phase 1
Intervention: AND019 PO QD
Conditions: Advanced or Metastatic Breast Cancer
Sponsor: Kind Pharmaceuticals LLC
Enrollment: 61
Locations: 1
Primary Endpoint: PK study of AND019
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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 receptor 2 [HER2]-negative) breast cancer.

Registry

clinicaltrials.gov

Start Date

October 5, 2022

End Date

May 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Sequential

Sex

Female

Investigators

Sponsor

Kind Pharmaceuticals LLC

Responsible Party

Sponsor

Eligibility Criteria

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-
•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.

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.

Arms & Interventions

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

Intervention: AND019 PO QD

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

Percentage of Participants with Objective Response(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))
Duration of 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))
Determine the RP2D(From baseline to up to the end of Cycle 1 (each cycle is 28 days))
Clinical Benefit Rate(Baseline and every 8 weeks from Cycle 1 Day 1 until Week 24 (each cycle is 28 days))