A Study of AND019 in Women With ER Positive HER2 Negative Advanced or Metastatic Breast Cancer

Conditions

• Advanced or Metastatic Breast Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• AND019 PO QD — DRUG
  AND019 administrated as oral capsule once per day for 28 days for each cycle

Study Details

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.

Key Dates

Start date

Oct 5, 2022

Status verified

Feb 2026

Primary completion

Nov 30, 2026

Completion

Nov 30, 2026

Study Design

Enrollment

61 participants (estimated)

Allocation

NA

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• 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

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) ]

Central Contacts

• Yusha Zhu, MD PhD
  6467252552
  [email protected]

Locations (1)

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