Moffitt Cancer Center: Clinical Trial 20171

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Clinical Trial 20171

Cancer Type: Breast
Interventions:ARV-471

Study Type: Treatment
Phase of Study: Phase I
Investigators:

Heather Han

Call 813-745-6100
or 1-800-679-0775

Overview

Study Title

A Phase 1, Open-label, Dose Escalation Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of ARV-471 in Patients with ER+/HER2- Locally Advanced or Metastatic Breast Cancer, Who Have Received Prior Hormonal Therapy and Chemotherapy in the Locally Advanced/Metastatic Setting

Summary

This is a first in human, dose escalation study and will assess the safety and tolerability of ARV-471 in woman and men with ER+/HER2- locally advanced or metastatic breast cancer, who have received prior hormonal therapy and chemotherapy in the locally advanced/metastatic setting.

Objective

Primary: To evaluate the safety and tolerability of ARV-471in successive cohorts of patients in order to estimate the maximum tolerated dose and select the recommended phase 2 dose/schedule. Secondary: To characterize the single dose and steady-state PK of ARV-471 and ARV-473 (an epimer of ARV-471). To explore preliminary anti-tumor activity.

Inclusion Criteria

Participants at least 18 years of age at the time of signing the informed consent.

Participants must have histologically or cytologically confirmed ER+ and HER2- advanced breast cancer. Advanced breast cancer is metastatic, recurrent, or locally advanced unresectable breast cancer for which standard curative therapy is no longer effective or does not exist.

Participants must have measurable or non-measurable disease by RECIST criteria (version1.1), with radiologic tumor assessments performed within 28 days of the first dose of therapy.

Participants must have received at least 2 prior endocrine regimens in any setting (neoadjuvant, adjuvant or advanced/metastatic) a CDK4/6 inhibitor and up to 3 prior regimens of cytotoxic chemotherapy in the locally advanced or metastatic setting. All such therapy must be discontinued at least 14 days prior to enrollment.

Participants must be willing to undergo a biopsy of accessible tumor within 4 weeks prior to the initiation of study treatment and a follow-up biopsy on treatment for ER IHC testing and PD studies. (Participants without accessible tumor tissue may be eligible after discussion with the Medical Monitor.)

Exclusion Criteria

Participants with known symptomatic brain metastases requiring steroids (above physiologic replacement doses). Participants with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to first dose of study drug, have discontinued high-dose corticosteroid treatment for these metastases for at least 4 weeks and are neurologically stable as judged by the Investigator.

Participants who have received 4 or more regimens of chemotherapy for locally advanced or mBC.

Receipt of prior anti-cancer or other investigational therapy within 14 days prior to the first administration of study drug.

Radiation therapy within 4 weeks of first dose of study drug or prior irradiation to >25% of the bone marrow. Palliative radiation for the alleviation of pain due to bone metastasis will be allowed during the study.