Clinical Trials /

Clinical Trial of ARV-471 in Patients With ER+/HER2- Locally Advanced or Metastatic Breast Cancer

NCT04072952

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Clinical Trial of ARV-471 in Patients With ER+/HER2- Locally Advanced or Metastatic Breast Cancer
  • Official Title: A Phase 1, Open-label, Dose Escalation Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of ARV-471 in Patients With Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Locally Advanced or Metastatic Breast Cancer, Who Have Received Prior Hormonal Therapy and Chemotherapy in the Locally Advanced/Metastatic Setting

Clinical Trial IDs

  • ORG STUDY ID: ARV-471-mBC-101
  • NCT ID: NCT04072952

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
ARV-471ARV-471

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
ARV-471Experimental
  • ARV-471

Eligibility Criteria

        Inclusion Criteria:

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

          -  Patients 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.

          -  Patients 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.

          -  Patients 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.

          -  Patients 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. (Patients without accessible tumor tissue may be eligible
             after discussion with the Medical Monitor.)

        Exclusion Criteria:

          -  Patients with known symptomatic brain metastases requiring steroids (above physiologic
             replacement doses). Patients 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.

          -  Patients 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of Dose Limiting Toxicities of ARV-471
Time Frame:28 Days
Safety Issue:
Description:First Cycle Dose limiting toxicities characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drug

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Arvinas Inc

Trial Keywords

  • Breast Cancer
  • Metastatic Breast Cancer
  • Malignant Neoplasm of the Breast
  • mBC
  • ER+/HER2-
  • Locally Advanced Breast Cancer

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