Study on VS-6766, Abemaciclib, and Fulvestrant for Advanced HR+/HER2- Breast Cancer

Sponsor: Adrienne G. Waks

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05608252

Provider View

This clinical trial is testing a new drug, VS-6766, in combination with abemaciclib and fulvestrant to see if it is safe and effective for treating advanced hormone receptor-positive, HER2-negative breast cancer.

Patient Parameters

Program Overview

The study aims to evaluate the safety and effectiveness of a new drug, VS-6766, when used with abemaciclib and fulvestrant in patients with advanced hormone receptor-positive, HER2-negative breast cancer. The trial is divided into three parts: screening, treatment, and follow-up. Participants will receive the treatment as long as it is safe and the cancer does not worsen. About 63 people are expected to participate. The study is supported by Verastem Oncology and Eli Lilly, who provide the drugs and funding.

Description

This trial is a Phase 1/2 study to test the safety and effectiveness of a new drug, VS-6766, combined with abemaciclib and fulvestrant for treating advanced hormone receptor-positive, HER2-negative breast cancer. VS-6766 is a new drug that targets cancer cell growth pathways, while abemaciclib and fulvestrant are already approved for breast cancer treatment. The study includes a screening period, a treatment period, and a follow-up period. Participants will continue treatment as long as it is safe and effective. The study involves about 63 participants and is supported by Verastem Oncology and Eli Lilly.

Eligibility Criteria

Inclusion Criteria

  • Have advanced hormone receptor-positive, HER2-negative breast cancer that cannot be removed by surgery.
  • Cancer must have progressed after treatment with a CDK 4/6 inhibitor or fulvestrant.
  • No more than two prior chemotherapy treatments for advanced cancer.
  • Willing to undergo tumor biopsies if required.
  • Good overall health with a performance status of less than 2.
  • Normal organ and blood function as determined by specific tests.
  • Age over 18 years.
  • Agree to use effective contraception during and after the study.
  • Able to swallow and retain oral medication.
  • Willing to sign informed consent.

Exclusion Criteria

  • Active brain metastases or cancer spread to the brain lining.
  • Stopped abemaciclib or fulvestrant due to side effects.
  • Previous treatment with a MEK inhibitor.
  • Recent participation in another clinical trial or treatment with investigational drugs.
  • Recent chemotherapy, immunotherapy, or radiation.
  • Major surgery within the last 14 days.
  • Certain eye conditions or history of muscle disorders.
  • Uncontrolled health conditions like heart disease or diabetes.
  • History of another cancer unless disease-free for 5 years.
  • Allergic reactions to study drugs.
  • Active infections like HIV, hepatitis B, or C.
  • Pregnant or breastfeeding women.
  • Unable to swallow pills or have digestive issues affecting medication absorption.
  • Active bacterial or fungal infections requiring IV treatment.
  • On warfarin treatment without switching to another anticoagulant.

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