Study on CFI-402257, a New Drug for Solid Tumors and Breast Cancer with Fulvestrant

Sponsor: Treadwell Therapeutics, Inc

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05251714

Provider View

This clinical trial is testing the safety of a new drug called CFI-402257, both on its own for advanced solid tumors and in combination with Fulvestrant for advanced breast cancer.

Patient Parameters

Program Overview

The aim of this study is to evaluate how safe and tolerable the investigational drug CFI-402257 is for patients with advanced solid tumors and advanced breast cancer. Researchers are building on previous promising results to gather more information on the drug's safety, effectiveness, and how it behaves in the body.

Description

This study is focused on understanding the safety and effects of a new drug, CFI-402257, in patients with advanced solid tumors and breast cancer. The research will look at how the drug works alone and when combined with Fulvestrant, a medication used in breast cancer treatment. The study will collect data on how the drug is processed in the body and its impact on the cancer.

Eligibility Criteria

Inclusion Criteria

  • For Part A: Must have advanced cancer that has worsened after at least one previous treatment.
  • For Part A Expansion: Must have breast cancer that is positive for estrogen or progesterone receptors and negative for HER2. Must have previously taken a CDK4/6 inhibitor and can have had any number of hormone therapies but only one chemotherapy treatment. Must have measurable cancer.
  • For Part B: Must have breast cancer that is positive for estrogen or progesterone receptors and negative for HER2. Must have previously taken a CDK4/6 inhibitor and only one hormone therapy and one chemotherapy treatment. Must have measurable cancer.

Exclusion Criteria

  • Cannot be pregnant or breastfeeding.
  • Cannot have had chemotherapy, biological therapy, or experimental treatment within 4 weeks (or 6 weeks for certain drugs) before starting the study drug. Cannot have had radiation therapy within 2 weeks before starting the study drug.
  • Cannot have used growth factors within 14 days before starting the study drug or need ongoing growth factor treatment.
  • Cannot have active or serious infections.
  • Cannot have certain heart conditions, such as uncontrolled high blood pressure, heart failure, chest pain, recent heart attack, or irregular heartbeats.
  • Cannot have had major surgery within 21 days before starting the study.
  • Cannot have cancer in the brain or known brain metastasis.
  • Cannot be on full dose warfarin.
  • Cannot have blood clotting disorders or history of blood clots in the past 6 months.
  • Must avoid certain medications that affect how the body processes drugs.
  • Cannot have had previous treatment with a TTK/MPS1 inhibitor.
  • For Part B only: Cannot have a bleeding disorder that would prevent taking Fulvestrant.
  • For Part B only: Cannot have another active cancer besides ER+/HER2- advanced breast cancer.
  • For Part A only: Cannot have another active cancer besides the primary cancer being studied.
  • For Part B only: Cannot have had previous treatment with Fulvestrant or similar drugs.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.