Status:
ACTIVE_NOT_RECRUITING
CFI-402257, a Potent and Selective TTK Inhibitor, in Solid Tumors and With Fulvestrant in Breast Cancer
Lead Sponsor:
Treadwell Therapeutics, Inc
Conditions:
Advanced Solid Tumor
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to test the safety of an investigational drug called CFI-402257 alone in advanced solid tumors and in combination with Fulvestrant in advanced breast cancer patients.
Detailed Description
This study will be evaluating the safety and tolerability of CFI-402257 in subjects with advanced solid tumors and in advanced breast cancer. The study is designed to build on encouraging data from an...
Eligibility Criteria
Inclusion
- Part A Escalation
- 1\. Have histological or cytological proof of advanced cancer that has progressed on at least 1 prior line of systemic therapy
- Part A Expansion
- Breast cancer patients positive for estrogen receptor and/or progesterone receptor and negative for HER2
- Must have previously received a CDK4/6 inhibitor
- No limit on lines of endocrine therapy
- Must have received no more than 1 line of cytotoxic chemotherapy
- Have measurable disease as per RECIST 1.1 guidelines.
- Part B
- Breast cancer patients positive for estrogen receptor and/or progesterone receptor and negative for HER2
- Must have previously received a CDK4/6 inhibitor
- Must have previously received no more than 1 line of endocrine therapy
- Must have received no more than 1 line of cytotoxic chemotherapy
- Have measurable disease as per RECIST 1.1 guidelines.
Exclusion
- All Parts
- Are pregnant or nursing.
- Have received chemotherapy, biological therapy, or investigational treatment less than 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to first dose of study drug. Have received radiotherapy less than 2 weeks prior to first dose of study drug.
- Received growth factors within 14 days prior to initiation of dosing of CFI-402257 or who will require ongoing treatment with growth factors
- Have active, acute, or clinically significant chronic infections.
- Have the following cardiovascular conditions
- Have uncontrolled severe hypertension
- Have symptomatic congestive heart failure
- Have active angina pectoris or recent myocardial infarction
- Have chronic atrial fibrillation or QTc of greater than 470 msec.
- Have had major surgery within 21 days of starting therapy.
- Primary central nervous system malignancies or known central nervous system metastasis.
- Being treated with full dose warfarin.
- Coagulopathy or any history of coagulopathy within the past 6 months, including history of deep vein thrombosis or pulmonary embolism.
- Patients must avoid the use of strong CYP3A4 inducers and inhibitors. CYP3A sensitive substrates, PgP, BCRP inhibitors
- Have had prior treatment with a TTK/MPS1 inhibitor.
- Part B only: Known bleeding disorder which would prohibit administration of fulvestrant.
- Part B only: Concomitant active malignancy other than ER+/HER2- advanced breast cancer.
- Part A only: Concomitant active malignancy other than primary malignancy
- Part B only: Had prior treatment with fulvestrant or agents with similar MoA
Key Trial Info
Start Date :
May 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT05251714
Start Date
May 27 2022
End Date
August 1 2026
Last Update
May 18 2025
Active Locations (4)
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1
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
2
START San Antonio
San Antonio, Texas, United States, 78229
3
START - Mountain Region
West Valley City, Utah, United States, 84119
4
Virginia Cancer Specialist
Fairfax, Virginia, United States, 22031