CFI-402257, a Potent and Selective TTK Inhibitor, in Solid Tumors and With Fulvestrant in Breast Cancer

NCT ID: NCT05251714

Last Updated: 2025-05-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-27
• Study Completion Date: 2026-08-31

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 another study and to obtain further safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) data of CFI-402257.

Conditions

Advanced Solid Tumor; Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part A: Monotherapy Escalation and Expansion

Dose selection and expansion of CFI-402257

Group Type: EXPERIMENTAL

CFI-402257

Intervention Type: DRUG

Oral once daily in 28 day cycles

Part B: Combination Escalation and Expansion

Dose selection and expansion of CFI-402257 with Fulvestrant

Group Type: EXPERIMENTAL

CFI-402257

Intervention Type: DRUG

Oral once daily in 28 day cycles

Fulvestrant

Intervention Type: DRUG

500 mg given by IM injection on Day 1 and Day 15 of Cycle 1 and Day 1 of each subsequent cycle

Interventions

CFI-402257

Oral once daily in 28 day cycles

Intervention Type: DRUG

Fulvestrant

500 mg given by IM injection on Day 1 and Day 15 of Cycle 1 and Day 1 of each subsequent cycle

Intervention Type: DRUG

Other Intervention Names

2257; 402257; Faslodex

Eligibility Criteria

Inclusion Criteria

1. Have histological or cytological proof of advanced cancer that has progressed on at least 1 prior line of systemic therapy

1. Breast cancer patients positive for estrogen receptor and/or progesterone receptor and negative for HER2

2. Must have previously received a CDK4/6 inhibitor

3. No limit on lines of endocrine therapy

4. Must have received no more than 1 line of cytotoxic chemotherapy

5. Have measurable disease as per RECIST 1.1 guidelines.

1. Breast cancer patients positive for estrogen receptor and/or progesterone receptor and negative for HER2

2. Must have previously received a CDK4/6 inhibitor

3. Must have previously received no more than 1 line of endocrine therapy

4. Must have received no more than 1 line of cytotoxic chemotherapy

5. Have measurable disease as per RECIST 1.1 guidelines.

Exclusion Criteria

1. Are pregnant or nursing.

2. 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.

3. Received growth factors within 14 days prior to initiation of dosing of CFI-402257 or who will require ongoing treatment with growth factors

4. Have active, acute, or clinically significant chronic infections.

5. 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.

6. Have had major surgery within 21 days of starting therapy.

7. Primary central nervous system malignancies or known central nervous system metastasis.

8. Being treated with full dose warfarin.

9. Coagulopathy or any history of coagulopathy within the past 6 months, including history of deep vein thrombosis or pulmonary embolism.

10. Patients must avoid the use of strong CYP3A4 inducers and inhibitors. CYP3A sensitive substrates, PgP, BCRP inhibitors

11. Have had prior treatment with a TTK/MPS1 inhibitor.

12. Part B only: Known bleeding disorder which would prohibit administration of fulvestrant.

13. Part B only: Concomitant active malignancy other than ER+/HER2- advanced breast cancer.

14. Part A only: Concomitant active malignancy other than primary malignancy

15. Part B only: Had prior treatment with fulvestrant or agents with similar MoA

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Treadwell Therapeutics, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

R Wesolowski

Role: PRINCIPAL_INVESTIGATOR

The Ohio State University Comprehensive Cancer Center

Locations

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

START San Antonio

San Antonio, Texas, United States

START - Mountain Region

West Valley City, Utah, United States

Virginia Cancer Specialist

Fairfax, Virginia, United States

Countries

United States

Other Identifiers

TWT-203

Identifier Type: -

Identifier Source: org_study_id