Advanced Solid TumorPhase 1/2NCT05251714
CFI-402257, a Potent and Selective TTK Inhibitor, in Solid Tumors and With Fulvestrant in Breast Cancer
A Phase 1/2 study testing CFI-402257 and Fulvestrant in people with Advanced Solid Tumor and Breast Cancer, run by Treadwell Therapeutics, Inc at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Breast Cancer
- What is being tested?
- CFI-402257 and Fulvestrant
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 4 sitesUnited States
- Study dates
- 27 May 2022to Aug 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Have histological or cytological proof of advanced cancer that has progressed on at least 1 prior line of systemic therapy
- 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.
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Virginia Cancer Specialist
Fairfax, Virginia, 22031
START San Antonio
San Antonio, Texas, 78229
START - Mountain Region
West Valley City, Utah, 84119
About this study
Official title: A Dose-confirming Study of CFI-402257 as a Single Agent in Advanced Solid Tumors and in Combination With Fulvestrant in Patients With ER+/HER2- Advanced Breast Cancer After Disease Progression on Prior CDK4/6 and Endocrine Therapy
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.
Read the 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
- Being tested
- CFI-402257, Fulvestrant
- Keywords
- advanced solid tumors, advanced breast cancer, CFI-402257, 2257, fulvestrant, TWT-203, TWT203, UHN, University Health Network, Treadwell, Treadwell Therapeutics, endocrine therapy, TTK, TTK inhibitor
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CFI-402257Drug
Also called 2257, 402257
Oral once daily in 28 day cycles
FulvestrantDrug
Also called Faslodex
500 mg given by IM injection on Day 1 and Day 15 of Cycle 1 and Day 1 of each subsequent cycle
| Study group | Role | What they receive |
|---|---|---|
| Part A: Monotherapy Escalation and Expansion | Experimental | Dose selection and expansion of CFI-402257 Receives: Drug: CFI-402257 |
| Part B: Combination Escalation and Expansion | Experimental | Dose selection and expansion of CFI-402257 with Fulvestrant Receives: Drug: CFI-402257; Drug: Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the incidence of adverse events of CFI-402257 as a single agent and at the recommended phase 2 dose (RP2D)
The number of subjects who experience an adverse event that was possibly related to study drug as assessed by CTCAE v 5.0.
Measured: 48 months
To assess the incidence of adverse events of CFI-402257 in combination with fulvestrant and at the recommended phase 2 dose (RP2D)
The number of subjects who experience an adverse event that was possibly related to study drug as assessed by CTCAE v 5.0.
Measured: 48 months
Secondary outcomes (5)
Assessment of objective response rates
Objective response rate will be summarized by dose cohort and overall using the percent of patients in each tumor response category.
Measured: 48 months
Assessment of objective response rates of the combination
Objective response rate will be summarized overall for advanced breast cancer patients
Measured: 48 months
Assessment of the pharmacokinetic profile of CFI-402257 through AUC
Area under the plasma concentration (AUC) versus time curve from time 0 to time of least measurable concentration tabulated by dose group.
Measured: 48 months
Assessment of the pharmacokinetic profile of CFI-402257 in combination with fulvestrant through AUC
Area under the plasma concentration (AUC) versus time curve from time 0 to time of least measurable concentration tabulated by dose group.
Measured: 48 months
To evaluate the effect of CFI-402257 treatment on changes in variant allele function
Changes in variant allele function will be measured by looking at circulating tumor deoxyribonucleic acid compared to baseline
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start27 May 2022
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Dose escalation and expansion for monotherapy and combination arms with fulvestrant
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Treadwell Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- R Wesolowski, Principal investigator, The Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251714
- Sponsor's protocol ID
- TWT-203
- Status last verified
- May 2025
- First submitted
- 7 Feb 2022
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: It is too early to determine whether we will make IPD available - we do not yet have a process written on this. Field will be updated once our policy / process is written.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-confirming Study of CFI-402257 as a Single Agent in Advanced Solid Tumors and in Combination With Fulvestrant in Patients With ER+/HER2- Advanced Breast Cancer After Disease Progression on Prior CDK4/6 and Endocrine Therapy
- ClinicalTrials.gov ID
- NCT05251714
- Acronym / sponsor ID
- TWT-203
- Conditions
- Advanced Solid Tumor, Breast Cancer
- Keywords
- advanced solid tumors, advanced breast cancer, CFI-402257, 2257, fulvestrant, TWT-203, TWT203, UHN
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Treadwell Therapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- 27 May 2022 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 23 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Dose escalation and expansion for monotherapy and combination arms with fulvestrant
| Arm | Type | Receives |
|---|---|---|
| Part A: Monotherapy Escalation and Expansion | Experimental | Drug: CFI-402257Dose selection and expansion of CFI-402257 |
| Part B: Combination Escalation and Expansion | Experimental | Drug: CFI-402257, Drug: FulvestrantDose selection and expansion of CFI-402257 with Fulvestrant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 1. Have histological or cytological proof of advanced cancer that has progressed on at least 1 prior line of systemic therapy
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CFI-402257Also: 2257, 402257Oral once daily in 28 day cycles | Drug | Part A: Monotherapy Escalation and Expansion, Part B: Combination Escalation and Expansion |
| FulvestrantAlso: Faslodex500 mg given by IM injection on Day 1 and Day 15 of Cycle 1 and Day 1 of each subsequent cycle | Drug | Part B: Combination Escalation and Expansion |
Primary outcome
To assess the incidence of adverse events of CFI-402257 as a single agent and at the recommended phase 2 dose (RP2D)
Time frame: 48 months
The number of subjects who experience an adverse event that was possibly related to study drug as assessed by CTCAE v 5.0.
To assess the incidence of adverse events of CFI-402257 in combination with fulvestrant and at the recommended phase 2 dose (RP2D)
Time frame: 48 months
The number of subjects who experience an adverse event that was possibly related to study drug as assessed by CTCAE v 5.0.
5 secondary outcomes
Assessment of objective response rates
Time frame: 48 months
Assessment of objective response rates of the combination
Time frame: 48 months
Assessment of the pharmacokinetic profile of CFI-402257 through AUC
Time frame: 48 months
Assessment of the pharmacokinetic profile of CFI-402257 in combination with fulvestrant through AUC
Time frame: 48 months
To evaluate the effect of CFI-402257 treatment on changes in variant allele function
Time frame: 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Individual participant dataSharing planned: No. It is too early to determine whether we will make IPD available - we do not yet have a process written on this. Field will be updated once our policy / process is written.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R Wesolowski principal investigator
The Ohio State University Comprehensive Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CFI-402257 and Fulvestrant in people with Advanced Solid Tumor and Breast Cancer, run by Treadwell Therapeutics, Inc at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the incidence of adverse events of CFI-402257 as a single agent and at the recommended phase 2 dose (RP2D) (time frame: 48 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.