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

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ClinicalTrials.gov Identifier: NCT05251714
Recruitment Status : Recruiting
First Posted : February 23, 2022
Last Update Posted : February 6, 2023
Sponsor:
Information provided by (Responsible Party):
Treadwell Therapeutics, Inc

Study Description
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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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Breast Cancer Drug: CFI-402257 Drug: Fulvestrant Phase 1 Phase 2

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Dose escalation and expansion for monotherapy and combination arms with fulvestrant
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 27, 2022
Estimated Primary Completion Date : August 2025
Estimated Study Completion Date : August 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Fulvestrant

Arms and Interventions
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Arm Intervention/treatment
Experimental: Part A: Monotherapy Escalation and Expansion
Dose selection and expansion of CFI-402257
 Drug: CFI-402257
Oral once daily in 28 day cycles
Other Names:
  • 2257
  • 402257
Experimental: Part B: Combination Escalation and Expansion
Dose selection and expansion of CFI-402257 with Fulvestrant
 Drug: CFI-402257
Oral once daily in 28 day cycles
Other Names:
  • 2257
  • 402257

Drug: Fulvestrant
500 mg given by IM injection on Day 1 and Day 15 of Cycle 1 and Day 1 of each subsequent cycle
Other Name: Faslodex


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Assessment of objective response rates [ Time Frame: 48 months ]
    Objective response rate will be summarized by dose cohort and overall using the percent of patients in each tumor response category.

  2. Assessment of objective response rates of the combination [ Time Frame: 48 months ]
    Objective response rate will be summarized overall for advanced breast cancer patients

  3. Assessment of the pharmacokinetic profile of CFI-402257 through AUC [ Time Frame: 48 months ]
    Area under the plasma concentration (AUC) versus time curve from time 0 to time of least measurable concentration tabulated by dose group.

  4. Assessment of the pharmacokinetic profile of CFI-402257 in combination with fulvestrant through AUC [ Time Frame: 48 months ]
    Area under the plasma concentration (AUC) versus time curve from time 0 to time of least measurable concentration tabulated by dose group.

  5. To evaluate the effect of CFI-402257 treatment on changes in variant allele function [ Time Frame: 48 months ]
    Changes in variant allele function will be measured by looking at circulating tumor deoxyribonucleic acid compared to baseline


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Part A

  1. Have histological or cytological proof of advanced cancer that has progressed on at least 1 prior line of systemic therapy.
  2. Have measurable or nonmeasurable disease as per RECIST 1.1 guidelines or other appropriate disease assessment guidelines.
  3. Are ≥18 years of age.
  4. Have clinically acceptable laboratory screening results (i.e., clinical chemistry, hematology, and urinalysis) within certain limits specified.
  5. Have an ECOG performance status of 0 or 1.
  6. Be able to swallow oral medications.
  7. Have a life expectancy of greater than 3 months.
  8. Women and men of childbearing potential must agree to use highly effective means of contraception.
  9. A negative serum pregnancy test within 72 hours prior to the initiation of protocol therapy..
  10. Can understand the requirements of the study, provide written informed consent.

Inclusion Criteria: Part B

  1. Have histologically and/or cytologically confirmed diagnosis of breast cancer positive for estrogen receptor (ER) and/or progesterone receptor (PR) and negative for HER2 for which no curative therapy exists.

  2. Prior therapy:

    • Must have previously received at least 1 and no more than 3 lines of endocrine therapy (ET), either as monotherapy or as a combination therapy with CDK4/6 inhibitor for breast cancer.
    • Must have progressed during or within 28 days of completion of prior treatment with a CDK4/6 inhibitor in combination an AI or tamoxifen.
    • Must have received no more than 1 line of cytotoxic chemotherapy in the advanced/metastatic setting.
  3. Have measurable or nonmeasurable disease as per RECIST 1.1 guidelines.
  4. Are female or male
  5. Are ≥18 years of age
  6. Are postmenopausal. Premenopausal or perimenopausal patients are required to receive goserelin for at least 4 weeks before the start of study drug.
  7. Have clinically acceptable laboratory screening results (i.e., clinical chemistry, hematology, and urinalysis) within certain limits.
  8. Have an ECOG performance status of 0 or 1.
  9. Be able to swallow oral medications.
  10. Have a life expectancy greater than 3 months.
  11. Women of childbearing potential must agree to use highly effective means of contraception.
  12. A negative serum pregnancy test within 72 hours prior to the initiation of protocol therapy will be required for women of childbearing potential.
  13. Can understand the requirements of the study, provide written informed consent.

Exclusion Criteria: All Parts

  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 CYP3A sensitive substrates, PgP, BCRP inhibitors prior to the first dose of CFI-402257.
  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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05251714


Contacts
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Contact: Treadwell Therapeutics Clinical Trials +1-416-455-7510 clinicaltrials@treadwelltx.com

Locations
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United States, Ohio
The Ohio State University Comprehensive Cancer Center Not yet recruiting
Columbus, Ohio, United States, 43210
Contact: R Wesolowski         
United States, Texas
START San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Muralidhar Beeram         
United States, Utah
START - Mountain Region Recruiting
West Valley City, Utah, United States, 84119
Contact: Justin Call         
Contact: Casey Larsen       casey.larsen@startthecure.com   
United States, Virginia
Virginia Cancer Specialist Recruiting
Fairfax, Virginia, United States, 22031
Contact: Melissa Hackmaster       melissa.hackmaster@usoncology.com   
Sponsors and Collaborators
Treadwell Therapeutics, Inc
Investigators
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Principal Investigator: R Wesolowski The Ohio State University Comprehensive Cancer Center
More Information
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Responsible Party: Treadwell Therapeutics, Inc
ClinicalTrials.gov Identifier: NCT05251714    
Other Study ID Numbers: TWT-203
First Posted: February 23, 2022    Key Record Dates
Last Update Posted: February 6, 2023
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Treadwell Therapeutics, Inc:
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
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Antineoplastic Agents, Hormonal
 Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs