Study of eFT226 in Subjects With Selected Advanced Solid Tumor Malignancies
NCT ID: NCT04092673
Last Updated: 2024-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2019-10-25
2025-03-31
Brief Summary
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Detailed Description
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Part 1a (Dose Escalation) This cohort will enroll patients with an advanced breast cancer that is refractory or intolerant to SOC therapy.
Part 1b (Dose Escalation) This cohort will enroll patients with an advanced breast cancer that is refractory or intolerant to SOC therapy.
Part 2 (Expansion Cohort) provides defined expansion cohorts to further explore the safety, pharmacology, and clinical activity of eFT226 monotherapy and in various combinations in subjects with previously treated advanced solid tumor malignancies.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1: Sequential escalation (Completed)
eFT226 administered IV weekly in 21-day cycles; dose escalated in sequential cohorts after subjects enrolled in a given cohort have completed DLT evaluation period.
eFT226
eFT226 is a novel small-molecule, investigational drug being developed by eFFECTOR Therapeutics as an anticancer therapy. eFT226 is a potent and selective inhibitor of eIF4A1-mediated translation and selectively regulates the translation of a subset of mRNAs based on sequence specific recognition motifs in their 5'-UTR. eIF4A1 inhibition by eFT226 downregulates expression of receptor tyrosine kinases and KRAS, leading to decreased signaling through the PI3K/AKT and MAPK pathways. Preclinical efficacy testing of eFT226 demonstrates activity across models of solid tumor cancers with amplifications in HER2, FGFR1/2 and mutations in KRAS (including breast, NSCLC and CRC).
Part 2: Cohort Expansion, Monotherapy, NSCLC, KRAS (EMNK)
Cohort EMNK
eFT226
eFT226 is a novel small-molecule, investigational drug being developed by eFFECTOR Therapeutics as an anticancer therapy. eFT226 is a potent and selective inhibitor of eIF4A1-mediated translation and selectively regulates the translation of a subset of mRNAs based on sequence specific recognition motifs in their 5'-UTR. eIF4A1 inhibition by eFT226 downregulates expression of receptor tyrosine kinases and KRAS, leading to decreased signaling through the PI3K/AKT and MAPK pathways. Preclinical efficacy testing of eFT226 demonstrates activity across models of solid tumor cancers with amplifications in HER2, FGFR1/2 and mutations in KRAS (including breast, NSCLC and CRC).
Part 2: Cohort Expansion, Monotherapy, Breast, FGFR (EMBF)
Cohort EMBF
eFT226
eFT226 is a novel small-molecule, investigational drug being developed by eFFECTOR Therapeutics as an anticancer therapy. eFT226 is a potent and selective inhibitor of eIF4A1-mediated translation and selectively regulates the translation of a subset of mRNAs based on sequence specific recognition motifs in their 5'-UTR. eIF4A1 inhibition by eFT226 downregulates expression of receptor tyrosine kinases and KRAS, leading to decreased signaling through the PI3K/AKT and MAPK pathways. Preclinical efficacy testing of eFT226 demonstrates activity across models of solid tumor cancers with amplifications in HER2, FGFR1/2 and mutations in KRAS (including breast, NSCLC and CRC).
Part 2: Cohort Expansion, Monotherapy, Breast, HER2 (EMBH)
Cohort EMBH
eFT226
eFT226 is a novel small-molecule, investigational drug being developed by eFFECTOR Therapeutics as an anticancer therapy. eFT226 is a potent and selective inhibitor of eIF4A1-mediated translation and selectively regulates the translation of a subset of mRNAs based on sequence specific recognition motifs in their 5'-UTR. eIF4A1 inhibition by eFT226 downregulates expression of receptor tyrosine kinases and KRAS, leading to decreased signaling through the PI3K/AKT and MAPK pathways. Preclinical efficacy testing of eFT226 demonstrates activity across models of solid tumor cancers with amplifications in HER2, FGFR1/2 and mutations in KRAS (including breast, NSCLC and CRC).
Part 2: Cohort Expansion, Combination, Breast, Fulvestrant (ECBF)
Cohort ECBF; Combination therapy partner administered per SOC at the approved dose.
Fulvestrant
500 mg administered intramuscularly on Days 1, 15, 29, and once monthly thereafter
Part 2: Cohort Expansion, Combination, NSCLC, Sotorasib (ECNS)
Cohort ECNS; Combination therapy partner administered per SOC at the approved dose.
Sotorasib
Recommended dosage: 960 mg orally once daily
Part 2: Cohort Expansion, Combination, Breast, Fulvestrant+Abemaciclib (ECBF+A)
Cohort ECBF+A; Combination therapy partner administered per SOC at the approved dose.
Fulvestrant
500 mg administered intramuscularly on Days 1, 15, 29, and once monthly thereafter
Abemaciclib
Dose in combination with fulvestrant: 150 mg twice daily
Part 2: Cohort Expansion, Combination, Breast, Trastuzumab (ECBT)
Cohort ECBT; Combination therapy partner administered per SOC at the approved dose.
Trastuzumab
600 mg every 3 weeks
Part 1a: Dose Escalation, Combination, Breast
eFT226 administered IV weekly in 21-day cycles. Fulvestrant will also be given. Dose escalations per protocol.
Fulvestrant
500 mg administered intramuscularly on Days 1, 15, 29, and once monthly thereafter
Part 1b Dose Escalation, Combination, Breast
eFT226 administered IV every other week in 14-day cycles. Fulvestrant will also be given. Dose escalations per protocol.
Fulvestrant
500 mg administered intramuscularly on Days 1, 15, 29, and once monthly thereafter
Part 2 Cohort Expansion, Combination, Breast, Fulvestrant, Cyclin D1
ECBF-D1; Combination therapy partner administered per SOC at the approved dose.
Fulvestrant
500 mg administered intramuscularly on Days 1, 15, 29, and once monthly thereafter
Interventions
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eFT226
eFT226 is a novel small-molecule, investigational drug being developed by eFFECTOR Therapeutics as an anticancer therapy. eFT226 is a potent and selective inhibitor of eIF4A1-mediated translation and selectively regulates the translation of a subset of mRNAs based on sequence specific recognition motifs in their 5'-UTR. eIF4A1 inhibition by eFT226 downregulates expression of receptor tyrosine kinases and KRAS, leading to decreased signaling through the PI3K/AKT and MAPK pathways. Preclinical efficacy testing of eFT226 demonstrates activity across models of solid tumor cancers with amplifications in HER2, FGFR1/2 and mutations in KRAS (including breast, NSCLC and CRC).
Sotorasib
Recommended dosage: 960 mg orally once daily
Fulvestrant
500 mg administered intramuscularly on Days 1, 15, 29, and once monthly thereafter
Abemaciclib
Dose in combination with fulvestrant: 150 mg twice daily
Trastuzumab
600 mg every 3 weeks
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
* Patient has had prior chemotherapy, endocrine therapy, or other therapy as follows:
* Minimum of one prior line of therapy for advanced/metastatic disease.
* Maximum of five prior lines of therapy for advanced/metastatic disease.
* Recurrence or progression on at least one line of endocrine therapy in the advanced/metastatic disease setting, which may include combination therapy (eg, with a CDK4/6 inhibitor).
* Tumor is ER+ (defined as ER IHC staining \> 0%) and has FGFR amplification.
Cohort EMBH:
* Patient has had prior chemotherapy, endocrine therapy, or other therapy as follows:
* Minimum of one prior line of therapy for advanced/metastatic disease.
* Minimum of one line of HER2-directed therapy Note: Prior treatment with CDK4/6 inhibitors is permitted.
* Tumor is ER+ (defined as ER IHC staining \> 0%) and HER2+ (defined as HER2 3+ IHC staining or HER2 2+ and FISH+).
Cohort ECNS:
* Patient has histologically or cytologically confirmed stage IIIB (pleural or pericardial effusion) or stage IV NSCLC.
* Patient has undergone treatment with platinum-based chemotherapy and an anti-PD-1/L1 agent, if appropriate. Note: Patients who have declined approved therapy(ies) or who per treating physician are not eligible for approved therapy(ies) (eg, due to intolerance) may be eligible following discussion with the Medical Monitor.
* Tumor has a known G12C KRAS-activating mutation. Note: Patients who have been previously treated with KRAS-specific therapy are excluded.
Cohort ECBF:
* Patient has had prior chemotherapy, endocrine therapy, or other therapy as follows:
* Minimum of one prior line of therapy for advanced/metastatic disease.
* Maximum of five prior lines of therapy for advanced/metastatic disease.
* Recurrence or progression on at least one line of endocrine therapy in the advanced/metastatic disease setting.
* Prior treatment has included a CDK4/6 inhibitor.
* Tumor is ER+ (defined as ER IHC staining \> 0%).
Cohort ECBF+A:
* Patient has had prior chemotherapy, endocrine therapy, or other therapy as follows:
* Minimum of one prior line of therapy for advanced/metastatic disease.
* Maximum of five prior lines of therapy for advanced/metastatic disease.
* Recurrence or progression on at least one line of endocrine therapy in the advanced/metastatic disease setting.
* Tumor is ER+ (defined as ER IHC staining \> 0%) and HER2- (defined as absence of HER2 3+ IHC staining and/or absence of FISH+).
Cohort ECBT:
* Patient has progressed after treatment with at least one approved anti-HER2 agent and has been administered at least one line of chemotherapy.
* Tumor is HER2+ (defined as HER2 3+ IHC staining or HER2 2+ and FISH+). Cohorts EMBF, EMBH, ECBF, ECBF+A: There is no limit on the number of lines of prior endocrine therapies.
Cohort ECBF-D1:
* Patient has metastatic disease or locoregionally recurrent disease which is refractory or intolerant to existing therapy(ies) known to provide clinical benefit.
* Patient has had prior chemotherapy, endocrine therapy, or other therapy as follows:
* Minimum of one prior line of therapy for advanced/metastatic disease.
* Maximum of five prior lines of therapy for advanced/metastatic disease.
* Recurrence or progression on at least one line of endocrine therapy in the advanced/metastatic disease setting.
* Prior treatment has included a CDK4/6 inhibitor.
* Tumor is ER+ (defined as ER IHC staining \> 0%).
* Tumor has amplification of Cyclin D1 as determined by next generation sequencing or in situ hybridization.
18 Years
ALL
No
Sponsors
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Effector Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Douglas Warner, MD
Role: STUDY_DIRECTOR
EFFECTOR Therapeutics, Inc.
Locations
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University of Southern California
Los Angeles, California, United States
Valkyrie Clinical Trials
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Stanford University
Palo Alto, California, United States
START Midwest
Grand Rapids, Michigan, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Memorial Sloan Kettering Cancer Center- Monmouth
Middletown, New Jersey, United States
Memorial Sloan Kettering Cancer Center- Commack
Commack, New York, United States
Memorial Sloan Kettering Cancer Center- Westchester
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center- David H. Koch Center for Cancer Care
New York, New York, United States
University of Toledo Medical Center
Toledo, Ohio, United States
MD Anderson Cancer Center
Houston, Texas, United States
New Experimental Therapeutics of San Antonio - NEXT Oncology
San Antonio, Texas, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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eFT226-0002
Identifier Type: -
Identifier Source: org_study_id
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