Study of eFT226 in Subjects With Selected Advanced Solid Tumor Malignancies

Part of paid clinical trials in Los Angeles, California.

Sponsor
Effector Therapeutics
Study ID
NCT04092673
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Solid Tumor, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • eFT226 — DRUG
    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 — DRUG
    Recommended dosage: 960 mg orally once daily
  • Fulvestrant — DRUG
    500 mg administered intramuscularly on Days 1, 15, 29, and once monthly thereafter
  • Abemaciclib — DRUG
    Dose in combination with fulvestrant: 150 mg twice daily
  • Trastuzumab — DRUG
    600 mg every 3 weeks

Study Details

This clinical trial is a Phase 1-2, open-label, sequential-group, dose-escalation and cohort-expansion study evaluating the safety, pharmacokinetics (PK), pharmacodynamics, and antitumor activity of Zotatifin (eFT226) in subjects with selected advanced solid tumor malignancies.

Key Dates

Start date
Oct 25, 2019
Status verified
May 2024
Primary completion
Dec 31, 2024
Completion
Mar 31, 2025

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: Part 2: Cohort Expansion, Monotherapy, NSCLC, KRAS (EMNK)
    Cohort EMNK
  • Experimental: Part 2: Cohort Expansion, Monotherapy, Breast, FGFR (EMBF)
    Cohort EMBF
  • Experimental: Part 2: Cohort Expansion, Monotherapy, Breast, HER2 (EMBH)
    Cohort EMBH
  • Experimental: Part 2: Cohort Expansion, Combination, Breast, Fulvestrant (ECBF)
    Cohort ECBF; Combination therapy partner administered per SOC at the approved dose.
  • Experimental: Part 2: Cohort Expansion, Combination, NSCLC, Sotorasib (ECNS)
    Cohort ECNS; Combination therapy partner administered per SOC at the approved dose.
  • Experimental: Part 2: Cohort Expansion, Combination, Breast, Fulvestrant+Abemaciclib (ECBF+A)
    Cohort ECBF+A; Combination therapy partner administered per SOC at the approved dose.
  • Experimental: Part 2: Cohort Expansion, Combination, Breast, Trastuzumab (ECBT)
    Cohort ECBT; Combination therapy partner administered per SOC at the approved dose.
  • Experimental: Part 1a: Dose Escalation, Combination, Breast
    eFT226 administered IV weekly in 21-day cycles. Fulvestrant will also be given. Dose escalations per protocol.
  • Experimental: 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.
  • Experimental: Part 2 Cohort Expansion, Combination, Breast, Fulvestrant, Cyclin D1
    ECBF-D1; Combination therapy partner administered per SOC at the approved dose.

Primary Outcome Measure

Parts 1a and 1b: MTD [ Time Frame: Through study completion, approximately 12 months ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
University of Southern CaliforniaLos AngelesCalifornia90033
Xiomara Menendez
[email protected]
323-409-4638
Anthony El-Khoueiry, MD (PRINCIPAL_INVESTIGATOR)
Valkyrie Clinical TrialsLos AngelesCalifornia90067
Chemyn Cortez
[email protected]
559-360-3707
David Berz, MD (PRINCIPAL_INVESTIGATOR)
Hoag Memorial Hospital PresbyterianNewport BeachCalifornia92663-
Stanford UniversityPalo AltoCalifornia94304
Kaushali Thakore-Shah
[email protected]
Jennifer Caswell-Jin, MD (PRINCIPAL_INVESTIGATOR)
START MidwestGrand RapidsMichigan49546
Abigail Van Kirk
[email protected]
616-954-5550
Manish Sharma, MD (PRINCIPAL_INVESTIGATOR)
Comprehensive Cancer Centers of NevadaLas VegasNevada89169-
Memorial Sloan Kettering Cancer Center- MonmouthMiddletownNew Jersey07748
Colleen Wenzel
[email protected]
Ezra Rosen, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer Center- CommackCommackNew York11725
Ezra Rosen, MD
[email protected]
Colleen Wenzel
[email protected]
Ezra Rosen, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer Center- WestchesterHarrisonNew York10604
Colleen Wenzel
[email protected]
Ezra Rosen, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer Center- David H. Koch Center for Cancer CareNew YorkNew York11101
Ezra Rosen, MD
[email protected]
Colleen Wenzel
[email protected]
Ezra Rosen, MD (PRINCIPAL_INVESTIGATOR)
University of Toledo Medical CenterToledoOhio43614-
MD Anderson Cancer CenterHoustonTexas77030
Amanda Ekert
[email protected]
713-745-8074
Funda Meric-Bernstam, MD (PRINCIPAL_INVESTIGATOR)
New Experimental Therapeutics of San Antonio - NEXT OncologySan AntonioTexas78229-
Virginia Cancer SpecialistsFairfaxVirginia22031
Karina Castillo-Grady
[email protected]
703-280-5390
Alexander Spira, MD (PRINCIPAL_INVESTIGATOR)

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