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Study of eFT226 in Subjects With Selected Advanced Solid Tumor Malignancies

NCT04092673 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-05-21

No results posted yet for this study

Summary

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.

Conditions

  • Solid Tumor, Adult

Interventions

DRUG

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).

DRUG

Sotorasib

Recommended dosage: 960 mg orally once daily

DRUG

Fulvestrant

500 mg administered intramuscularly on Days 1, 15, 29, and once monthly thereafter

DRUG

Abemaciclib

Dose in combination with fulvestrant: 150 mg twice daily

DRUG

Trastuzumab

600 mg every 3 weeks

Sponsors & Collaborators

  • Effector Therapeutics

    lead INDUSTRY

Principal Investigators

  • Douglas Warner, MD · EFFECTOR Therapeutics, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-25
Primary Completion
2024-12-31
Completion
2025-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04092673 on ClinicalTrials.gov