Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT04092673

Study of eFT226 in Subjects With Selected Advanced Solid Tumor Malignancies

Led by Effector Therapeutics · Updated on 2024-05-21

30

Participants Needed

14

Research Sites

283 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Study of eFT226 in Subjects With Selected Advanced Solid Tumor Malignancies

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Histological or cytological confirmation of breast cancer or selected advanced solid tumors
  • Metastatic or locoregionally recurrent disease refractory or intolerant to standard therapies
  • Prior chemotherapy, endocrine therapy, or other treatment for advanced/metastatic disease with at least one but no more than five prior lines
  • Recurrence or progression after at least one line of endocrine therapy in advanced/metastatic setting
  • Prior treatment with a CDK4/6 inhibitor
  • Tumor is estrogen receptor positive (ER IHC staining > 0%) for breast cancer cohorts
  • Specific genetic or biomarker status depending on cohort (e.g., FGFR amplification, HER2 status, KRAS mutations)
Not Eligible

You will not qualify if you...

  • KRAS G12C mutations in relevant cohorts
  • Prior treatment with KRAS-specific therapy in certain cohorts
  • Patients who have not undergone platinum-based chemotherapy and anti-PD-1/L1 agent treatment when appropriate
  • Patients who have progressed after approved anti-HER2 agents and chemotherapy are included only in specific cohorts
  • Patients intolerant to approved therapies may be excluded unless discussed with Medical Monitor
  • Maximum of five prior lines of therapy for advanced/metastatic disease exceeded
  • Absence of required tumor biomarker status for the cohort (e.g., ER negativity when ER+ required)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 14 locations

1

University of Southern California

Los Angeles, California, United States, 90033

Actively Recruiting

2

Valkyrie Clinical Trials

Los Angeles, California, United States, 90067

Actively Recruiting

3

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States, 92663

Completed

4

Stanford University

Palo Alto, California, United States, 94304

Actively Recruiting

5

START Midwest

Grand Rapids, Michigan, United States, 49546

Actively Recruiting

6

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States, 89169

Completed

7

Memorial Sloan Kettering Cancer Center- Monmouth

Middletown, New Jersey, United States, 07748

Actively Recruiting

8

Memorial Sloan Kettering Cancer Center- Commack

Commack, New York, United States, 11725

Actively Recruiting

9

Memorial Sloan Kettering Cancer Center- Westchester

Harrison, New York, United States, 10604

Actively Recruiting

10

Memorial Sloan Kettering Cancer Center- David H. Koch Center for Cancer Care

New York, New York, United States, 11101

Actively Recruiting

11

University of Toledo Medical Center

Toledo, Ohio, United States, 43614

Completed

12

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

13

New Experimental Therapeutics of San Antonio - NEXT Oncology

San Antonio, Texas, United States, 78229

Completed

14

Virginia Cancer Specialists

Fairfax, Virginia, United States, 22031

Actively Recruiting

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Research Team

M

Mark Densel

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

11

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