A Phase 1-2 Dose-Escalation and Cohort-Expansion Study of Oral Tomivosertib (eFT-508) in Subjects With Hematological Malignancies

This clinical trial is a Phase 1-2, open-label, sequential-group, dose-escalation and cohort-expansion study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of Tomivosertib (eFT-508). The study will evaluate oral daily administration of Tomivosertib (eFT-508). Treatment and study subject evaluation will be performed in 21-day cycles.

Study Overview

• Status: Terminated
• Conditions: Lymphoma
• Intervention / Treatment: Drug: Tomivosertib (eFT-508)

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
  • Florida
    • Sarasota, Florida, United States, 34232
      • Florida Cancer Specialist
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Institute
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester
  • Ohio
    • Canton, Ohio, United States, 44718
      • Gabrail Cancer Center Research
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor Scott & White Research Institute
  • Washington
    • Seattle, Washington, United States, 98109
      • Seattle Cancer Care Alliance
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
2. Presence of an active hematological malignancy.
3. Presence of measurable disease.
4. Hematological malignancy has been previously treated, has relapsed after or progressed during prior therapy, and has limited potential for benefit from currently available therapy including hematopoietic stem cell transplantation.
5. At least 2 weeks post any treatments/therapies at the time of first dose.
6. Adequate bone marrow function.
7. Adequate hepatic function.
8. Adequate renal function.
9. Normal coagulation panel.
10. Negative antiviral serology.
11. Willingness to use effective contraception.

Exclusion Criteria:

1. Central nervous system malignancy
2. Gastrointestinal disease
3. Significant cardiovascular disease
4. Significant ECG abnormalities.
5. Ongoing risk for bleeding due to active peptic ulcer disease, bleeding diathesis or requirement for systemic anticoagulation
6. Ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infections)
7. Pregnancy or breastfeeding.
8. Major surgery within 4 weeks before the start of study therapy.
9. Ongoing immunosuppressive therapy, including systemic or enteric corticosteroids
10. Use of drugs that could prolong the QT interval within 7 days before the start of study therapy.
11. Use of drugs that might pose a risk of a drug-drug interaction within 2-7 days before the start of study therapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tomivosertib (eFT-508) Escalation Cohort; This portion of the study will evaluate the safety and pharmacology of a range of Tomivosertib (eFT-508) doses administered daily in subjects with previously treated lymphomas	Drug: Tomivosertib (eFT-508); eFT508
Experimental: Tomivosertib (eFT-508) Expansion Cohort; This portion of the study provides cohort expansion to further explore the safety, pharmacology, and clinical activity of a single dose level of Tomivosertib (eFT-508) monotherapy in subjects with specific previously treated lymphomas	Drug: Tomivosertib (eFT-508); eFT508

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum Tolerated Dose and/or Recommended Dose within the tested Tomivosertib (eFT-508) dose range	up to one year
Overall Response Rate	up to three years

Collaborators and Investigators

• Sponsor: Effector Therapeutics
• Investigators: Study Director: Jeremy Barton, MD, CMO

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2017
• Primary Completion (Actual): November 12, 2018
• Study Completion (Actual): April 4, 2019

Study Registration Dates

• First Submitted: October 17, 2016
• First Submitted That Met QC Criteria: October 17, 2016
• First Posted (Estimate): October 18, 2016

Study Record Updates

• Last Update Posted (Actual): November 2, 2020
• Last Update Submitted That Met QC Criteria: October 30, 2020
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: immunomodulator; small molecule inhibitor of protein translation; phase 1 dose escalation
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: eFT508-0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No