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

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02937675

Enrollment

Registered

2016-10-18

Start date

2017-02-08

Completion date

2019-04-04

Last updated

2020-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

Keywords

small molecule inhibitor of protein translation, immunomodulator, phase 1 dose escalation

Brief summary

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.

Interventions

DRUGTomivosertib (eFT-508)

eFT508

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026