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

Effector Therapeutics

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Lymphoma

Treatments: Drug: Tomivosertib (eFT-508)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02937675

eFT508-0002

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Tomivosertib (eFT-508) Escalation Cohort

Experimental group

Description:

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

Treatment:

Drug: Tomivosertib (eFT-508)

Tomivosertib (eFT-508) Expansion Cohort

Experimental group

Description:

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

Treatment:

Drug: Tomivosertib (eFT-508)