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Tomivosertib in Relapsed or Refractory Acute Myeloid Leukemia (AML)

NCT05744739 ยท Status: ACTIVE_NOT_RECRUITING ยท Phase: PHASE1 ยท Type: INTERVENTIONAL ยท Enrollment: 15

Last updated 2025-10-21

No results posted yet for this study

Summary

Phase 1 of the study will open first with a (Bayesian optimal interval BOIN) dose finding design. The starting dose of tomivosertib is 100mgdaily (doses 24 ยฑ 2 hours apart), PO, self-administered with meals. The dose finding follows a BOIN design, with the 100mg BID dose level with a meal being the highest dose. There is one dose level below (dose level -1 = 100mg QD without a meal) that will be given if the de-escalation condition is met during dose finding. Upon completion of the phase 1 dose finding portion of the study, the recommended starting dose of tomivosertib for the subsequent combination with the other agents will be determined, as described in Section 4.3 and Section 8.0.

Tomivosertib will be dosed continuously on days 1-28 of each 28-day cycle at the dose level assigned for that cohort.

Conditions

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

DRUG

Tomivosertib

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • EFFECTOR Therapeutics, Inc.

    collaborator UNKNOWN

  • Northwestern University

    lead OTHER

Principal Investigators

  • Shira N Dinner ยท Northwestern University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-29
Primary Completion
2024-08-20
Completion
2030-04-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT05744739 on ClinicalTrials.gov