A PD Study of Oral eFT508 in Subjects With Advanced TNBC and HCC

Phase 2

Terminated

• Conditions: Triple Negative Breast Cancer; Hepatocellular Carcinoma
• Interventions: Drug: eFT508

• Registration Number: NCT03318562
• Lead Sponsor: Effector Therapeutics

Brief Summary

This study will evaluate the pharmacodynamic (PD), safety, antitumor activity, and PK of eFT508 in female subjects who have pathologically documented, radiographically measurable, metastatic or locally advanced and unresectable TNBC and have received prior cancer therapy regimen for metastatic disease, and in male and female subjects who have histologically or cytologically confirmed advanced HCC not amenable to surgical resection and have failed systemic therapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-19
• Study First Submitted QC: 2017-10-19
• Study First Posted: 2017-10-24
• Study Start: 2017-11-21
• Status Verified: 2017-12
• Primary Completion: 2018-07-05
• Study Completion: 2019-01-22
• Last Update Submitted: 2019-07-16
• Last Update Posted: 2019-07-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HCC Cohort	eFT508	male and female subjects who have histologically or cytologically confirmed advanced HCC not amenable to surgical resection and have failed \>=1 systemic therapy, which must include sorafenib, or are intolerant to multikinase inhibitor therapies
TNBC Cohort	eFT508	female subjects who have pathologically documented, radiographically measurable, metastatic or locally advanced and unresectable TNBC and have received \>=1 prior cancer therapy regimen for metastatic disease

Primary Outcome Measures

Name	Time	Method
Level of biomarkers of antitumor activation	28 days	Biomarkers of antitumor immune activation in pre- and on treatment tumor biopsies and peripheral blood cells

Secondary Outcome Measures

Name	Time	Method
Objective tumor response	up to 3 years	determined by irRECIST 1.1, defined as the proportion of subjects who achieve a complete response (CR) or partial response (PR)
Progression Free Survival	up to 3 years	as determined by irRECIST 1.1, defined as the interval from the start of study drug to the earlier of the first documentation of disease progression or death from any cause
Number of mutations	up to 3 years	Assessment of mutations will be determined for a subset of known cancer driver genes by sequencing tumor DNA
PK plasma concentrations	up to 21 weeks	taken at the anticipated maximum and minimum plasma concentrations for eFT508
Molecular profiling of circulating lymphocytes and tumor-infiltrating lymphocytes (TILs)	up to 3 years	Includes determination of T cell clonality via T cell receptor sequencing
Levels of eIF4E and phospho-eIF4E	up to 3 years	Assessment of eIF4E and phospho-eIF4E in tumor biopsies by immunohistochemistry, and in circulating peripheral blood cells by phospho-flow cytometry
Proportion of subjects with TEAEs and SAEs	up to 3 years

Trial Locations

Locations (2)

City of Hope; 🇺🇸 Duarte, California, United States

Kansas City Research Institute; 🇺🇸 Kansas City, Missouri, United States