We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03318562
Recruitment Status : Terminated (The study was terminated due to change in focus of the development program)
First Posted : October 24, 2017
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Triple Negative Breast Cancer Hepatocellular Carcinoma Drug: eFT508 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pharmacodynamic Study of Oral eFT508 in Subjects With Advanced Triple Negative Breast Cancer and Hepatocellular Carcinoma
Actual Study Start Date : November 21, 2017
Actual Primary Completion Date : July 5, 2018
Actual Study Completion Date : January 22, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TNBC Cohort
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
Drug: eFT508
200 mg eFT508 dosed BID for 3 week cycles

Experimental: HCC Cohort
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
Drug: eFT508
200 mg eFT508 dosed BID for 3 week cycles




Primary Outcome Measures :
  1. Level of biomarkers of antitumor activation [ Time Frame: 28 days ]
    Biomarkers of antitumor immune activation in pre- and on treatment tumor biopsies and peripheral blood cells


Secondary Outcome Measures :
  1. Molecular profiling of circulating lymphocytes and tumor-infiltrating lymphocytes (TILs) [ Time Frame: up to 3 years ]
    Includes determination of T cell clonality via T cell receptor sequencing

  2. Levels of eIF4E and phospho-eIF4E [ Time Frame: 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

  3. Number of mutations [ Time Frame: up to 3 years ]
    Assessment of mutations will be determined for a subset of known cancer driver genes by sequencing tumor DNA

  4. Objective tumor response [ Time Frame: 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)

  5. Progression Free Survival [ Time Frame: 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

  6. Proportion of subjects with TEAEs and SAEs [ Time Frame: up to 3 years ]
  7. PK plasma concentrations [ Time Frame: up to 21 weeks ]
    taken at the anticipated maximum and minimum plasma concentrations for eFT508



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (TNBC Cohort Only):

  • Women ≥18 years of age
  • Pathologically documented diagnosis of TNBC that is metastatic or locally advanced and unresectable
  • Adequate hepatic function and coagulation profile
  • Negative HIV, HBV and HCV

Inclusion Criteria (HCC Cohort Only):

  • Men or Women ≥18 years of age
  • Histological or cytological confirmed diagnosis of HCC with Barcelona Clinic Liver Cancer Stage B or C who cannot benefit from resection, local ablation, or chemoembolization
  • ECOG performance status of 0 or 1
  • Has at least 1 measurable lesion based on irRECIST 1.1.
  • Negative HIV tests

Inclusion Criteria (Either Cohort):

  • subject agrees to undergo a pre-treatment and an on-treatment biopsy of the tumor
  • Completion of all previous therapy for the treatment of cancer ≥3 weeks before the start of study drug
  • All acute toxic effects of any prior antitumor therapy resolved to Grade ≤1 before the start of study drug
  • Adequate bone marrow and renal function
  • Life expectancy of ≥3 months

Exclusion Criteria (Either Cohort):

  • Pregnant or breastfeeding
  • History of another malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin; in situ cervical carcinoma; adequately treated, papillary, noninvasive bladder cancer; other adequately treated Stage 1 or 2 cancers currently in complete remission; or any other cancer that has been in complete remission for ≥2 years.
  • Gastrointestinal disease that may interfere with drug absorption or with interpretation of GI AEs.
  • Known symptomatic brain metastases requiring ≥10 mg/day of prednisolone (or its equivalent).
  • Significant cardiovascular disease within 6 months prior to start of study drug
  • Ongoing risk for bleeding due to active peptic ulcer disease or bleeding diathesis or requirement for systemic anticoagulation with unfractionated heparin, low-molecular-weight heparin or heparin fractions, or oral anticoagulants.
  • Evidence of an ongoing systemic bacterial, fungal, or viral infection
  • Has received a live vaccine within 30 days of planned start of study drug
  • Major surgery within 4 weeks before the start of study drug
  • Prior solid organ or bone marrow progenitor cell transplantation
  • Prior therapy with any known inhibitor of MNK1 or MNK2
  • Prior high dose chemotherapy requiring stem cell rescue
  • History of or active autoimmune disorders or other conditions that might impair or compromise the immune system
  • Ongoing immunosuppressive therapy, including systemic or enteric corticosteroids
  • Use of a strong inhibitor or inducer of cytochrome P450 (CYP)3A4 within 7 days prior to the start of study drug or expected requirement for use of a strong CYP3A4 inhibitor or inducer during study participation
  • Need for proton pump inhibitors and histamine H2 blockers
  • Previously received investigational product in a clinical trial within 30 days or within 5 elimination half lives (whichever is longer) prior to the start of study drug, or is planning to take part in another clinical trial while participating in this study
  • HCC Cohort Only: Portal vein invasion at the main portal (Vp4), inferior vena cava, or cardiac involvement of HCC based on imaging.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03318562


Locations
Layout table for location information
United States, California
City of Hope
Duarte, California, United States, 91010
United States, Missouri
Kansas City Research Institute
Kansas City, Missouri, United States, 64131
Sponsors and Collaborators
Effector Therapeutics
Investigators
Layout table for investigator information
Study Director: Jeremy Barton, MD CMO
Layout table for additonal information
Responsible Party: Effector Therapeutics
ClinicalTrials.gov Identifier: NCT03318562    
Other Study ID Numbers: eFT508-0008
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Breast Neoplasms
Carcinoma, Hepatocellular
Triple Negative Breast Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Liver Diseases