Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Gland and Hormone Related Diseases

Melanoma

Thyroid Diseases

Herbal and Botanical

All Drugs and Chemicals

Cola

Will be given orally once or twice daily. Each treatment cycle = 21 days.

eFT508

Jeremy Barton, MD

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 daily oral administration of eFT508.

eFT508 is an oral, potent and highly selective inhibitor of mitogen-activated protein kinase interacting kinase (MNK) 1 and 2. Dysregulated translation of messenger RNA (mRNA) plays a role in the pathogenesis of multiple solid tumors and hematological malignancies. MNK1 and MNK2 integrate signals from several oncogenic and immune signaling pathways (including RAS, p38 and Toll-like receptors) by phosphorylating eukaryotic initiation of factor 4E (eIF4E) and key effector proteins. Phosphorylation of these regulatory proteins by MNK1 and MNK2 selectively regulates the stability and translation of a subset of cellular mRNA that control tumor growth, the tumor microenvironment and immune signaling. Nonclinical studies indicate that eFT508 shows activity against various types of solid tumors. These nonclinical studies support initiation of clinical development of eFT508 in patients with cancer.

A Dose Escalation and Cohort-Expansion Study of Oral eFT508 in Subjects With Advanced Solid Tumors

A Phase 1-2 Dose Escalation and Cohort-Expansion Study of Oral eFT508 in Subjects With Advanced Solid Tumors

Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE v. 4.03)

Effector Therapeutics

Digestive System Diseases

Carcinoma

Breast Neoplasms

Triple Negative Breast Neoplasms

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

Sorafenib

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

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

200 mg eFT508 dosed BID for 3 week cycles

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.

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

A Pharmacodynamic Study of Oral eFT508 in Subjects With Advanced Triple Negative Breast Cancer and Hepatocellular Carcinoma

Biomarkers of antitumor immune activation in pre- and on treatment tumor biopsies and peripheral blood cells

Includes determination of T cell clonality via T cell receptor sequencing

Assessment of eIF4E and phospho-eIF4E in tumor biopsies by immunohistochemistry, and in circulating peripheral blood cells by phospho-flow cytometry

Assessment of mutations will be determined for a subset of known cancer driver genes by sequencing tumor DNA

determined by irRECIST 1.1, defined as the proportion of subjects who achieve a complete response (CR) or partial response (PR)

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

taken at the anticipated maximum and minimum plasma concentrations for eFT508

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Avelumab

Antineoplastic Agents, Immunological

subjects will receive eFT508 in combination with a fixed dose of avelumab

eFT508 will be taken orally (PO) twice a day (bid).

Avelumab 10 mg/kg will be administered intravenously (IV) on Day 1 and once every 2 weeks (q2wk) thereafter

This is a Phase 2, open-label, 2-part, multicenter study in subjects with MSS relapsed/refractory colorectal cancer. The primary objective of Part 1 is to evaluate the safety and tolerability of escalating doses of eFT508 in combination with a fixed dose of avelumab to determine the maximum tolerated dose (MTD) of eFT508 and to select a recommended dose for Part 2. The primary objective of Part 2 is to evaluate antitumor activity of eFT508 at the recommended dose in combination with avelumab or eFT508 monotherapy. Parts 1 and 2 will also evaluate pharmacokinetics (PK) and pharmacodynamics.

In Part 1, subjects will receive eFT508 in combination with a fixed dose of avelumab. Once the recommended dose of eFT508 in combination with avelumab is determined in Part 1, enrollment in Part 2 will begin. Subjects will be randomized in approximately a 2:1 ratio to receive eFT508 in combination with avelumab or eFT508 monotherapy.

A Study to Evaluate eFT508 Alone and in Combination With Avelumab in Subjects With MSS Colorectal Cancer

A Phase 2, Open-Label, Randomized, Non-Comparative Study With Preliminary Dose Finding to Evaluate eFT508 Monotherapy or eFT508 in Combination With Avelumab in Subjects With Microsatellite Stable Relapsed or Refractory Colorectal Cancer

the proportion of subjects whose best overall response is a complete or partial response

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Dose Escalation and Cohort-Expansion Study of Oral eFT508 in Subjects With Advanced Solid Tumors	NCT02605083	Cancer	eFT508	18 Years -	Effector Therapeutics
A PD Study of Oral eFT508 in Subjects With Advanced TNBC and HCC	NCT03318562	Triple Negative... Hepatocellular ...	eFT508	18 Years -	Effector Therapeutics
A Study to Evaluate eFT508 Alone and in Combination With Avelumab in Subjects With MSS Colorectal Cancer	NCT03258398	Microsatellite ...	eFT508 Avelumab	18 Years -	Effector Therapeutics
A Dose Escalation and Cohort-Expansion Study of Oral eFT508 in Subjects With Advanced Solid Tumors	NCT02605083	Cancer	eFT508	18 Years -	Effector Therapeutics
A Study to Evaluate eFT508 Alone and in Combination With Avelumab in Subjects With MSS Colorectal Cancer	NCT03258398	Microsatellite ...	eFT508 Avelumab	18 Years -	Effector Therapeutics

Spots Global Cancer Trial Database for eft508

Every month we try and update this database with for eft508 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for eft508

Every month we try and update this database with for eft508 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for eft508 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.