Dose-Escalation Study of E7727, an Oral Cytidine Deaminase Inhibitor With Oral Decitabine in Subjects With Solid Tumors

Description

This is a phase 1 study of the combination of cedazuridine with decitabine in patients with solid tumors. At least 6 patients will be enrolled per treatment level to assess optimal hypomethylation and toxicity (up to 35 patients total).

Conditions

Solid Tumor

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Study Overview

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Study Details

Study overview

This is a phase 1 study of the combination of cedazuridine with decitabine in patients with solid tumors. At least 6 patients will be enrolled per treatment level to assess optimal hypomethylation and toxicity (up to 35 patients total).

A Phase I Dose-Escalation Study of E7727, an Oral Cytidine Deaminase Inhibitor (CDAi) With Oral Decitabine in Subjects With Solid Tumors

Dose-Escalation Study of E7727, an Oral Cytidine Deaminase Inhibitor With Oral Decitabine in Subjects With Solid Tumors

Condition
Solid Tumor
Intervention / Treatment

-

Contacts and Locations

Los Angeles

USC Norris Comprehensive Cancer Center, Los Angeles, California, United States, 90089

Baltimore

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States, 21231

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Participants must have advanced, unresectable, and/or metastatic solid tumor malignancy that is histologically or cytologically confirmed.
  • * Patients must have received at least 2 lines of therapy in the advanced/metastatic setting (if 2 lines exist) and have no other possible therapies or refuse therapies that have shown clinical benefit for their condition.
  • * ECOG performance status \<1
  • * Ability to understand and the willingness to sign a written informed consent document.
  • * Patients must have measurable disease
  • * Ability to swallow oral medications
  • * Participants who have had chemotherapy or radiotherapy within 3 weeks
  • * Participants may not be receiving any other investigational agents.
  • * Active hepatitis B or hepatitis C infection.
  • * Active or untreated gastric or duodenal ulcer
  • * Symptomatic bowel obstruction within 3 months prior to screening visit.
  • * Symptomatic ascites in the last 4 weeks

Ages Eligible for Study

18 Years to 100 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,

Nilofer Azad, MD, PRINCIPAL_INVESTIGATOR, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Record Dates

2026-12-01