A Study of EOC237 in Patients With Advanced Solid Tumor

November 1, 2023 updated by: Shanghai Yiteng Jingang Bio-pharmaceutical Technology Co., Ltd

A Phase I Study Evaluating the Safety, Tolerability and Pharmacokinetics of EOC237 in Patients With Advanced Solid Tumor

This research study is studying an investigational drug called EOC237 in Patients With Advanced Solid Tumor.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Part 1 Dose Escalation: an open, single/multiple dose, multi-center phase I study to evaluate the safety, tolerability and pharmacokinetics of EOC237 in Patients With Advanced Solid Tumor.

Part 2 Food influence research: to assess the effect of food on the pharmacokinetics of EOC237, by investigating the bioavailability following single dose administration under fed and fasted conditions.

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100029
        • Recruiting
        • National Cancer Center/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Advanced Solid Tumors for which standard curative or palliative measures do not exist or are no longer effective.
  • Expected survival≥ 3 months.
  • ECOG performance status 0-1.
  • Good organ and marrow function.

Exclusion Criteria:

  • Patients with a history of severe drug allergic reaction.
  • Pregnant or lactating female subjects.
  • Uncontrolled, significant intercurrent or recent illness.
  • Corrected QT interval calculated by the Fridericia formula (QTcF) > 480 ms per electrocardiogram (ECG)
  • Concomitant use of certain medications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1: Dose Escalation
In Part 1 (dose escalation) participants with selected advanced solid tumors will receive escalating doses of EOC237 as monotherapy. Participants can receive EOC237 until disease progression, adverse event (AE), or other discontinuation criteria, whichever occurs first.
Drug: EOC237
EOC237 for orally
Experimental: Part 2: Food influence-Group 1

Food influence-Group 1: EOC237 was taken orally under fasted conditions, after a 3-day washout period, EOC237 was taken orally under fed conditions.

Participants can receive EOC237 until disease progression, AE, or other discontinuation criteria, whichever occurs first.
Drug: EOC237
EOC237 for orally
Experimental: Part 2: Food influence-Group 2

Food influence-Group 2: EOC237 was taken orally under fed conditions, after a 3-day washout period, EOC237 was taken orally under fasted conditions.

Participants can receive EOC237 until disease progression, AE, or other discontinuation criteria, whichever occurs first.
Drug: EOC237
EOC237 for orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects with dose-limiting toxicity (DLT)
Time Frame: Up to approximately 3 years
Number of subjects who experienced DLT events during 28 days after first administration of EOC237, divided by the number of DLT evaluable Subjects
Up to approximately 3 years
Determination of maximum tolerated dose (MTD)
Time Frame: Up to approximately 3 years
Up to approximately 3 years
the recommended phase 2 dose (RP2D)
Time Frame: Up to approximately 3 years
Up to approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Yiteng Jingang Bio-pharmaceutical Technology Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2023

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

May 12, 2023

First Submitted That Met QC Criteria

May 29, 2023

First Posted (Actual)

June 9, 2023

Study Record Updates

Last Update Posted (Actual)

November 2, 2023

Last Update Submitted That Met QC Criteria

November 1, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EOC237-X1-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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