A Study of EOC237 in Patients With Advanced Solid Tumor

NCT ID: NCT05895825

Last Updated: 2023-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-26

Study Completion Date

2026-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Advanced Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

EOC237

Intervention Type DRUG

EOC237 for orally

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.

Group Type EXPERIMENTAL

EOC237

Intervention Type DRUG

EOC237 for orally

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.

Group Type EXPERIMENTAL

EOC237

Intervention Type DRUG

EOC237 for orally

Interventions

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EOC237

EOC237 for orally

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Yiteng Jingang Bio-pharmaceutical Technology Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Cancer Center/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Binghe Xu, MD

Role: CONTACT

8610-87788495

Facility Contacts

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Binghe Xu

Role: primary

+861087788495

Other Identifiers

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EOC237-X1-101

Identifier Type: -

Identifier Source: org_study_id

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