A Study of EOC237 in Patients With Advanced Solid Tumor

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Primary Purpose

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

EOC237

About this trial

This is an interventional treatment trial for Advanced Solid Tumor

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Advanced Solid Tumors for which standard curative or palliative measures do not exist or are no longer effective. Measurable lesion according to RECIST 1.1 evaluation criteria. 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Part 1: Dose Escalation

Part 2: Food influence-Group 1

Part 2: Food influence-Group 2

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Proportion of subjects with dose-limiting toxicity (DLT)

Number of subjects who experienced DLT events during 28 days after first administration of EOC237, divided by the number of DLT evaluable Subjects

Determination of maximum tolerated dose (MTD)

the recommended phase 2 dose (RP2D)

Secondary Outcome Measures

Full Information

NCT ID

NCT05895825

First Posted

May 12, 2023

Last Updated

August 15, 2023

Sponsor

Shanghai Yiteng Jingang Bio-pharmaceutical Technology Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT05895825

Brief Title

A Study of EOC237 in Patients With Advanced Solid Tumor

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 26, 2023 (Actual)

Primary Completion Date

April 30, 2026 (Anticipated)

Study Completion Date

September 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Yiteng Jingang Bio-pharmaceutical Technology Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced Solid Tumor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Part 1: Dose Escalation

Arm Type

Experimental

Arm Description

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.

Arm Title

Part 2: Food influence-Group 1

Arm Type

Experimental

Arm Description

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.

Arm Title

Part 2: Food influence-Group 2

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

EOC237

Intervention Description

EOC237 for orally

Primary Outcome Measure Information:

Title

Proportion of subjects with dose-limiting toxicity (DLT)

Description

Number of subjects who experienced DLT events during 28 days after first administration of EOC237, divided by the number of DLT evaluable Subjects

Time Frame

Up to approximately 3 years

Title

Determination of maximum tolerated dose (MTD)

Time Frame

Up to approximately 3 years

Title

the recommended phase 2 dose (RP2D)

Time Frame

Up to approximately 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Advanced Solid Tumors for which standard curative or palliative measures do not exist or are no longer effective. Measurable lesion according to RECIST 1.1 evaluation criteria. 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Binghe Xu, MD

Phone

8610-87788495

Email

cancergcp@163.com

Facility Information:

Facility Name

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

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100029

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Binghe Xu

Phone

+861087788495

Email

cancergcp@163.com

Advanced Solid Tumor

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial