A Study of EOC237 in Patients With Advanced Solid Tumor

Sponsor

Shanghai Yiteng Jingang Bio-pharmaceutical Technology Co., Ltd (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05895825

Collaborator

(none)

Enrollment

Arms

39.5

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumor	Drug: EOC237	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 15, 2023

Anticipated Primary Completion Date :

Apr 30, 2026

Anticipated Study Completion Date :

Sep 30, 2026

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Proportion of subjects with dose-limiting toxicity (DLT) [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
Determination of maximum tolerated dose (MTD) [Up to approximately 3 years]
the recommended phase 2 dose (RP2D) [Up to approximately 3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Shanghai Yiteng Jingang Bio-pharmaceutical Technology Co., Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shanghai Yiteng Jingang Bio-pharmaceutical Technology Co., Ltd

ClinicalTrials.gov Identifier:

NCT05895825

Other Study ID Numbers:

EOC237-X1-101

First Posted:

Jun 9, 2023

Last Update Posted:

Jun 12, 2023

Last Verified:

May 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of Jun 12, 2023