A Study of EOC237 in Patients With Advanced Solid Tumor

Phase 1

Recruiting

• Conditions: Advanced Solid Tumor
• Interventions: Drug: EOC237

• Registration Number: NCT05895825
• Lead Sponsor: Shanghai Yiteng Jingang Bio-pharmaceutical Technology Co., Ltd

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.

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-12
• Study First Submitted QC: 2023-05-29
• Study First Posted: 2023-06-09
• Study Start: 2023-07-26
• Last Update Submitted: 2023-11-01
• Last Update Posted: 2023-11-02
• Primary Completion: 2026-04-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part 1: Dose Escalation	EOC237	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.
Part 2: Food influence-Group 2	EOC237	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.
Part 2: Food influence-Group 1	EOC237	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

National Cancer Center/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; 🇨🇳 Beijing, Beijing, China