A Study of EOC237 in Patients With Advanced Solid Tumor

Study Overview
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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.

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

Conditions
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Advanced Solid Tumor

Intervention / Treatment
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* Drug: EOC237


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1: Dose Escalation<br>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<br>* EOC237 for orally<br>|
| Experimental: Part 2: Food influence-Group 1<br>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<br>* EOC237 for orally<br>|
| Experimental: Part 2: Food influence-Group 2<br>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<br>* EOC237 for orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Up to approximately 3 years | 
| Determination of maximum tolerated dose (MTD) |  | Up to approximately 3 years | 
| the recommended phase 2 dose (RP2D) |  | Up to approximately 3 years |