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This research study is studying an investigational drug called EOC237 in Patients With Advanced Solid Tumor.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Dose Escalation | Experimental | 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. |
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| Part 2: Food influence-Group 1 | Experimental | 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. |
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| Part 2: Food influence-Group 2 | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EOC237 | Drug | EOC237 for orally |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Binghe Xu, MD | Contact | 8610-87788495 | cancergcp@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Recruiting | Beijing | Beijing Municipality | 100029 | China |
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