A Study of EOC237 in Patients With Advanced Solid Tumor
NCT ID: NCT05895825
Last Updated: 2023-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
48 participants
INTERVENTIONAL
2023-07-26
2026-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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.
EOC237
EOC237 for orally
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.
EOC237
EOC237 for orally
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.
EOC237
EOC237 for orally
Interventions
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EOC237
EOC237 for orally
Eligibility Criteria
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Inclusion Criteria
* Expected survival≥ 3 months.
* ECOG performance status 0-1.
* Good organ and marrow function.
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Yiteng Jingang Bio-pharmaceutical Technology Co., Ltd
INDUSTRY
Responsible Party
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Locations
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National Cancer Center/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EOC237-X1-101
Identifier Type: -
Identifier Source: org_study_id
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