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Trial Title:
A Study of EOC237 in Patients With Advanced Solid Tumor
NCT ID:
NCT05895825
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
EOC237
Description:
EOC237 for orally
Arm group label:
Part 1: Dose Escalation
Arm group label:
Part 2: Food influence-Group 1
Arm group label:
Part 2: Food influence-Group 2
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
National Cancer Center/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Address:
City:
Beijing
Zip:
100029
Country:
China
Status:
Recruiting
Contact:
Last name:
Binghe Xu
Phone:
+861087788495
Email:
cancergcp@163.com
Start date:
July 26, 2023
Completion date:
September 30, 2026
Lead sponsor:
Agency:
Shanghai Yiteng Jingang Bio-pharmaceutical Technology Co., Ltd
Agency class:
Industry
Source:
Shanghai Yiteng Jingang Bio-pharmaceutical Technology Co., Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05895825
