Advanced Solid Tumor
Conditions
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.
Interventions
DRUGEOC237
EOC237 for orally
Sponsors
Shanghai Yiteng Jingang Bio-pharmaceutical Technology Co., Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
China
Contacts
Primary ContactBinghe Xu, MD
Outcome results
None listed