A Study of EOC237 in Patients With Advanced Solid Tumor
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EOC237.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumor. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase I Study Evaluating the Safety, Tolerability and Pharmacokinetics of EOC237 in Patients With Advanced Solid Tumor
Overview
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
- Drug EOC237
EOC237 for orally
Primary outcome measures
- Proportion of subjects with dose-limiting toxicity (DLT) [Time frame: Up to approximately 3 years]
- Determination of maximum tolerated dose (MTD) [Time frame: Up to approximately 3 years]
- the recommended phase 2 dose (RP2D) [Time frame: Up to approximately 3 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- National Cancer Center/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Un — Beijing
Identifiers
NCT: NCT05895825 · EOC237-X1-101