A Study of EOC237 in Patients With Advanced Solid Tumor

Advanced Solid Tumor Clinical Trial

Official title:

A Phase I Study Evaluating the Safety, Tolerability and Pharmacokinetics of EOC237 in Patients With Advanced Solid Tumor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05895825
• Other study ID #: EOC237-X1-101
• Status: Recruiting
• Phase: Phase 1
• Start date: July 26, 2023
• Est. completion date: September 30, 2026

Study information

• Verified date: May 2023
• Source: Shanghai Yiteng Jingang Bio-pharmaceutical Technology Co., Ltd
• Contact: Binghe Xu, MD
• Phone: 8610-87788495
• Email: cancergcp[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research study is studying an investigational drug called EOC237 in Patients With Advanced Solid Tumor.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: September 30, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• EOC237
EOC237 for orally

Locations

Country	Name	City	State
China	National Cancer Center/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Yiteng Jingang Bio-pharmaceutical Technology Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Determination of maximum tolerated dose (MTD)		Up to approximately 3 years
Primary	the recommended phase 2 dose (RP2D)		Up to approximately 3 years