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NCT Number: NCT05895825

A Study of EOC237 in Patients With Advanced Solid Tumor

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

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Key information

Conditions

Advanced Solid Tumor

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

National Cancer Center/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100029, China

Location status: Recruiting

Location contact

Binghe Xu

CONTACT

[email protected]

+861087788495

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EOC237

Drug

EOC237 for orally

Primary outcomes

  1. Proportion of subjects with dose-limiting toxicity (DLT)

    Time frame: 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

  2. Determination of maximum tolerated dose (MTD)

    Time frame: Up to approximately 3 years

  3. the recommended phase 2 dose (RP2D)

    Time frame: Up to approximately 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Binghe Xu, MD

CONTACT

[email protected]

8610-87788495

Sponsors and collaborators

Lead sponsor

Shanghai Yiteng Jingang Bio-pharmaceutical Technology Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 9, 2023
Registry last updated
Nov 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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