Investigating EOC237 for patients with advanced solid tumors
A Phase I Study Evaluating the Safety, Tolerability and Pharmacokinetics of EOC237 in Patients With Advanced Solid Tumor
PHASE1 · Shanghai Yiteng Jingang Bio-pharmaceutical Technology Co., Ltd · NCT05895825
This study is testing a new drug called EOC237 in patients with advanced solid tumors to see if it is safe and how food affects how well the drug works.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanghai Yiteng Jingang Bio-pharmaceutical Technology Co., Ltd (industry) |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05895825 on ClinicalTrials.gov |
What this trial studies
This study evaluates the investigational drug EOC237 in patients with advanced solid tumors where standard treatments are ineffective. It consists of two parts: the first part focuses on dose escalation to assess safety, tolerability, and pharmacokinetics of EOC237. The second part investigates how food influences the drug's bioavailability by comparing its effects under fed and fasted conditions.
Who should consider this trial
Good fit: Ideal candidates are patients with advanced solid tumors for which standard treatments are no longer effective and who have a life expectancy of at least three months.
Not a fit: Patients with severe drug allergies, uncontrolled illnesses, or specific ECG abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors.
How similar studies have performed: Other studies have shown promise with similar investigational drugs, but the specific approach of EOC237 is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing Municipality
- National Cancer Center/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, Beijing Municipality, China (RECRUITING)
Study contacts
- Study coordinator: Binghe Xu, MD
- Email: cancergcp@163.com
- Phone: 8610-87788495
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Advanced Solid Tumor