Testing GK01 for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase I clinical trial evaluates the safety, pharmacokinetics, and preliminary efficacy of GK01 in patients with advanced solid tumors. It is an open-label, single-arm study, meaning all participants will receive the GK01 injection without a control group. The trial aims to determine how well GK01 works in patients who have not responded to standard treatments or cannot tolerate them. Participants must have measurable tumor lesions and adequate organ function to qualify for the study.

Why it matters

Who can join: the full rules

1. Ability to understand and sign a written informed consent document；
2. At the date of signing ICF, 18 \~70 years old, male or female；
3. Histopathological confirmed advanced solid tumor patients who have failed to standard treatment or intolerance with standard treatment；
4. There is at least one resectable tumor lesion that has not received radiation therapy or other local therapies;
5. At least one measurable lesion at baseline per RECIST version 1.1；
6. The expected survival time is more than 12 weeks;
7. ECOG 0-1 points;
8. Adequate organ functions

Where it's running

• Tianjin Medical University Cancer Institute & Hospital
  Tianjin, China Recruiting

Study contacts

• Study coordinator: Jihui Hao
• Email: haojihui@tjmuch.com
• Phone: +86-02223340123

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.