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A Single-Arm, Open-Label, Phase I Study of GK01 for Advanced Solid Tumor

RECRUITINGPhase 1Sponsored by Tianjin Medical University Cancer Institute and Hospital
Actively Recruiting
PhasePhase 1
SponsorTianjin Medical University Cancer Institute and Hospital
Started2025-03-18
Est. completion2028-03-18
Eligibility
Age18 Years – 70 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06954558

Summary

This study is a Phase I, open-label, single-arm clinical trial to evaluate the safety, pharmacokinetics, and preliminary efficacy of GK01 in patients with advanced solid tumors.

Eligibility

Age: 18 Years – 70 YearsHealthy volunteers accepted
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

Conditions2

Advanced Solid TumorsCancer

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