Menu
Recruiting NCT06954558

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

Phase I Interventional Advanced Solid Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GK01 Injection.
Who it may be relevant to
Registry conditions: Advanced Solid Tumors. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Phase I, Open-label, Single-arm Clinical Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of GK01 Cell Injection in Patients With Advanced Solid Tumors

Overview

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.

Interventions

  • Drug GK01 Injection
    Autologous tumor-reactive T cells injection

Primary outcome measures

  • Safety and Tolerability [Time frame: 2 years]
Secondary outcome measures (7)
  • PK [Time frame: 2 years]
  • Objective response rate (ORR) [Time frame: 2 years]
  • Progress-free survival(PFS) [Time frame: 2 years]
  • Overall survival (OS ) [Time frame: 2 years]
  • Disease control rate (DCR) [Time frame: 2 years]
  • Patient Quality of Life [Time frame: 2 years]
  • PD marker [Time frame: 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Tianjin Medical University Cancer Institute & Hospital — Tianjin

Identifiers

NCT: NCT06954558 · GK01IIT-TZ01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗