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NCT Number: NCT06954558

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

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.

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

Location status: Recruiting

Location contact

Jihui Hao

CONTACT

[email protected]

+86-02223340123

Who can participate

Healthy volunteers accepted: No

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

  • 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

Treatment and study plan

GK01 Injection

Drug

Autologous tumor-reactive T cells injection

Primary outcomes

  1. Safety and Tolerability

    Time frame: 2 years

    The incidence and severity, and correlation of AEs (Adverse Events) and SAEs (Serious Adverse Events).

Secondary outcomes

  1. PK

    Time frame: 2 years

    Levels of T-cell Receptor copies

  2. Objective response rate (ORR)

    Time frame: 2 years

  3. Progress-free survival(PFS)

    Time frame: 2 years

    PFS will be assessed from the first GK01 infusion to death from any cause or the first assessment of progression (Assessed based on RECIST criteria)

  4. Overall survival (OS )

    Time frame: 2 years

    OS will be assessed from the first GK01 infusion to death from any cause (Assessed based on RECIST criteria)

  5. Disease control rate (DCR)

    Time frame: 2 years

  6. Patient Quality of Life

    Time frame: 2 years

    EORTC(European Organisation for Research and Treatment of Cancer) QLG (Quality of Life Group)Core Questionnaire (EORTC QLQ-C30)

  7. PD marker

    Time frame: 2 years

    Concentration levels of serum cytokines, such as IL-2, IL-4, IL-6, IL-10, IFN-γ, TNF-α

Study contacts

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

Jihui Hao

CONTACT

[email protected]

+86-02223340123

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Other

Collaborators

  • Beijing Geekgene Technology Co., LTD

Registry information

Official study 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

Acronym: GUARDIAN

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 1, 2025
Registry last updated
May 1, 2025

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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