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

T

Tianjin Medical University

Status and phase

Enrolling
Phase 1

Conditions

Advanced Solid Tumors

Treatments

Drug: GK01 Injection

Study type

Interventional

Funder types

Other

Identifiers

NCT06954558
GK01IIT-TZ01

Details and patient eligibility

About

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.

Enrollment

15 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

  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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

GK01 injection
Experimental group
Description:
Autologous tumor-reactive T cells injection
Treatment:
Drug: GK01 Injection

Trial contacts and locations

1

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Central trial contact

Jihui Hao

Data sourced from clinicaltrials.gov

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