Advanced Solid TumorsPhase 1GUARDIANNCT06954558
A Single-Arm, Open-Label, Phase I Study of GK01 for Advanced Solid Tumor
A Phase 1 study testing GK01 Injection in people with Advanced Solid Tumors, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- GK01 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 18 Mar 2025to 18 Jul 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin
Jihui Hao, +86-02223340123, haojihui@tjmuch.com
About this study
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
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.
- Conditions
- Advanced Solid Tumors
- Being tested
- GK01 Injection
- Keywords
- efficacy, safety, PK, TILs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GK01 InjectionDrug
Autologous tumor-reactive T cells injection
| Study group | Role | What they receive |
|---|---|---|
| GK01 injection | Experimental | Autologous tumor-reactive T cells injection Receives: Drug: GK01 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
The incidence and severity, and correlation of AEs (Adverse Events) and SAEs (Serious Adverse Events).
Measured: 2 years
Secondary outcomes (7)
PK
Levels of T-cell Receptor copies
Measured: 2 years
Objective response rate (ORR)
Measured: 2 years
Progress-free survival(PFS)
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)
Measured: 2 years
Overall survival (OS )
OS will be assessed from the first GK01 infusion to death from any cause (Assessed based on RECIST criteria)
Measured: 2 years
Disease control rate (DCR)
Measured: 2 years
Patient Quality of Life
EORTC(European Organisation for Research and Treatment of Cancer) QLG (Quality of Life Group)Core Questionnaire (EORTC QLQ-C30)
Measured: 2 years
PD marker
Concentration levels of serum cytokines, such as IL-2, IL-4, IL-6, IL-10, IFN-γ, TNF-α
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start18 Mar 2025
- Primary completion18 Mar 2028 (estimated)
- Study completion18 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Geekgene Technology Co., LTD
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954558
- Sponsor's protocol ID
- GK01IIT-TZ01
- Acronym
- GUARDIAN
- Status last verified
- Mar 2025
- First submitted
- 14 Apr 2025
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06954558
- Acronym / sponsor ID
- GUARDIAN / GK01IIT-TZ01
- Conditions
- Advanced Solid Tumors
- Keywords
- efficacy, safety, PK, TILs
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Collaborators
- Beijing Geekgene Technology Co., LTD
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- 18 Mar 2028 (estimated)
- Study completion
- 18 Jul 2028 (estimated)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GK01 injection | Experimental | Drug: GK01 InjectionAutologous tumor-reactive T cells injection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GK01 InjectionAutologous tumor-reactive T cells injection | Drug | GK01 injection |
Primary outcome
Safety and Tolerability
Time frame: 2 years
The incidence and severity, and correlation of AEs (Adverse Events) and SAEs (Serious Adverse Events).
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Individual participant dataSharing planned: No
Related trials for Advanced Solid Tumors
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 1/2
Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors
Advanced Solid Tumors, Metastatic Solid Tumors
Active, not recruitingPhase 1
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7566802 as a Single Agent and in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
Locally Advanced Solid Tumors, Recurrent Solid Tumors
RecruitingPhase 1
A Study of Sofe-M in Participants With Selected Advanced Solid Tumors
Ovarian Neoplasms, Endometrial Neoplasms
RecruitingPhase 2
Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors
Rectal Adenocarcinoma, Clinical Stage: Stage II (T3-4, N-)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GK01 Injection in people with Advanced Solid Tumors, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jihui Hao (+86-02223340123, haojihui@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.