NCT06954558

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
27mo left

Started Mar 2025

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Mar 2025Jul 2028

Study Start

First participant enrolled

March 18, 2025

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 1, 2025

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2028

Last Updated

May 1, 2025

Status Verified

March 1, 2025

Enrollment Period

3 years

First QC Date

April 14, 2025

Last Update Submit

April 24, 2025

Conditions

Advanced Solid Tumors

Keywords

efficacysafetyPKTILs

Outcome Measures

Primary Outcomes (1)

  • Safety and Tolerability

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

    2 years

Secondary Outcomes (7)

  • PK

    2 years

  • Objective response rate (ORR)

    2 years

  • Progress-free survival(PFS)

    2 years

  • Overall survival (OS )

    2 years

  • Disease control rate (DCR)

    2 years

  • +2 more secondary outcomes

Study Arms (1)

GK01 injection

EXPERIMENTAL

Autologous tumor-reactive T cells injection

Drug: GK01 Injection

Interventions

GK01 InjectionDRUG

Autologous tumor-reactive T cells injection

GK01 injection

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

RECRUITING

Central Study Contacts

Jihui Hao

CONTACT

+86-02223340123haojihui@tjmuch.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2025

First Posted

May 1, 2025

Study Start

March 18, 2025

Primary Completion (Estimated)

March 18, 2028

Study Completion (Estimated)

July 18, 2028

Last Updated

May 1, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)