A Single-Arm, Open-Label, Phase I Study of GK01 for Advan... | NCT06954558

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

NCT06954558

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Status

Recruiting

Last Update Posted

May 1, 2025Actual

Enrollment

15Estimated

Phase

Phase 1

Conditions

Advanced Solid Tumors

Interventions

GK01 Injection

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 18, 2025Actual

Primary Completion Date

Mar 18, 2028Estimated

Completion Date

Jul 18, 2028Estimated

First Submitted Date

Apr 14, 2025

First Submission Date that Met QC Criteria

Apr 24, 2025

First Posted Date

May 1, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2025

Last Update Posted Date

May 1, 2025Actual

Name	Class
Beijing Geekgene Technology Co., LTD	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GK01 injection	Experimental	Autologous tumor-reactive T cells injection	Drug: GK01 Injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GK01 Injection	Drug	Autologous tumor-reactive T cells injection	GK01 injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and Tolerability	The incidence and severity, and correlation of AEs (Adverse Events) and SAEs (Serious Adverse Events).	2 years

Secondary Outcomes

Measure	Description	Time Frame
PK	Levels of T-cell Receptor copies	2 years
Objective response rate (ORR)		2 years
Progress-free survival(PFS)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jihui Hao	Contact	+86-02223340123		haojihui@tjmuch.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tianjin Medical University Cancer Institute & Hospital	Recruiting	Tianjin			China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided