A Study of GFS101A in Combination With Toripalimab in Pat... | NCT05165849

Studies
A Study of GFS101A in Combination With Toripalimab in Patients With Advanced Solid Tumors

NCT05165849

Sponsor

Zhejiang Genfleet Therapeutics Co., Ltd.

Status

Withdrawn

Last Update Posted

May 20, 2022Actual

Enrollment

0Actual

Phase

Phase 1Phase 2

Conditions

Solid Tumor

Interventions

GFS101A
Toripalimab

Countries

Not provided

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

May 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

sponsor decided to withdraw the study

Expanded Access Info

Start Date

Apr 2022Estimated

Primary Completion Date

May 11, 2022Actual

Completion Date

May 11, 2022Actual

First Submitted Date

Dec 6, 2021

First Submission Date that Met QC Criteria

Dec 16, 2021

First Posted Date

Dec 21, 2021Actual

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

May 16, 2022

Last Update Posted Date

May 20, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

The purpose of this study is to evaluate the safety/tolerability, pharmacokinetics, and efficacy of GFS101A in combination with Toripalimab 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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GFS101A+Toripalimab	Experimental	Patient will be administrated with GFS101A IV in combination with Toripalimab IV. The duration of the treatment cycle is defined as 21 days.	Drug: GFS101A Drug: Toripalimab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GFS101A	Drug	GFS101A will be administrated intravenously Q3W.	GFS101A+Toripalimab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Phase I：Incidence of dose limiting toxicity (DLT) events		21days
Phase II: Overall response rate (ORR) per RECIST 1.1		approximately 12 months after first dose

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Voluntarily participate in this clinical trial, and are willing to sign informed consent forms.
Male or female aged from 18-75 years old (inclusive).
Diagnosed with histologically or cytologically confirmed advanced solid tumors.
Evaluable lesions defined by RECIST v1.1.
Eastern Cooperative Oncology Group performance status of 0 to 1.
Subjects or their legal representatives are able to communicate well with Investigators and are willing to comply with the protocol and complete the study.

Exclusion Criteria:

With clinically significant cardiac diseases
With clinically significant digestive disorders.
Other severe disease.
Pregnant or lactating women.
Other unfavorable situations for subjects to participate in the study judged by Investigators.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000656314	toripalimab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided