A Phase II Study of SSGJ-707 Monotherapy in First-line PD... | NCT06361927

Studies
A Phase II Study of SSGJ-707 Monotherapy in First-line PD-L1 Positive Advanced NSCLC Patients

NCT06361927

Sponsor

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Status

Unknown status

Last Update Posted

May 16, 2024Actual

Enrollment

120Estimated

Phase

Phase 2

Conditions

NSCLC

Interventions

SSGJ-707

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

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2024Actual

Primary Completion Date

Jun 2025Estimated

Completion Date

Jul 2025Estimated

First Submitted Date

Apr 8, 2024

First Submission Date that Met QC Criteria

Apr 8, 2024

First Posted Date

Apr 12, 2024Actual

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 14, 2024

Last Update Posted Date

May 16, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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 includes two cohorts, cohort A is for non-squamous NSCLC and cohort B is for squamous NSCLC.

Detailed Description

This study is a study of SSGJ-707 monotherapy in First-line PD-L1 Positive advanced NSCLC Patients. This study includes two cohorts, cohort A is for non-squamous NSCLC and cohort B is for squamous NSCLC. Each cohort will assess the efficacy and safety of the preset several dose levels of SSGJ-707 in advanced NSCLC Patients.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cohort A：dose level 1 of SSGJ-707	Experimental		Drug: SSGJ-707
cohort A：dose level 2 of SSGJ-707	Experimental		Drug: SSGJ-707
cohort A：dose level 3 of SSGJ-707	Experimental		Drug: SSGJ-707
cohort B：dose level 1 of SSGJ-707	Experimental		Drug: SSGJ-707
cohort B：dose level 2 of SSGJ-707	Experimental	cohort B	Drug: SSGJ-707
cohort B：dose level 3 of SSGJ-707	Experimental		Drug: SSGJ-707

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SSGJ-707	Drug	bispecific antibody	cohort A：dose level 1 of SSGJ-707 cohort A：dose level 2 of SSGJ-707 cohort A：dose level 3 of SSGJ-707

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ORR	Objective response rate	12 months

Secondary Outcomes

Measure	Description	Time Frame
Safety and tolerability	Safety and tolerability assessed by incidence and severity of adverse events	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males and/or females over age 18
Histologically and/or cytologically documented local advanced or metastatic NSCLC .
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Expected survival >=3 months.
Signed informed consent form.

Exclusion Criteria:

Known uncontrolled or symptomatic central nervous system metastatic disease.
Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade >1 (National Cancer Institute Common terminology Criteria [NCI CTCAE] v.5.0).
Inadequate organ or bone marrow function.
Pregnant or breast-feeding woman.
Known allergies, hypersensitivity, or intolerance to SSGJ-707. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lin Wu, MD, Ph.D	Contact	0731-89762302		wulin-calf@vip.163.com

Overall Officials

Name	Affiliation	Role
Lin Wu, MD, Ph.D	The Hunan Cancer Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Hunan Cancer Hospital	Recruiting	Changsha	Hunan		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