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RECRUITINGPHASE2

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

NCT06361927•Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

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

Exclusion Criteria

•1. Known uncontrolled or symptomatic central nervous system metastatic disease.
•2. 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).
•3. Inadequate organ or bone marrow function.
•4. Pregnant or breast-feeding woman.
•5. 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.

Locations (1)

The Hunan Cancer Hospital

Changsha, Hunan, China

Key Dates

Start Date

May 15, 2024

Primary Completion Date

June 1, 2025

Completion Date

July 1, 2025

Last Updated

May 16, 2024

Enrollment

120

ESTIMATED participants

Conditions

NSCLC

Interventions

SSGJ-707

DRUG

Contacts

Lin Wu, MD, Ph.D

CONTACT

0731-89762302 wulin-calf@vip.163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 16, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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

Inclusion Criteria

Exclusion Criteria

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