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NCT06361927 Clinical Trial

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

NSCLC Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06361927
Other study ID # SSGJ-707-NSCLC-II-01
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date May 2024
Est. completion date July 2025

Study information
Verified date April 2024
Source Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Contact Lin Wu, MD, Ph.D
Phone 0731-89762302
Email wulin-calf@vip.163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date July 2025
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• SSGJ-707
bispecific antibody

Locations
Country Name City State
China The Hunan Cancer Hospital Changsha Hunan

Sponsors (1)
Lead Sponsor Collaborator
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary ORR Objective response rate 12 months
Secondary Safety and tolerability Safety and tolerability assessed by incidence and severity of adverse events 12 months
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