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Trial Title:
A Phase II Study of SSGJ-707 Monotherapy in First-line PD-L1 Positive Advanced NSCLC Patients
NCT ID:
NCT06361927
Condition:
NSCLC
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SSGJ-707
Description:
bispecific antibody
Arm group label:
cohort A：dose level 1 of SSGJ-707
Arm group label:
cohort A：dose level 2 of SSGJ-707
Arm group label:
cohort A：dose level 3 of SSGJ-707
Arm group label:
cohort B：dose level 1 of SSGJ-707
Arm group label:
cohort B：dose level 2 of SSGJ-707
Arm group label:
cohort B：dose level 3 of SSGJ-707
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Hunan Cancer Hospital
Address:
City:
Changsha
Country:
China
Status:
Recruiting
Contact:
Last name:
Lin Wu, MD,Ph.D
Phone:
0731-89762302
Email:
wulin-calf@vip.163.com
Start date:
May 15, 2024
Completion date:
July 2025
Lead sponsor:
Agency:
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Agency class:
Industry
Source:
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06361927
