A Phase II Study of SSGJ-706 Monotherapy and Combination Therapy in Advanced Non-Small Cell Lung Cancer（NSCLC） Patients
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Objective response rate (ORR)
Overview
Brief Summary
This study includes two parts, part 1 is SSGJ-706 monotherapy therapy for advanced NSCLC and part 2 is SSGJ-706 combination therapy for advanced NSCLC
Detailed Description
This study is a study of SSGJ-706 monotherapy and combination therapy for advanced NSCLC Patients. This study includes two parts, part 1 is SSGJ-706 monotherapy therapy for advanced NSCLC and part 2 is SSGJ-706 combination therapy for advanced NSCLC. Each part will assess the efficacy and safety of the preset several dose levels of SSGJ-706 in advanced NSCLC Patients.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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-
- •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-706
- •The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Arms & Interventions
dose level 1 of SSGJ-706 monotherapy
Intervention: SSGJ-706 (Drug)
dose level 2 of SSGJ-706 monotherapy
Intervention: SSGJ-706 (Drug)
dose level 1 of SSGJ-706 combined with chemotherapy
Intervention: SSGJ-706 (Drug)
dose level 1 of SSGJ-706 combined with chemotherapy
Intervention: pemetrexed /carboplatin (Drug)
dose level 2 of SSGJ-706 combined with chemotherapy
Intervention: SSGJ-706 (Drug)
dose level 2 of SSGJ-706 combined with chemotherapy
Intervention: Carboplatin/Paclitaxel (Drug)
PD-1/L1 combined with chemotherapy
Intervention: PD-1 Inhibitor + Chemotherapy (Drug)
Outcomes
Primary Outcomes
Objective response rate (ORR)
Time Frame: 12 months
Incidence and severity of Adverse Events
Time Frame: 12 months
Secondary Outcomes
- DCR : Disease Control Rate(12 months)
- PFS：Progression-Free Survival(24 month)
- OS：Overall Survival(24 month)
- The blood concentration of SSGJ-706(Approximately 6 months)
- The incidence of Anti-drug antibody(ADA) and Neutralizing antibody(Nab)(Approximately 6 months)