SPGL008 in Combination With SSGJ-706 ± Chemotherapy for Advanced Non-small Cell Lung Cancer
A Phase 2 Study of SPGL008 in Combination With SSGJ-706 ± Chemotherapy for Advanced Non-small Cell Lung Cancer
1 other identifier
interventional
220
0 countries
N/A
Brief Summary
This study is an open, multicenter, phase 2 clinical trial of SPGL008 in combination with SSGJ-706 ± chemotherapy for the treatment of advanced non-small cell lung cancer. The objective is to evaluate the safety and efficacy of SPGL008 combined with SSGJ-706 in participants with driver gene-negative advanced non-small cell lung cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2026
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2026
CompletedFirst Posted
Study publicly available on registry
October 15, 2026
CompletedStudy Start
First participant enrolled
November 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
Study Completion
Last participant's last visit for all outcomes
November 1, 2029
October 15, 2026
October 1, 2026
1 year
September 20, 2026
October 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of Adverse Events(AEs) assessed by NCI-CTCAE v6.0
Collect and analyze the incidence of adverse events to evaluate safety and tolerability per NCI-CTCAE v6.0
24 months
Objective Response Rate(ORR)
The efficacy of solid tumors was evaluated according to RECIST v1.1
24 months
Secondary Outcomes (6)
Maximum Plasma Concentration (Cmax)
24 months
Area under the curve (AUC)
24months
Half-life (T1/2)
24months
Lymphocytes
24months
Immunogenicity
24months
- +1 more secondary outcomes
Study Arms (3)
SPGL0008 dose1/2+SSGJ-706 selected dose
EXPERIMENTALSPGL0008 selected dose+SSGJ-706 selected dose
EXPERIMENTALSPGL0008 selected dose+SSGJ-706 selected dose+chemotherapy
EXPERIMENTALInterventions
SSGJ-706 is a bispecific antibody that targets both human PD-1 and PD-L1
SPGL008 is a dual-functional molecule that combines an anti-B7-H3 monoclonal antibody with IL-15Rα sushi / IL-15.
Eligibility Criteria
You may qualify if:
- Males and/or females over age 18-75
- Histologically and/or cytologically documented local advanced or metastatic NSCLC .
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Expected survival \>=3 months.
- Adequate organ or bone marrow function.
- Signed informed consent form.
You may not qualify if:
- Known positive driver genes
- Pregnant or breast-feeding woman.
- Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade \>1 (National Cancer Institute Common terminology Criteria
- Known allergies, hypersensitivity, or intolerance to SSGJ-706/SPGL008 The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2026
First Posted
October 15, 2026
Study Start (Estimated)
November 1, 2026
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
November 1, 2029
Last Updated
October 15, 2026
Record last verified: 2026-10
Data Sharing
- IPD Sharing
- Will not share