This is an open-label, multi-cohort, multicenter Phase Ib/II clinical study designed to evaluate the safety, tolerability, and efficacy of SYS6090 injection in combination with chemotherapy or chemotherapy and bevacizumab or SYS6010 (an EGFR ADC) in participants with advanced lung cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
596
In this group, participants will receive SYS6090 in combination with pemetrexed and platinum-based chemotherapy.
In this group, participants will receive SYS6090 in combination with paclitaxel and platinum-based chemotherapy.
In this group, participants will receive SYS6090 in combination with docetaxel.
Dose-Limiting Toxicity (DLT) (Phase Ib)
To evaluate the safety of SYS6090 in participants.
Time frame: Approximately 21 days.
Adverse Events (AEs) (Phase Ib)
To evaluate the safety of SYS6090 combination therapy in participants.
Time frame: Up to 90 days after the last administration
Objective response rate (ORR) (Phase II)
ORR is defined as the proportion of participants in whom a complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 is observed as best overall response.
Time frame: Through out the study (up to 2 years)
Cmax of SYS6090 (and SYS6010 if applicable)
To evaluate the systemic pharmacokinetics of SYS6090 (and SYS6010 if applicable).
Time frame: Through out the study (up to 2 years)
AUC0-t of SYS6090 (and SYS6010 if applicable)
To evaluate the systemic pharmacokinetics of SYS6090 (and SYS6010 if applicable)
Time frame: Through out the study (up to 2 years)
Clearance (CL) of SYS6090 (and SYS6010 if applicable)
To evaluate the systemic pharmacokinetics of SYS6090 (and SYS6010 if applicable)
Time frame: Through out the study (up to 2 years)
Other Efficacy Endpoints Assessed by RECIST v1.1 (DoR, DCR, TTR, PFS, and OS)
Evaluation of other efficacy endpoints of SYS6090 combination therapy in participants with advanced lung cancer, assessed by the investigator according to RECIST v1.1, including duration of response (DoR), disease control rate (DCR), time to response (TTR), progression-free survival (PFS), and overall survival (OS).
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In this group, participants will receive SYS6090 in combination with pemetrexed, bevacizumab, and platinum-based chemotherapy
In this group, participants will receive SYS6090 and SYS6010.
In this group, participants will receive SYS6090 in combination with etoposide and platinum-based chemotherapy.
In this group, participants will receive SYS6090 in combination with chemotherapy or other anticancer therapies.
Time frame: Through out the study (up to 2 years)
Adverse Events (AEs) (Phase II)
To evaluate the safety of SYS6090 combination therapy in participants
Time frame: Through out the study (up to 2 years)
Correlation between Biomarker Levels and Preliminary Efficacy
The Correlation between Baseline PD-L1 Expression and Antitumor Activity
Time frame: Through out the study (up to 2 years)