This study was designed to compare the efficacy and safety of MHB088C for Injection with treatment of physician's choice (TPC) in participants with relapsed small cell lung cancer (SCLC).
The primary objective of this study is to assess whether treatment with MHB088C for Injection improves prolongs overall survival (OS) compared with treatment of physician's choice among participants with relapsed SCLC. The secondary objectives of the study are to further evaluate the efficacy/safety of MHB088C for Injection, immunogenicity of MHB088C, and characterize the pharmacokinetics of MHB088C.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
450
2 mg/kg intravenous dose on Day 1 and Day 15 of each 28-day cycle
1.25 mg/m\^2 intravenous dose on Day 1 to Day 5 of each 21-day cycle
65 mg/m\^2 intravenous dose on Day 1 and Day 8 of each 21-day cycle
Shanghai East Hospital
Shanghai, China
RECRUITINGOverall Survival
Time frame: From the date of randomization to the date of death due to any cause, up to approximately 5 years
Number of Participants With Objective Response Rate Assessed by Investigator
Confirmed objective response rate (ORR) is defined as the sum of the complete response (CR) rate and partial response (PR) rate based on investigator by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
Time frame: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years
Progression-free Survival As Assessed by Investigator
PFS is defined as the time interval from the date of randomization to the date of disease progression as per investigator assessment or death due to any cause.
Time frame: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years
Duration of Response As Assessed by Investigator
Duration of response (DoR) is defined as the time from the date of the first documentation of objective response (complete response \[CR\] or partial response \[PR\]) to the date of the first documentation of progressive disease (PD) or death. The DoR will be calculated for responding participants (PR or CR) only.
Time frame: From the date of first documentation of confirmed response (CR or PR) to the first documentation of objective progression or to death due to any cause, whichever occurs first, up to approximately 5 years
Disease Control Rate As Assessed by Investigator
Disease control rate is defined as the proportion of participants who have achieved a best overall response of confirmed CR, confirmed PR, or SD (or non-CR/non-PD) by investigator assessment per RECIST v1.1.
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135 mg/m\^2 intravenous dose on Day 1 of each 21-day cycle
Time frame: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years
Incidence and severity of adverse events (AEs), serious adverse events (SAEs), AEs leading to treatment interruption, and AEs leading to treatment discontinuation.
Assessed based on NCI CTCAE v5.0
Time frame: Baseline up to 5 years
Pharmacokinetic Parameter Maximum Concentration for MHB088C, Total Anti-B7-H3 Antibody, and MH30010008
Maximum concentration (Cmax) will be assessed using non-compartmental methods in participants randomized to the MHB088C group.
Time frame: Day 1 and 15 of Cycle 1 before infusion (BI), end of infusion (EOI), and 5 hours after completion of infusion; Day 1 of Cycle 2 to Cycle 5, BI and EOI; Day 1 of Cycle 6 and every 3 cycles thereafter up to 5 years and EOT visit, BI (each cycle is 28 days)
Pharmacokinetic Parameter Time to Maximum Concentration for MHB088C, Total Anti-B7-H3 Antibody, and MH30010008
Pharmacokinetic Parameter Time to Maximum Concentration for MHB088C, Total Anti-B7-H3 Antibody, and MH30010008.
Time frame: Day 1 and 15 of Cycle 1 before infusion (BI), end of infusion (EOI), and 5 hours after completion of infusion; Day 1 of Cycle 2 to Cycle 5, BI and EOI; Day 1 of Cycle 6 and every 3 cycles thereafter up to 5 years and EOT visit, BI (each cycle is 28 days)