This is a first-in-human, open-label, multicenter Phase I/II study of MHB036C combined with MHB039A or other anti-tumor therapy in patients with advanced lung cancer. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB036C combined with MHB039A or other anti-tumor therapies.
Voluntarily agrees to participate in the study and signs the informed consent form.
Age ≥ 18 years and≤75 years, no restriction on gender.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Estimated life expectancy ≥ 3 months.
Small cell lung cancer (SCLC) components in the histopathology.
History of ≥2 primary malignancies within 5 years prior to informed consent.
Received chemotherapy within 3 weeks, radiotherapy within 4 weeks, or biologic, endocrine, or immunotherapy within 4 weeks before first study dose.
Medication of other unmarketed investigational drugs or therapies within 4 weeks before dosing.
Sequential
MHB036C for Injection
DrugIV administration; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.
MHB039A for Injection
DrugIV administration; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.
Furmonertinib
DrugOral administration; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.
Carboplatin
DrugIV administration; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.
6
Treatment groupsSee each treatment group below.
(Dose-Escalation Stage): Maximum tolerated dose (MTD) for MHB036C and other anti-tumor treatment combination therapy
To determine the MTD for further evaluation of MHB036C and other anti-tumor treatment combination therapy
(Dose-Escalation Stage): Incidence and severity of adverse events (AEs)
AE assessed by investigator exclusively related to subject's underlying disease or medical condition \[graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0\].
(Dose-Expansion Stage): Objective tumor response (ORR) determined by investigators according to RECIST v1.1
Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). ORR is evaluated by the number of participants with best overall response of CR and PR (Confirmed CR/PR assessment require at least 1 repeat).
Pharmacokinetic (PK) parameters of total antibody, ADC, and free toxin at various time points
The PK parameters at different time points include: Area Under the Concentration-Time Curve (AUC)
Pharmacokinetic (PK) parameters of total antibody, ADC, and free toxin at various time points
The PK parameters at different time points include: Maximum Plasma Concentration (Cmax)
Duration of response (DOR) determined by investigators according to RECIST v1.1
DoR was defined as the period from the first occurrence of CR or PR to PD or death from any cause. If no PD or death after CR/PR, the cut-off date of progression-free survival (PFS) would be used \[Confirmed CR/PR assessment require at least one repeat (≥4 weeks)\].
Disease control rate (DCR) determined by investigators according to RECIST v1.1
Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). DCR was evaluated by the number of participants with best overall response of CR, PR and stable disease (SD) \[Confirmed CR/PR assessment require at least one repeat (≥4 weeks); SD shall be assessed at least 5 weeks after the first dose\].
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