This is an open-label, multicenter Phase II study of MHB036C combined with MHB039A in patients with advanced Breast Cancer or other advanced malignant solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of MHB036C and MHB039A combination therapy.
Voluntarily agrees to participate in the study and signs the informed consent form.
Age ≥ 18 and ≤75 years, no restriction on gender.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Estimated life expectancy ≥ 3 months.
History of ≥2 primary malignancies within 5 years prior to informed consent.
Received anti-tumor treatment within 4 weeks or within the 5 half-lives of the previous treatment (whichever is shorter) before dosing.
Medication of other unmarketed investigational drugs or therapies within 4 weeks before dosing.
Undergone major organ surgery (excluding biopsy) or significant trauma within 4 weeks before dosing or requiring elective surgery during the study.
Sequential
MHB036C for Injection
DrugIntravenous administration
MHB039A for Injection
DrugIntravenous administration
7
Treatment groupsSee each treatment group below.
(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).
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) \[Confirmed CR/PR assessment require at least one repeat (≥4 weeks); SD shall be assessed at least 5 weeks after the first dose\].
Progression-free survival (PFS) 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). PFS was defined as the time from random assignment (dose expansion stage) or first dose (dose escalation stage) to PD or death from any cause.
Overall survival (OS)
OS was defined as the time from random assignment or first dose to death from any cause.
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