A Phase 2 interventional study of MHB036C for Injection and MHB039A for Injection in Advanced Breast Cancer and Advanced Malignant Solid Tumor, sponsored by Minghui Pharmaceutical (Hangzhou) Ltd. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-11-18.
Sponsored by Minghui Pharmaceutical (Hangzhou) Ltd · Phase 2, Interventional, and Treatment
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.
This phase II clinical trial of MHB036C and MHB039A combination therapy comprises two parts: a safety run-in phase and an indication expansion phase. The safety run-in phase includes a dose escalation part and an optional PK expansion part. The primary objectives are to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of MHB036C combined with MHB039A in patients with advanced solid tumors. The optional PK expansion part is allowed to enroll additional patients at any non-DLT dose levels that have completed DLT (dose-limiting toxicity) evaluation.
Based on the safety, PK, and preliminary efficacy data from the safety run-in phase, the sponsor will initiate the indication expansion phase at selected dose levels. This phase is an open-label, multicenter, multi-cohort study designed to further evaluate the efficacy and safety of MHB036C and MHB039A combination therapy in patients with advanced breast cancer and other specific types of advanced solid tumors.
Minghui Pharmaceutical (Hangzhou) Ltd is the lead sponsor of 20 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Eligible participants of childbearing potential (males and females) must agree to take highly reliable contraceptive measures with their partners during the study and within at least 12 weeks after the last dose.
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Exclusion Criteria:
Subjects will receive MHB036C Q3W in combination with MHB039A Q3W by intravenous administration.
Drug: MHB036C for Injection · Drug: MHB039A for Injection
Subjects will receive MHB036C Q3W in combination with MHB039A Q3W by intravenous administration.
Drug: MHB036C for Injection · Drug: MHB039A for Injection
Subjects will receive MHB036C Q3W in combination with MHB039A Q3W by intravenous administration.
Drug: MHB036C for Injection · Drug: MHB039A for Injection
Subjects will receive MHB036C Q3W in combination with MHB039A Q3W by intravenous administration.
Drug: MHB036C for Injection · Drug: MHB039A for Injection
Subjects will receive MHB036C Q3W in combination with MHB039A Q3W by intravenous administration.
Drug: MHB036C for Injection · Drug: MHB039A for Injection
Subjects will receive MHB036C Q3W in combination with MHB039A Q3W by intravenous administration.
Drug: MHB036C for Injection · Drug: MHB039A for Injection
Subjects will receive MHB036C Q3W in combination with MHB039A Q3W by intravenous administration.
Drug: MHB036C for Injection · Drug: MHB039A for Injection
Intravenous administration
Intravenous administration
(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).
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 (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 \[Confirmed CR/PR assessment require at least one repeat (≥4 weeks)\].
Time frame: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years
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) \[Confirmed CR/PR assessment require at least one repeat (≥4 weeks); SD shall be assessed at least 5 weeks after the first dose\].
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 (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.
Time frame: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years
Overall survival (OS)
OS was defined as the time from random assignment or first dose to death from any cause.
Time frame: Baseline up until death up to approximately 5 years
Incidence and severity of adverse events (AEs)
AE assessed by investigator exclusively related to subject's underlying disease or medical condition \[graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0\].
Time frame: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years.
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).
Time frame: From pre-dose to 22 days after the first dose
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).
Time frame: From pre-dose to 22 days after the first dose
Plan to share: No
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Minghui Pharmaceutical (Hangzhou) Ltd