A Phase 1 interventional study of MHB118C for Injection in Advanced Malignant Solid Tumor, sponsored by Minghui Pharmaceutical (Hangzhou) Ltd. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-01.
Sponsored by Minghui Pharmaceutical (Hangzhou) Ltd · Phase 1, Interventional, and Treatment
This is a first-in-human, open-label, multicenter Phase I study of MHB118C in patients with advanced solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB118C monotherapy.
This first-in-human clinical trial of MHB118C comprises two parts: a dose escalation phase and indication expansion phase. The dose escalation phase is an open-label, multicenter study including dose escalation and PK expansion cohorts. The primary objectives are to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of MHB118C in patients with advanced solid tumors, and to determine the maximum tolerated dose (MTD). In this phase, additional patients may be enrolled in the PK expansion part at dose levels that have completed DLT (dose-limiting toxicity) evaluation.
Based on the safety, PK, and preliminary efficacy data from the completed DLT-evaluated dose levels, the sponsor will initiate the indication expansion phase. This phase is an open-label, multicenter, multi-cohort study designed to further evaluate the safety and efficacy of MHB118C monotherapy in patients with 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.
Exclusion Criteria:
MHB118C for Injection Q3W
Drug: MHB118C for Injection
IV administration by Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.
Dose-Limiting Toxicity (DLT) for MHB118C
DLTs will be assessed during the dose-escalation phase and are defined as toxicities related to MHB118C
Time frame: Up to day 21 from the first dose
Maximum tolerated dose (MTD) for MHB118C
To determine the MTD for further evaluation of IV administration of MHB118C in subjects with advanced solid tumors.
Time frame: Up to day 21 from the first dose
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 to 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: Baseline up to 5 years
Immunogenicity
Proportion of subjects who develop anti-MHB118C antibodies (ADA).
Time frame: Baseline up to 5 years
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. ORR is evaluated by the number of participants with best overall response of CR and PR .
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.
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. DCR was evaluated by the number of participants with best overall response of CR, PR and stable disease (SD).
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. 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
Plan to share: No
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Minghui Pharmaceutical (Hangzhou) Ltd