A Study of MHB118C Injection in Patients With Advanced Solid Tumors
- Summary
- 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.
- Short title
- A Study of MHB118C Injection in Patients With Advanced Solid Tumors
- Official title
- A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MHB118C Injection in Patients With Advanced Solid Tumors
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2031-03-01
- First posted
- 2025-07-01
- Registry last updated
- 2025-07-01
- Primary completion date
- 2029-03-01
- Start date
- 2025-03-31
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Minghui Pharmaceutical (Hangzhou) Ltd
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07045454
- ClinicalTrials.gov ID
- NCT07045454
- Registry record
- Open registry record
- Allocation
- Not applicable
- Model
- Single group
- Purpose
- Treatment
- Masking
- No masking
Dose-Limiting Toxicity (DLT) for MHB118C
Timeframe: Up to day 21 from the first dose
DLTs will be assessed during the dose-escalation phase and are defined as toxicities related to MHB118C
Maximum tolerated dose (MTD) for MHB118C
Timeframe: Up to day 21 from the first dose
To determine the MTD for further evaluation of IV administration of MHB118C in subjects with advanced solid tumors.
Incidence and severity of adverse events (AEs)
Timeframe: Baseline up to 5 years
AE assessed by investigator exclusively related to subject's underlying disease or medical condition \[graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0\].
Pharmacokinetic (PK) parameters of total antibody, ADC, and free toxin at various time points
Timeframe: Baseline up to 5 years
The PK parameters at different time points include:Area Under the Concentration-Time Curve (AUC)
Immunogenicity
Timeframe: Baseline up to 5 years
Proportion of subjects who develop anti-MHB118C antibodies (ADA).
ORR determined by investigators according to RECIST v1.1
Timeframe: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years
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 .
Duration of response (DOR) determined by investigators according to RECIST v1.1
Timeframe: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years
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.
Disease control rate (DCR) determined by investigators according to RECIST v1.1
Timeframe: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years
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).
Progression-free survival (PFS) determined by investigators according to RECIST v1.1
Timeframe: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years
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.
Overall survival (OS)
Timeframe: Baseline up until death up to approximately 5 years
OS was defined as the time from random assignment or first dose to death from any cause.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- Voluntarily agrees to participate in the study and signs the informed consent form.
- Age ≥ 18 years, no restriction on gender.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Estimated life expectancy ≥ 3 months.
- Able to understand and comply with the study protocol and follow-up procedures.
- Histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy, intolerant to standard therapy, or have no standard treatment options.
- At least one measurable lesion per RECIST v1.1 criteria.
- Adequate organ function.
- History of ≥2 primary malignancies within 5 years prior to informed consent.
- Received chemotherapy within 3 weeks, radiotherapy within 4 weeks (2 weeks for palliative bone radiotherapy), or biologic, endocrine, or immunotherapy within 4 weeks before first study dose.
- Brain metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression.
- Severe lung disease affecting pulmonary function.
- Active systemic infection requiring treatment within 7 days before dosing.
- Serious cardiovascular or cerebrovascular diseases
- Uncontrolled third-space effusions not suitable for enrollment.
- Known hypersensitivity or delayed allergic reaction to the investigational product or its components.
- Drug abuse or other medical/psychiatric condition that may interfere with study participation or results.
- Known alcohol or drug dependence.
- Pregnant or breastfeeding women, or individuals planning to conceive.
- Shanghai Chest HospitalShanghai, ChinaRecruiting