> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-mhb118c-injection-in-patients-with-advanced-solid-50a4cd8c-fe9c-435f-bcc1-de8451195dcb > Record changed: 2026-10-13 # A Study of MHB118C Injection in Patients With Advanced Solid Tumors NCT07045454 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07045454) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07045454) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07045454) Participants 200 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07045454) Lead sponsor Minghui Pharmaceutical (Hangzhou) Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07045454) Start date 2025-03-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07045454) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07045454) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07045454) **Short title** A Study of MHB118C Injection in Patients With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07045454) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07045454) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07045454) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07045454) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07045454) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07045454) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07045454) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07045454) ## Dates **Completion date** 2031-03-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07045454) **First posted** 2025-07-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07045454) **Registry last updated** 2025-07-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07045454) **Primary completion date** 2029-03-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07045454) **Start date** 2025-03-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07045454) ## Size and sites **Participants** 200 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07045454) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07045454) **Planned participants** 200 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07045454) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07045454) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07045454) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07045454) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07045454) **Lead sponsor** Minghui Pharmaceutical (Hangzhou) Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07045454) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07045454) ## Identifiers **Registry ID** NCT07045454 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07045454) **ClinicalTrials.gov ID** NCT07045454 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07045454) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07045454) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07045454) ## Outcomes ### Primary outcomes 1. 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 2. 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. ### Secondary outcomes 1. 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\\\]. 2. 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) 3. Immunogenicity Timeframe: Baseline up to 5 years Proportion of subjects who develop anti-MHB118C antibodies (ADA). 4. 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 . 5. 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. 6. 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). 7. 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. 8. 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. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07045454) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria 1. Voluntarily agrees to participate in the study and signs the informed consent form. 2. Age ≥ 18 years, no restriction on gender. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 4. Estimated life expectancy ≥ 3 months. 5. Able to understand and comply with the study protocol and follow-up procedures. 6. Histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy, intolerant to standard therapy, or have no standard treatment options. 7. At least one measurable lesion per RECIST v1.1 criteria. 8. Adequate organ function. ### Exclusion criteria 1. History of ≥2 primary malignancies within 5 years prior to informed consent. 2. 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. 3. Brain metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression. 4. Severe lung disease affecting pulmonary function. 5. Active systemic infection requiring treatment within 7 days before dosing. 6. Serious cardiovascular or cerebrovascular diseases 7. Uncontrolled third-space effusions not suitable for enrollment. 8. Known hypersensitivity or delayed allergic reaction to the investigational product or its components. 9. Drug abuse or other medical/psychiatric condition that may interfere with study participation or results. 10. Known alcohol or drug dependence. 11. Pregnant or breastfeeding women, or individuals planning to conceive. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07045454) ## Sites - Shanghai Chest HospitalShanghai, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07045454) ## Related records ### Drugs (1) - [Delafloxacin](https://trialight.com/data/asset/delafloxacin-70daac65-8439-49a7-b10b-4046284fc0e6.md) ### Lead sponsors (1) - [Minghui Pharmaceutical (Hangzhou) Ltd](https://trialight.com/data/company/minghui-pharmaceutical-hangzhou-ltd-1d0dd426-0d04-4cd3-9d22-81090754fcff.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. Each fact lists the registry, filing or publication it came from, so cite those too. - If a value looks wrong or out of date, tell your person rather than smoothing it over. 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