A Study of MHB118C Injection in Patients With Advanced Solid Tumors

NCT07045454 | Recruiting Phase 1

• 1 other identifier: MHB118C-A-101
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Malignant Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Dose-Limiting Toxicity (DLT) for MHB118C

  DLTs will be assessed during the dose-escalation phase and are defined as toxicities related to MHB118C

  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.

  Up to day 21 from the first dose

Secondary Outcomes (8)

• Incidence and severity of adverse events (AEs)

  Baseline up to 5 years

• Pharmacokinetic (PK) parameters of total antibody, ADC, and free toxin at various time points

  Baseline up to 5 years

• Immunogenicity

  Baseline up to 5 years

• ORR determined by investigators according to RECIST v1.1

  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

  Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years

Study Arms (1)

MHB118C for Injection

EXPERIMENTAL

MHB118C for Injection Q3W

Drug: MHB118C for Injection

Interventions

MHB118C for Injection DRUG

IV administration by Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.

MHB118C for Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minghui Pharmaceutical (Hangzhou) Ltd: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, China

RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

VP of R&D

CONTACT

86 0571-86963293; jwshi@minghuipharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2025
• First Posted: July 1, 2025
• Study Start: March 31, 2025
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2031
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)