MHB118C injection for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human, open-label Phase 1 trial of MHB118C given as monotherapy to adults with advanced solid tumors. The study begins with a multicenter dose-escalation phase to determine safety, tolerability, pharmacokinetics, dose-limiting toxicities, and the maximum tolerated dose, including PK expansion cohorts at selected dose levels. If safety, PK, and early efficacy signals are acceptable, the sponsor will open indication-specific expansion cohorts to further explore safety and preliminary antitumor activity in particular tumor types. Participants must have measurable disease and adequate organ function and be refractory to or intolerant of standard therapies.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shanghai Chest Hospital
  Shanghai, China Recruiting

Study contacts

• Study coordinator: VP of R&D
• Email: jwshi@minghuipharma.com
• Phone: 86 0571-86963293

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.