MHB046C injection for adults with 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 first-in-human, open-label Phase I/II study gives MHB046C to adults with advanced solid tumors to define safety, tolerability, pharmacokinetics, and look for early signs of antitumor activity. The Phase I dose-escalation uses DLT-guided cohorts and PK expansion cohorts at dose levels that complete DLT evaluation to determine the maximum tolerated dose. Based on safety, PK, and preliminary efficacy from those cohorts, the sponsor will open a multi-cohort indication expansion phase to further evaluate activity in specific tumor types. Tumor response will be measured by RECIST v1.1 and adverse events recorded per standard criteria.

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 (unless asymptomatic, no edema, stable ≥4 weeks without steroids), 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. Uncontrolled diabetes, including ketoacidosis or hyperosmolar state within 6 months.
9. Significant bleeding, bleeding tendency, or non-healing wounds within 1 month before first dose.
10. Known hypersensitivity or delayed allergic reaction to the investigational product or its components.
11. Drug abuse or other medical/psychiatric condition that may interfere with study participation or results.
12. Known alcohol or drug dependence.
13. Pregnant or breastfeeding women, or individuals planning to conceive.

Where it's running

• Guangdong Provincial People's Hospital
  Guangzhou, Guangdong, 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.