MHB118C injection for advanced solid tumors

A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MHB118C Injection in Patients With Advanced Solid Tumors

This trial tests whether MHB118C injection is safe and shows signs of benefit in adults with advanced solid tumors who have exhausted standard treatment options.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd (industry)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Shanghai)
• Trial ID: NCT07045454 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18 or older with histologically or cytologically confirmed advanced solid tumors, ECOG performance status 0–1, at least one measurable lesion, adequate organ function, and who are refractory to, intolerant of, or without standard treatment options.

Not a fit: Patients with poor performance status, active brain metastases or leptomeningeal disease, recent systemic or radiotherapy within protocol-specified washouts, or multiple recent primary malignancies are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, MHB118C could provide a new treatment option that slows tumor growth or extends survival for some patients with advanced solid tumors.

How similar studies have performed: This is a first-in-human trial so MHB118C has not been tested in people yet, although some other early-phase targeted or biologic agents for solid tumors have shown promising signals in Phase 1.

Eligibility criteria

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 this trial is running

Shanghai

• Shanghai Chest Hospital — Shanghai, China (RECRUITING)

Study contacts

• Study coordinator: VP of R&D

Conditions: Advanced Malignant Solid Tumor