MHB042C for people with advanced solid tumors

A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MHB042C for Injection in Patients With Advanced Solid Tumors

This study will try MHB042C injections in adults whose advanced solid tumors have stopped responding to standard treatments.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07192107 on ClinicalTrials.gov

What this trial studies

This first-in-human, open-label Phase 1/2 trial gives MHB042C by injection to adults with advanced solid tumors and includes a dose-escalation stage followed by dose-expansion cohorts. The dose-escalation phase will determine safety, tolerability, pharmacokinetics, and the maximum tolerated dose, with a PK expansion at selected dose levels. The dose-expansion phase will enroll multiple tumor-specific cohorts to further characterize safety and preliminary antitumor activity. Key endpoints include dose-limiting toxicities, adverse events, pharmacokinetic profiles, and objective tumor responses per RECIST v1.1.

Who should consider this trial

Good fit: Adults (≥18 years) with histologically confirmed advanced solid tumors refractory or intolerant to standard therapy, ECOG performance status 0–1, life expectancy ≥3 months, at least one measurable lesion, and adequate organ and bone marrow function.

Not a fit: Patients with active brain metastases, bone marrow metastases, or who recently received chemotherapy, radiotherapy, immunotherapy, or other investigational agents are excluded and are unlikely to benefit from participating.

Why it matters

Potential benefit: If successful, MHB042C could provide a new option that stabilizes or shrinks tumors for patients with advanced solid tumors who have exhausted standard therapies.

How similar studies have performed: This is a first-in-human trial, so MHB042C has not yet been tested in people and no clinical efficacy data are available for this agent.

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. Histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy, intolerant to standard therapy, or have no standard treatment options.
6. At least one measurable lesion per RECIST v1.1 criteria or one bone.
7. Adequate bone marrow reserve and 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, or biologic, endocrine, or immunotherapy within 4 weeks before first study dose.
3. Medication of other unmarketed investigational drugs or therapies within 4 weeks before the first dose of investigational drug.
4. Brain metastases, bone marrow metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression.
5. Severe bone damage caused by bone metastasis of prostate cancer.
6. Has adverse reactions from previous anti-tumor treatment that have not recovered to ≤ CTCAE 5.0 Grade 1.
7. Severe lung disease affecting pulmonary function.
8. Vaccinated within 4 weeks before dosing.
9. Active systemic infection requiring treatment within 7 days before dosing.
10. Serious cardiovascular or cerebrovascular diseases.
11. Uncontrolled third-space effusions not suitable for enrollment.
12. Significant bleeding, bleeding tendency, or non-healing wounds within 1 month before first dose.
13. Known hypersensitivity or delayed allergic reaction to the investigational product or its components.
14. Drug abuse or other medical/psychiatric condition that may interfere with study participation or results.
15. Known alcohol or drug dependence.
16. Pregnant or breastfeeding women, or individuals planning to conceive. -

Where this trial is running

Guangzhou, Guangdong

• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: CMO/ Senior Vice President of R&D

Conditions Advanced Malignant Solid Tumor