MHB048C treatment for advanced solid tumors, including metastatic castration‑resistant prostate cancer

A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MHB048C for Injection in Patients With Advanced Solid Tumors

This study will test whether the experimental drug MHB048C is safe and shows signs of benefit in adults with advanced solid tumors, including metastatic castration‑resistant prostate cancer.

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 (Shanghai, Shanghai Municipality)
• Trial ID: NCT07192120 on ClinicalTrials.gov

What this trial studies

This first‑in‑human, open‑label, multicenter Phase 1/2 program gives MHB048C as monotherapy using a dose‑escalation phase to define dose‑limiting toxicity and the maximum tolerated dose, followed by a dose‑expansion phase to further examine safety and preliminary efficacy in selected cohorts such as mCRPC. Key endpoints include safety, tolerability, pharmacokinetics, and early antitumor activity measured by RECIST v1.1 and supported by PK data. Eligible patients are adults with advanced solid tumors refractory or intolerant to standard therapy with ECOG 0–1 and at least one measurable lesion or bone lesion. The protocol excludes patients with recent anticancer treatments, active brain metastases, or significant marrow compromise.

Who should consider this trial

Good fit: Adults (≥18) with histologically confirmed advanced solid tumors refractory to or without standard options, ECOG 0–1, life expectancy ≥3 months, and at least one measurable lesion are ideal candidates.

Not a fit: Patients with active brain metastases, bone marrow metastases, or who have had recent chemotherapy, radiotherapy, or other investigational agents are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, MHB048C could provide a new treatment option that helps control tumor growth in patients with advanced solid tumors including mCRPC.

How similar studies have performed: First‑in‑human programs of novel targeted agents in advanced solid tumors have occasionally shown promising activity, but MHB048C itself has not yet been tested in humans.

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

Shanghai, Shanghai Municipality

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

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

Conditions mCRPC; Advanced Malignant Solid Tumor