MHB009C for adults with advanced solid tumors

A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MHB009C for Injection in Patients With Advanced Solid Tumors

This trial will try MHB009C, an experimental injectable drug, in adults with advanced solid tumors who have no standard treatment options.

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: NCT07326488 on ClinicalTrials.gov

What this trial studies

This is a first-in-human, open-label Phase 1/2 trial of MHB009C given as monotherapy to adults with advanced solid tumors. The trial starts with a dose-escalation phase including dose-limiting toxicity (DLT) evaluation and PK expansion cohorts to define safety, tolerability, pharmacokinetics, and the maximum tolerated dose. Based on those data, a multicohort dose-expansion phase will open to further study safety and preliminary antitumor activity in selected tumor types. Patients must have measurable disease and adequate organ and marrow function to enroll.

Who should consider this trial

Good fit: Adults (≥18) with histologically or cytologically confirmed advanced solid tumors refractory to or intolerant of standard therapy, ECOG 0–1, at least one measurable lesion per RECIST v1.1, and adequate organ and marrow function are ideal candidates.

Not a fit: Patients with active brain metastases or bone marrow metastases, recent chemotherapy/radiation/other investigational treatments within required washout periods, poor organ function, or ECOG >1 are unlikely to qualify or benefit.

Why it matters

Potential benefit: If successful, MHB009C could offer a new option that stabilizes or shrinks tumors for some patients with advanced solid cancers who have exhausted standard therapies.

How similar studies have performed: Dose-escalation followed by expansion cohorts is a common first-in-human design that has led to approved oncology drugs, but MHB009C itself is untested 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, Shanghai Municipality, China (Recruiting)

Study contacts

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

Conditions Advanced Malignant Solid Tumor