MHB046C injection for adults with advanced solid tumors

A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MHB046C Injection in Patients With Advanced Solid Tumors

This study will test whether MHB046C injections are safe and might shrink or control advanced solid tumors in adults 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)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06985355 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18 years) with histologically or cytologically confirmed advanced solid tumors, ECOG performance status 0–1, at least one measurable lesion by RECIST v1.1, adequate organ function, and who are refractory to or have no standard treatment options.

Not a fit: Patients with uncontrolled brain metastases, ECOG >1, very recent chemotherapy/radiation/biologic therapy, or multiple recent primary malignancies are excluded and are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, MHB046C could become a new option to control tumor growth for people with advanced solid cancers who lack effective standard therapies.

How similar studies have performed: MHB046C is being tested in humans for the first time and is therefore unproven, although other early-phase targeted and immunotherapy agents have shown responses in similar Phase I/II dose-escalation and expansion designs.

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 (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 this trial is running

Guangzhou, Guangdong

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

Study contacts

• Study coordinator: VP of R&D

Conditions: Advanced Solid Cancer