A Study of MHB046C Injection in Patients With Advanced Solid Tumors

NCT ID: NCT06985355

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-17
• Study Completion Date: 2031-05-31

Brief Summary

This is a first-in-human, open-label, multicenter Phase I/II study of MHB046C in patients with advanced solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB046C monotherapy.

Detailed Description

This first-in-human clinical trial of MHB046C comprises two parts: a dose escalation phase and an indication expansion phase. The dose escalation phase is an open-label, multicenter study including dose escalation and PK expansion cohorts. The primary objectives are to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of MHB046C in patients with advanced solid tumors, and to determine the maximum tolerated dose (MTD). In this phase, additional patients may be enrolled in the PK expansion part at dose levels that have completed DLT (dose-limiting toxicity) evaluation.

Based on the safety, PK, and preliminary efficacy data from the completed DLT-evaluated dose levels, the sponsor will initiate the indication expansion phase. This phase is an open-label, multicenter, multi-cohort study designed to further evaluate the safety and efficacy of MHB046C monotherapy in patients with specific types of advanced solid tumors.

Conditions

Advanced Solid Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MHB046C (Phase I: Dose escalation)

There are six escalating dose cohorts.

Group Type: EXPERIMENTAL

MHB046C

Intervention Type: DRUG

IV administration of MHB046C Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.

MHB046C (Phase II: Dose expansion)

The recommended dose from the dose-escalation stage and other potential doses will be further explored.

Group Type: EXPERIMENTAL

MHB046C

Intervention Type: DRUG

IV administration of MHB046C Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.

Interventions

MHB046C

IV administration of MHB046C Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Minghui Pharmaceutical (Hangzhou) Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

VP of R&D

Role: CONTACT

jwshi@minghuipharma.com

86 0571-86963293

Facility Contacts

Ethics Committee

Role: primary

gdghospital_ec@gdph.org.cn

+86 20 8382 7812

Other Identifiers

MHB046C-A-101

Identifier Type: -

Identifier Source: org_study_id