NCT07130383

A Study of MHB036C Combined With MHB039A in Patients With Advanced Breast Cancer or Other Advanced Malignant Solid Tumors

An Open-label Phase II Clinical Study of MHB036C for Injection Combined With MHB039A for Injection in Patients With Advanced Breast Cancer or Other Advanced Malignant Solid Tumors

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicenter Phase II study of MHB036C combined with MHB039A in patients with advanced Breast Cancer or other advanced malignant solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of MHB036C and MHB039A combination therapy.

Detailed description

This phase II clinical trial of MHB036C and MHB039A combination therapy comprises two parts: a safety run-in phase and an indication expansion phase. The safety run-in phase includes a dose escalation part and an optional PK expansion part. The primary objectives are to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of MHB036C combined with MHB039A in patients with advanced solid tumors. The optional PK expansion part is allowed to enroll additional patients at any non-DLT dose levels that have completed DLT (dose-limiting toxicity) evaluation. Based on the safety, PK, and preliminary efficacy data from the safety run-in phase, the sponsor will initiate the indication expansion phase at selected dose levels. This phase is an open-label, multicenter, multi-cohort study designed to further evaluate the efficacy and safety of MHB036C and MHB039A combination therapy in patients with advanced breast cancer and other specific types of advanced solid tumors.

Conditions

• Advanced Breast Cancer
• Advanced Malignant Solid Tumor

Interventions

Type	Name	Description
DRUG	MHB036C for Injection	Intravenous administration
DRUG	MHB039A for Injection	Intravenous administration

Timeline

• Start date: 2025-09-30
• Primary completion: 2029-08-01
• Completion: 2031-08-01
• First posted: 2025-08-19
• Last updated: 2025-11-18

Locations

1 site across 1 country: China