NCT07126665

A Study of MHB088C Combined With MHB039A in Patients With Advanced Malignant Solid Tumors

An Open-label Phase I/II Clinical Study of MHB088C for Injection Combined With MHB039A for Injection in Patients With Advanced Malignant Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a first-in-human, open-label, multicenter Phase I/II study of MHB088C combined with MHB039A in patients with advanced malignant solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB088C and MHB039A combination therapy.

Detailed description

This first-in-human clinical trial of MHB088C and MHB039A combination therapy comprises two parts: a dose escalation phase and 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 MHB088C combined with MHB039A in patients with advanced solid tumors, and to determine the maximum tolerated dose (MTD). 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 to further evaluate the safety and efficacy of MHB088C and MHB039A combination therapy in patients with specific types of advanced solid tumors.

Conditions

• Advanced Malignant Solid Tumor

Interventions

Type	Name	Description
DRUG	MHB088C for Injection	Intravenous administration
DRUG	MHB039A for Injection	Intravenous administration

Timeline

• Start date: 2025-09-18
• Primary completion: 2029-08-01
• Completion: 2031-08-01
• First posted: 2025-08-17
• Last updated: 2025-11-18

Locations

1 site across 1 country: China