NCT06985355

A Study of MHB046C Injection in Patients 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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 200 (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 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

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2025-07-17
• Primary completion: 2029-05-01
• Completion: 2031-05-01
• First posted: 2025-05-22
• Last updated: 2025-09-18

Locations

1 site across 1 country: China