RecruitingPhase 1Phase 2NCT07192120

A Study of MHB048C in Patients With Advanced Solid Tumors

A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MHB048C for Injection in Patients With Advanced Solid Tumors


Sponsor

Minghui Pharmaceutical (Hangzhou) Ltd

Enrollment

200 participants

Start Date

Jan 16, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This is a first-in-human, open-label, multicenter Phase I/II study of MHB048C in patients with advanced solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB048C monotherapy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called MHB048C for adults with advanced solid tumors (any type) that have not responded to standard treatments. This is an early-phase study focused on safety and finding the right dose. **You may be eligible if...** - You are 18 or older - You have a confirmed advanced solid tumor that has stopped responding to standard therapy, that you could not tolerate, or for which no standard treatment exists - You have at least one measurable tumor on imaging - You are well enough to participate (ECOG 0 or 1) - Your life expectancy is at least 3 months - Your blood counts and organ function are adequate **You may NOT be eligible if...** - You have had two or more separate cancers within the past 5 years - You recently received chemotherapy (within 3 weeks) or other cancer therapy (within 4 weeks) - You have brain, bone marrow, or spinal cord involvement from cancer - You have had recent vaccinations, serious infections, or significant bleeding - You are pregnant or breastfeeding - You have serious heart, lung, or cardiovascular disease - You have a known allergy to the study drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMHB048C for Injection

IV administration of MHB048C Q2W or Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT07192120


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