A Study of MHB009C in Patients With Advanced Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
MHB009C for Injection: IV administration of MHB009C Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.
Study summary
This is a first-in-human, open-label, multicenter Phase I/II study of MHB009C in patients with advanced solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB009C monotherapy.
Eligibility
Primary outcome measure(s)
- (Dose-Escalation Stage): Dose-Limiting Toxicity (DLT) and Maximum tolerated dose (MTD) for MHB009C — Up to day 21 from the first dose.
To determine the MTD for further evaluation of IV administration of MHB009C monotherapy in subjects with advanced solid tumors. - (Dose-Expansion Stage): Objective tumor response (ORR) determined by investigators according to RECIST v1.1 — Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years
To determine the recommended Phase II dose (RP2D) of MHB009C for the treatment of selected patients with advanced solid tumors based on the safety and efficacy results from all enrolled subjects.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center, Shanghai | Shanghai | Shanghai Municipality | Recruiting |
More Minghui Pharmaceutical (Hangzhou) Ltd trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07326488 on ClinicalTrials.gov ↗ ← All trials in China