Trials / Active Not Recruiting
Active Not RecruitingNCT06345482
A Study of MHB039A for Advanced Solid Tumor
A Phase I/II Study of MHB039A for Advanced Solid Tumor to Evaluate the Efficacy and Safety
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 196 (estimated)
- Sponsor
- Minghui Pharmaceutical (Hangzhou) Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Phase I/II open label, multicenter study to evaluate the efficacy and safety of MHB039A in advanced malignant tumors.
Detailed description
This first-in-human, dose escalation and dose expansion study is to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of MHB039A in patients with advanced solid tumor. The Phase I stage （dose escalation）is to determine the maximum tolerated dose (MTD). The phase II stage （dose expansion）is to determine the recommended Phase 2 dose (RP2D) according to safety and efficacy in specific tumor types.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MHB039A | a bispecific antibody |
Timeline
- Start date
- 2024-04-16
- Primary completion
- 2028-04-01
- Completion
- 2029-06-01
- First posted
- 2024-04-03
- Last updated
- 2025-11-20
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06345482. Inclusion in this directory is not an endorsement.