Trials / Active Not Recruiting
Active Not RecruitingNCT06373406
A Study of MHB036C for Advanced Solid Tumor
A Phase I/II, Dose Escalation and Dose Expansion Study of MHB036C for Advanced Solid Tumor to Evaluate the Tolerability/Safety, Pharmacokinetics and Efficacy
- Status
- Active Not 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
Phase I/II, dose escalation and dose expansion study to evaluate the efficacy and safety of MHB036C 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 MHB036C in patients with advanced solid tumor. The Phase I stage is to determine the maximum tolerated dose (MTD). The phase II stage is to determine the recommended Phase 2 dose (RP2D) according to safety and efficacy in specific tumor types.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MHB036C | An antibody-drug conjugate therapy |
Timeline
- Start date
- 2023-05-26
- Primary completion
- 2025-12-01
- Completion
- 2026-12-01
- First posted
- 2024-04-18
- Last updated
- 2025-11-19
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06373406. Inclusion in this directory is not an endorsement.