A Study of MHB039A for Advanced Solid Tumor

Phase 1

Active, not recruiting

• Conditions: Advanced Solid Tumor
• Interventions: Drug: MHB039A

• Registration Number: NCT06345482
• Lead Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd

Brief 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.

Study Timeline

• Study First Submitted: 2024-03-18
• Study First Submitted QC: 2024-04-01
• Study First Posted: 2024-04-03
• Study Start: 2024-04-16
• Status Verified: 2025-11
• Last Update Submitted: 2025-11-17
• Last Update Posted: 2025-11-20
• Primary Completion: 2028-04-01
• Study Completion: 2029-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

• Histologically or cytologically documented advanced or metastatic solid tumor that is refractory/relapsed to standard therapies, or for which no effective standard therapy is available, or the subject refuses standard therapy.
• Written and signed informed consent
• Aged 18 years or older
• Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1
• Life expectancy >=3 months

Exclusion Criteria

• Prior malignancy active within the previous 5 years except for the tumor for which a subject is enrolled in the study, and locally curable cancers that have been apparently cured, (e.g. basal cell skin cancer, or carcinoma in situ of the cervix or others)
• Receiving any chemotherapy within 3 weeks prior to the first dose；or other systemic anticancer therapy within 4 weeks prior to the first dose
• Receiving prior anti-PD-1, anti-PD-L1, anti-CTLA(cytotoxic T-lymphocyte-associated protein)-4 or any other immunotherapy or immune-oncology (IO) agent within 28 days of first dose with MHB039A or experienced a toxicity that led to permanent discontinuation of prior immunotherapy
• Unresolved toxicities from prior anticancer therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MHB039A	MHB039A	MHB039A IV every 2 weeks or every 3 weeks (including 5mg/kg、10mg/kg、20mg/kg and 30mg/kg)

Primary Outcome Measures

Name	Time	Method
Incidence of participants with adverse events (AE)	Until 30 days after last dose of MHB039A	An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Number of participants with dose-limiting toxicity (DLT)	At the end of Cycle 1 (each cycle is 21 days for every three weeks cohort and 28 days for every two weeks cohort)	DLTs will be assessed during the dose-escalation phase and are defined as toxicities related to MHB039A which meet pre-defined severity criteria and occurs within the first cycle of treatment.

Secondary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	Until 30 days after last dose of MHB039A	The ORR is defined as the proportion of subjects with confirmed complete remission (CR) or confirmed partial response (PR), based on RECIST Version 1.1.
The area under the plasma concentration-time curve (AUC) of MHB039A	Until 30 days after last dose of MHB039A	to analysis the serum concentrations of MHB039A at different timepoints to determine the AUC of MHB039A
To detectable anti-drug antibodies with treated subjects	Until 30 days after last dose of MHB039A	The immunogenicity of MHB039A will be assessed by the number of subjects who produce anti-drug antibodies (ADAs).
Maximum Plasma Concentration (Cmax) of MHB039A	Until 30 days after last dose of MHB039A	to analysis the serum concentrations of MHB039A at different timepoints to determine the Cmax of MHB039A

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai Municipality, China