A Study of MHB039A for Advanced Solid Tumor

Advanced Solid Tumor Clinical Trial

Official title:

A Phase I/II Study of MHB039A for Advanced Solid Tumor to Evaluate the Efficacy and Safety

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06345482
• Other study ID #: MHB039A-A-101
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: April 1, 2024
• Est. completion date: June 1, 2029

Study information

• Verified date: April 2024
• Source: Minghui Pharmaceutical (Hangzhou) Ltd
• Contact: Shun Lu, MD
• Phone: 13601813062
• Email: shun_lu[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase I/II open label, multicenter study to evaluate the efficacy and safety of MHB039A in advanced malignant tumors.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 196
• Est. completion date: June 1, 2029
• Est. primary completion date: April 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• MHB039A
a bispecific antibody

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Minghui Pharmaceutical (Hangzhou) Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of participants with adverse events (AE)	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.	Until 30 days after last dose of MHB039A
Primary	Number of participants with dose-limiting toxicity (DLT)	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.	At the end of Cycle 1 (each cycle is 21 days for every three weeks cohort and 28 days for every two weeks cohort)
Secondary	Maximum Plasma Concentration (Cmax) of MHB039A	to analysis the serum concentrations of MHB039A at different timepoints to determine the Cmax of MHB039A	Until 30 days after last dose of MHB039A
Secondary	The area under the plasma concentration-time curve (AUC) of MHB039A	to analysis the serum concentrations of MHB039A at different timepoints to determine the AUC of MHB039A	Until 30 days after last dose of MHB039A
Secondary	To detectable anti-drug antibodies with treated subjects	The immunogenicity of MHB039A will be assessed by the number of subjects who produce anti-drug antibodies (ADAs).	Until 30 days after last dose of MHB039A
Secondary	Objective response rate (ORR)	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.	Until 30 days after last dose of MHB039A