A Study of MHB039A for Advanced Solid Tumor

NCT06345482 | Active Not Recruiting Phase 1

• 1 other identifier: MHB039A-A-101
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Maximum Plasma Concentration (Cmax) of MHB039A

  Until 30 days after last dose of MHB039A

• The area under the plasma concentration-time curve (AUC) of MHB039A

  Until 30 days after last dose of MHB039A

• To detectable anti-drug antibodies with treated subjects

  Until 30 days after last dose of MHB039A

• Objective response rate (ORR)

  Until 30 days after last dose of MHB039A

Study Arms (1)

MHB039A

EXPERIMENTAL

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

Drug: MHB039A

Interventions

MHB039A DRUG

a bispecific antibody

MHB039A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Minghui Pharmaceutical (Hangzhou) Ltd: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Study Officials

• Shun Lu, MD

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: April 3, 2024
• Study Start: April 16, 2024
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)