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Trial Title:
A Study of MHB039A for Advanced Solid Tumor
NCT ID:
NCT06345482
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
MHB039A
Description:
a bispecific antibody
Arm group label:
MHB039A
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Chest Hospital
Address:
City:
Shanghai
Zip:
200030
Country:
China
Contact:
Last name:
Shun Lu, MD
Phone:
13601813062
Email:
shun_lu@hotmail.com
Start date:
April 1, 2024
Completion date:
June 1, 2029
Lead sponsor:
Agency:
Minghui Pharmaceutical (Hangzhou) Ltd
Agency class:
Industry
Source:
Minghui Pharmaceutical (Hangzhou) Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06345482
