Advanced Solid Tumor
Conditions
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.
Interventions
DRUGMHB039A
a bispecific antibody
Sponsors
Minghui Pharmaceutical (Hangzhou) Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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). |
| 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. |
Countries
China
Outcome results
None listed