Phase I/II open label, multicenter study to evaluate the efficacy and safety of MHB039A in advanced malignant tumors.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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
Primary outcome measure(s)
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.
Trial sites (1)
Facility
City
Region
Status
Shanghai Chest Hospital
Shanghai
Shanghai Municipality
More Minghui Pharmaceutical (Hangzhou) Ltd trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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