Clinical trial NCT06345482: A Study of MHB039A for Advanced Solid Tumor
Official title: A Phase I/II Study of MHB039A for Advanced Solid Tumor to Evaluate the Efficacy and Safety
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumor
Lead sponsor: Minghui Pharmaceutical (Hangzhou) Ltd
Sponsor class: INDUSTRY
First posted: 2024-04-03
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence of participants with adverse events (AE)
timeFrame: Until 30 days after last dose of MHB039A
measure: Number of participants with dose-limiting toxicity (DLT)
timeFrame: 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:
measure: Maximum Plasma Concentration (Cmax) of MHB039A
timeFrame: Until 30 days after last dose of MHB039A
measure: The area under the plasma concentration-time curve (AUC) of MHB039A
timeFrame: Until 30 days after last dose of MHB039A
measure: To detectable anti-drug antibodies with treated subjects
timeFrame: Until 30 days after last dose of MHB039A
measure: Objective response rate (ORR)
timeFrame: Until 30 days after last dose of MHB039A
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Chest Hospital
name: Shun Lu, MD
role: PRINCIPAL_INVESTIGATOR
References: