A Study of MHB048C in Patients With Advanced Solid Tumors
Trial Parameters
Brief Summary
This is a first-in-human, open-label, multicenter Phase I/II study of MHB048C in patients with advanced solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB048C monotherapy.
Eligibility Criteria
Inclusion Criteria: 1. Voluntarily agrees to participate in the study and signs the informed consent form. 2. Age ≥ 18 years, no restriction on gender. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 4. Estimated life expectancy ≥ 3 months. 5. Histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy, intolerant to standard therapy, or have no standard treatment options. 6. At least one measurable lesion per RECIST v1.1 criteria or one bone. 7. Adequate bone marrow reserve and organ function. - Exclusion Criteria: 1. History of ≥2 primary malignancies within 5 years prior to informed consent. 2. Received chemotherapy within 3 weeks, radiotherapy within 4 weeks, or biologic, endocrine, or immunotherapy within 4 weeks before first study dose. 3. Medication of other unmarketed investigational drugs or therapies within 4 weeks before the first dose of investigational drug. 4. Brain metastases, bone marrow metastases, lep