An Open-label Phase II Clinical Study of MHB036C for Injection Combined With MHB039A for Injection in Patients With Advanced Breast Cancer or Other Advanced Malignant Solid Tumors
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is an open-label, multicenter Phase II study of MHB036C combined with MHB039A in patients with advanced Breast Cancer or other advanced malignant solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of MHB036C and MHB039A combination therapy.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• Voluntarily agrees to participate in the study and signs the informed consent form.
• Age ≥ 18 and ≤75 years, no restriction on gender.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Estimated life expectancy ≥ 3 months.
• Histologically or cytologically confirmed locally advanced or metastatic advanced solid tumors.
• At least one measurable lesion per RECIST v1.1 criteria.
• Adequate bone marrow reserve and organ function.
• Eligible participants of childbearing potential (males and females) must agree to take highly reliable contraceptive measures with their partners during the study and within at least 12 weeks after the last dose.
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Locations
Other Locations
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
VP of R&D
jwshi@minghuipharma.com
+86 0571-869632
Time Frame
Start Date:2025-09-30
Estimated Completion Date:2031-08
Participants
Target number of participants:210
Treatments
Experimental: Safety run-in phase: cohort 1
Subjects will receive MHB036C Q3W in combination with MHB039A Q3W by intravenous administration.
Experimental: Safety run-in phase: cohort 2
Subjects will receive MHB036C Q3W in combination with MHB039A Q3W by intravenous administration.
Experimental: Dose expansion phase: cohort 1
Subjects will receive MHB036C Q3W in combination with MHB039A Q3W by intravenous administration.
Experimental: Dose expansion phase: cohort 2
Subjects will receive MHB036C Q3W in combination with MHB039A Q3W by intravenous administration.
Experimental: Dose expansion phase: cohort 3
Subjects will receive MHB036C Q3W in combination with MHB039A Q3W by intravenous administration.
Experimental: Dose expansion phase: cohort 4
Subjects will receive MHB036C Q3W in combination with MHB039A Q3W by intravenous administration.
Experimental: Dose expansion phase: cohort 5
Subjects will receive MHB036C Q3W in combination with MHB039A Q3W by intravenous administration.