About this trial
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 criteria
Qualifiers
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.
Disqualifiers
History of ≥2 primary malignancies within 5 years prior to informed consent.
Received anti-tumor treatment within 4 weeks or within the 5 half-lives of the previous treatment (whichever is shorter) before dosing.
Medication of other unmarketed investigational drugs or therapies within 4 weeks before dosing.
Undergone major organ surgery (excluding biopsy) or significant trauma within 4 weeks before dosing or requiring elective surgery during the study.
Trial design
Treatments tested in this trial
- MHB036C for Injection
- MHB039A for Injection
Treatment groups
7
Treatment groupsSee each treatment group below.