Advanced Breast CancerAdvanced Malignant Solid Tumor
Investigational drug(s) / intervention(s)
MHB036C for InjectionMHB039A for Injection
MHB036C for Injection: Intravenous administration
MHB039A for Injection: Intravenous administration
Study 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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Voluntarily agrees to participate in the study and signs the informed consent form.
2. Age ≥ 18 and ≤75 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 locally advanced or metastatic advanced solid tumors.
6. At least one measurable lesion per RECIST v1.1 criteria.
7. Adequate bone marrow reserve and organ function.
8. 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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Exclusion Criteria:
1. History of ≥2 primary malignancies within 5 years prior to informed consent.
2. Received anti-tumor treatment within 4 weeks or within the 5 half-lives of the previous treatment (whichever is shorter) before dosing.
3. Medication of other unmarketed investigational drugs or therapies within 4 weeks before dosing.
4. Undergone major organ surgery (excluding biopsy) or significant trauma within 4 weeks before dosing or requiring elective surgery during the study.
5. Vaccinated with attenuated live vaccines within 4 weeks before dosing.
6. Treated with with systemic corticosteroids within 14 days before dosing.
7. Central nervous system metastasis.
8. Uncontrolled third-space effusion.
9. Serious cardiovascular or cerebrovascular diseases.
10. Severe lung disease affecting pulmonary function.
11. Active infection requiring systemic therapy.
12. Known hypersensitivity or delayed allergic reaction to the investigational product or its components.
13. Drug abuse or other medical/psychiatric condition that may interfere with study participation or results.
14. Known alcohol or drug dependence.
15. Pregnant or breastfeeding women, or individuals planning to conceive.
Primary outcome measure(s)
(Dose-Expansion Stage): Objective tumor response (ORR) determined by investigators according to RECIST v1.1 — Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). ORR is evaluated by the number of participants with best overall response of CR and PR (Confirmed CR/PR assessment require at least 1 repeat).
Trial sites (1)
Facility
City
Region
Status
Fudan University Shanghai Cancer Center
Shanghai
Shanghai Municipality
Recruiting
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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