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Clinical Trials in China / NCT07130383
Recruiting Phase 2

A Study of MHB036C Combined With MHB039A in Patients With Advanced Breast Cancer or Other Advanced Malignant Solid Tumors

NCT07130383 · tracked via the Priya Life Science China tracker
Sponsor
Minghui Pharmaceutical (Hangzhou) Ltd
Phase
Phase 2
Started
2025-09-30
Last updated
2025-11-18

Condition(s) studied

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. \- 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)

Trial sites (1)

FacilityCityRegionStatus
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality Recruiting

More Minghui Pharmaceutical (Hangzhou) Ltd trials in China

Other trials for the same condition

Official registry record

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.

View NCT07130383 on ClinicalTrials.gov ↗ ← All trials in China