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NCT07130383RecruitingPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 9 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
210 (estimated)
First submitted
12 Aug 2025
Start date
30 Sept 2025
Primary completion date
Aug 2029
Lead sponsor
Minghui Pharmaceutical (Hangzhou) Ltd
NCT number
NCT07130383

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 210
  • From 30 Sept 2025 to the primary completion date, Aug 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • Vaccinated with attenuated live vaccines within 4 weeks before dosing.
  • Treated with with systemic corticosteroids within 14 days before dosing.
  • Known hypersensitivity or delayed allergic reaction to the investigational product or its components.
  • Known alcohol or drug dependence.

Other illness

  • Serious cardiovascular or cerebrovascular diseases.
  • Severe lung disease affecting pulmonary function.
  • Active infection requiring systemic therapy.
  • Drug abuse or other medical/psychiatric condition that may interfere with study participation or results.

Other

  • Central nervous system metastasis.
  • Uncontrolled third-space effusion.
  • Pregnant or breastfeeding women, or individuals planning to conceive.

Who the study is looking for

  • 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.
    • \-

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Fudan University Shanghai Cancer Center
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.