Advanced Breast CancerPhase 2NCT07130383
A Study of MHB036C Combined With MHB039A in Patients With Advanced Breast Cancer or Other Advanced Malignant Solid Tumors
A Phase 2 study testing MHB036C for Injection and MHB039A for Injection in people with Advanced Breast Cancer and Advanced Malignant Solid Tumor, run by Minghui Pharmaceutical (Hangzhou) Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Breast Cancer, Advanced Malignant Solid Tumor
- What is being tested?
- MHB036C for Injection and MHB039A for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2025to Aug 2031
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- -
Who cannot join
- 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.
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- Central nervous system metastasis.
- Uncontrolled third-space effusion.
- Serious cardiovascular or cerebrovascular diseases.
- Severe lung disease affecting pulmonary function.
- Active infection requiring systemic therapy.
- Known hypersensitivity or delayed allergic reaction to the investigational product or its components.
- Drug abuse or other medical/psychiatric condition that may interfere with study participation or results.
- Known alcohol or drug dependence.
- Pregnant or breastfeeding women, or individuals planning to conceive.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 201419
Ethics Committee, +86 021-64175590-85033, JJYIN555@163.com
About this study
Official title: 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
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.
Read the detailed description
This phase II clinical trial of MHB036C and MHB039A combination therapy comprises two parts: a safety run-in phase and an indication expansion phase. The safety run-in phase includes a dose escalation part and an optional PK expansion part. The primary objectives are to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of MHB036C combined with MHB039A in patients with advanced solid tumors. The optional PK expansion part is allowed to enroll additional patients at any non-DLT dose levels that have completed DLT (dose-limiting toxicity) evaluation.
Based on the safety, PK, and preliminary efficacy data from the safety run-in phase, the sponsor will initiate the indication expansion phase at selected dose levels. This phase is an open-label, multicenter, multi-cohort study designed to further evaluate the efficacy and safety of MHB036C and MHB039A combination therapy in patients with advanced breast cancer and other specific types of advanced solid tumors.
- Being tested
- MHB036C for Injection, MHB039A for Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MHB036C for InjectionDrug
Intravenous administration
MHB039A for InjectionDrug
Intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| Safety run-in phase: cohort 1 | Experimental | Subjects will receive MHB036C Q3W in combination with MHB039A Q3W by intravenous administration. Receives: Drug: MHB036C for Injection; Drug: MHB039A for Injection |
| Safety run-in phase: cohort 2 | Experimental | Subjects will receive MHB036C Q3W in combination with MHB039A Q3W by intravenous administration. Receives: Drug: MHB036C for Injection; Drug: MHB039A for Injection |
| Dose expansion phase: cohort 1 | Experimental | Subjects will receive MHB036C Q3W in combination with MHB039A Q3W by intravenous administration. Receives: Drug: MHB036C for Injection; Drug: MHB039A for Injection |
| Dose expansion phase: cohort 2 | Experimental | Subjects will receive MHB036C Q3W in combination with MHB039A Q3W by intravenous administration. Receives: Drug: MHB036C for Injection; Drug: MHB039A for Injection |
| Dose expansion phase: cohort 3 | Experimental | Subjects will receive MHB036C Q3W in combination with MHB039A Q3W by intravenous administration. Receives: Drug: MHB036C for Injection; Drug: MHB039A for Injection |
| Dose expansion phase: cohort 4 | Experimental | Subjects will receive MHB036C Q3W in combination with MHB039A Q3W by intravenous administration. Receives: Drug: MHB036C for Injection; Drug: MHB039A for Injection |
| Dose expansion phase: cohort 5 | Experimental | Subjects will receive MHB036C Q3W in combination with MHB039A Q3W by intravenous administration. Receives: Drug: MHB036C for Injection; Drug: MHB039A for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
(Dose-Expansion Stage): Objective tumor response (ORR) determined by investigators according to RECIST v1.1
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).
Measured: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years
Secondary outcomes (7)
Duration of response (DOR) determined by investigators according to RECIST v1.1
DoR was defined as the period from the first occurrence of CR or PR to PD or death from any cause. If no PD or death after CR/PR, the cut-off date of progression-free survival (PFS) would be used [Confirmed CR/PR assessment require at least one repeat (≥4 weeks)].
Measured: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years
Disease control rate (DCR) determined by investigators according to RECIST v1.1
Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). DCR was evaluated by the number of participants with best overall response of CR, PR and stable disease (SD) [Confirmed CR/PR assessment require at least one repeat (≥4 weeks); SD shall be assessed at least 5 weeks after the first dose].
Measured: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years
Progression-free survival (PFS) determined by investigators according to RECIST v1.1
Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). PFS was defined as the time from random assignment (dose expansion stage) or first dose (dose escalation stage) to PD or death from any cause.
Measured: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years
Overall survival (OS)
OS was defined as the time from random assignment or first dose to death from any cause.
Measured: Baseline up until death up to approximately 5 years
Incidence and severity of adverse events (AEs)
AE assessed by investigator exclusively related to subject's underlying disease or medical condition [graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0].
Measured: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years.
Pharmacokinetic (PK) parameters of total antibody, ADC, and free toxin at various time points
The PK parameters at different time points include:Area Under the Concentration-Time Curve (AUC).
Measured: From pre-dose to 22 days after the first dose
Pharmacokinetic (PK) parameters of total antibody, ADC, and free toxin at various time points
The PK parameters at different time points include:Maximum Plasma Concentration (Cmax).
Measured: From pre-dose to 22 days after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start30 Sep 2025
- Primary completionAug 2029 (estimated)
- Study completionAug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minghui Pharmaceutical (Hangzhou) Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07130383
- Sponsor's protocol ID
- MHB036C-E-202
- Status last verified
- Oct 2026
- First submitted
- 12 Aug 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No