MHB036C combined with MHB039A for advanced breast cancer and other advanced 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

This trial will test whether the injectable combination of MHB036C and MHB039A is safe, well tolerated, and can shrink or control tumors in adults with advanced breast cancer or other advanced solid tumors.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 210 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd (Industry-sponsored)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07130383 on ClinicalTrials.gov

What this trial studies

This open-label, multicenter Phase II study begins with a safety run-in that includes dose escalation and an optional pharmacokinetics (PK) expansion, followed by an indication expansion phase. The safety run-in will identify tolerable dose levels and collect safety, tolerability, PK, and preliminary antitumor activity data. The sponsor will select dose levels from the run-in data to open multi-cohort expansion cohorts focused on advanced breast cancer and other specific solid tumor types. Eligible participants must have measurable disease by RECIST v1.1 and adequate organ function before receiving MHB036C and MHB039A injections.

Who should consider this trial

Good fit: Adults 18–75 with histologically confirmed advanced or metastatic solid tumors (including breast cancer), ECOG performance status 0–1, measurable disease, and adequate organ and marrow function who can meet contraception requirements are the ideal candidates.

Not a fit: Patients with poor performance status (ECOG ≥2), life expectancy under three months, recent anti-tumor therapy within the required washout period, uncontrolled medical conditions, or multiple recent primary malignancies are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the combination could offer a new treatment option that slows disease progression or reduces tumor size for patients with advanced breast cancer and other solid tumors.

How similar studies have performed: Combining two targeted or antibody agents has produced benefit in some cancers, but this specific MHB036C plus MHB039A combination is novel and has limited published human data.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: VP of R&D

Conditions Advanced Breast Cancer; Advanced Malignant Solid Tumor