A Study of MHB036C Combined With MHB039A in Patients With Advanced Breast Cancer or Other Advanced Malignant Solid Tumors
NCT ID: NCT07130383
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
210 participants
INTERVENTIONAL
2025-09-30
2031-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Safety run-in phase: cohort 1
Subjects will receive MHB036C Q3W in combination with MHB039A Q3W by intravenous administration.
MHB036C for Injection
Intravenous administration
MHB039A for Injection
Intravenous administration
Safety run-in phase: cohort 2
Subjects will receive MHB036C Q3W in combination with MHB039A Q3W by intravenous administration.
MHB036C for Injection
Intravenous administration
MHB039A for Injection
Intravenous administration
Dose expansion phase: cohort 1
Subjects will receive MHB036C Q3W in combination with MHB039A Q3W by intravenous administration.
MHB036C for Injection
Intravenous administration
MHB039A for Injection
Intravenous administration
Dose expansion phase: cohort 2
Subjects will receive MHB036C Q3W in combination with MHB039A Q3W by intravenous administration.
MHB036C for Injection
Intravenous administration
MHB039A for Injection
Intravenous administration
Dose expansion phase: cohort 3
Subjects will receive MHB036C Q3W in combination with MHB039A Q3W by intravenous administration.
MHB036C for Injection
Intravenous administration
MHB039A for Injection
Intravenous administration
Dose expansion phase: cohort 4
Subjects will receive MHB036C Q3W in combination with MHB039A Q3W by intravenous administration.
MHB036C for Injection
Intravenous administration
MHB039A for Injection
Intravenous administration
Dose expansion phase: cohort 5
Subjects will receive MHB036C Q3W in combination with MHB039A Q3W by intravenous administration.
MHB036C for Injection
Intravenous administration
MHB039A for Injection
Intravenous administration
Interventions
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MHB036C for Injection
Intravenous administration
MHB039A for Injection
Intravenous administration
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Minghui Pharmaceutical (Hangzhou) Ltd
INDUSTRY
Responsible Party
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Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MHB036C-E-202
Identifier Type: -
Identifier Source: org_study_id
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