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

NCT07130383 | Recruiting Phase 2

• 1 other identifier: MHB036C-E-202
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Breast Cancer; Advanced Malignant Solid Tumor

Outcome Measures

Primary Outcomes (1)

• (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).

  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

  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

  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

  Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years

• Overall survival (OS)

  Baseline up until death up to approximately 5 years

• Incidence and severity of adverse events (AEs)

  Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years.

Study Arms (7)

Safety run-in phase: cohort 1

EXPERIMENTAL

Subjects will receive MHB036C Q3W in combination with MHB039A Q3W by intravenous administration.

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.

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.

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.

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.

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.

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.

Drug: MHB036C for Injection; Drug: MHB039A for Injection

Interventions

MHB036C for Injection DRUG

Intravenous administration

Dose expansion phase: cohort 1; Dose expansion phase: cohort 2; Dose expansion phase: cohort 3; Dose expansion phase: cohort 4; Dose expansion phase: cohort 5; Safety run-in phase: cohort 1; Safety run-in phase: cohort 2

MHB039A for Injection DRUG

Intravenous administration

Dose expansion phase: cohort 1; Dose expansion phase: cohort 2; Dose expansion phase: cohort 3; Dose expansion phase: cohort 4; Dose expansion phase: cohort 5; Safety run-in phase: cohort 1; Safety run-in phase: cohort 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Minghui Pharmaceutical (Hangzhou) Ltd: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 201419, China

RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

VP of R&D

CONTACT

+86 0571-869632; jwshi@minghuipharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 19, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2031
• Last Updated: November 18, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)