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

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

Overview

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.

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.

Interventions

• Drug MHB036C for Injection
  Intravenous administration
• Drug MHB039A for Injection
  Intravenous administration

Primary outcome measures

• (Dose-Expansion Stage): Objective tumor response (ORR) determined by investigators according to RECIST v1.1 [Time frame: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years]

Secondary outcome measures (7)

• Duration of response (DOR) determined by investigators according to RECIST v1.1 [Time frame: 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 [Time frame: 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 [Time frame: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years]
• Overall survival (OS) [Time frame: Baseline up until death up to approximately 5 years]
• Incidence and severity of adverse events (AEs) [Time frame: 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 [Time frame: From pre-dose to 22 days after the first dose]
• Pharmacokinetic (PK) parameters of total antibody, ADC, and free toxin at various time points [Time frame: From pre-dose to 22 days after the first dose]

Eligibility criteria

Inclusion criteria

• 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.

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Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Fudan University Shanghai Cancer Center — Shanghai

Identifiers

NCT: NCT07130383 · MHB036C-E-202

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗