Clinical trial NCT06985355: A Study of MHB046C Injection in Patients With Advanced Solid Tumors
Official title: A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MHB046C Injection in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Cancer
Lead sponsor: Minghui Pharmaceutical (Hangzhou) Ltd
Sponsor class: INDUSTRY
First posted: 2025-05-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a first-in-human, open-label, multicenter Phase I/II study of MHB046C in patients with advanced solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB046C monotherapy.

Detailed description: This first-in-human clinical trial of MHB046C comprises two parts: a dose escalation phase and an indication expansion phase. The dose escalation phase is an open-label, multicenter study including dose escalation and PK expansion cohorts. The primary objectives are to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of MHB046C in patients with advanced solid tumors, and to determine the maximum tolerated dose (MTD). In this phase, additional patients may be enrolled in the PK expansion part at dose levels that have completed DLT (dose-limiting toxicity) evaluation.

Based on the safety, PK, and preliminary efficacy data from the completed DLT-evaluated dose levels, the sponsor will initiate the indication expansion phase. This phase is an open-label, multicenter, multi-cohort study designed to further evaluate the safety and efficacy of MHB046C monotherapy in patients with specific types of advanced solid tumors.

Eligibility criteria: Inclusion Criteria:

1. Voluntarily agrees to participate in the study and signs the informed consent form.
2. Age ≥ 18 years, no restriction on gender.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. Estimated life expectancy ≥ 3 months.
5. Able to understand and comply with the study protocol and follow-up procedures.
6. Histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy, intolerant to standard therapy, or have no standard treatment options.
7. At least one measurable lesion per RECIST v1.1 criteria.
8. Adequate organ function.

Exclusion Criteria:

1. History of ≥2 primary malignancies within 5 years prior to informed consent.
2. Received chemotherapy within 3 weeks, radiotherapy within 4 weeks (2 weeks for palliative bone radiotherapy), or biologic, endocrine, or immunotherapy within 4 weeks before first study dose.
3. Brain metastases (unless asymptomatic, no edema, stable ≥4 weeks without steroids), leptomeningeal disease, brainstem metastases, or spinal cord compression.
4. Severe lung disease affecting pulmonary function.
5. Active systemic infection requiring treatment within 7 days before dosing.
6. Serious cardiovascular or cerebrovascular diseases
7. Uncontrolled third-space effusions not suitable for enrollment:
8. Uncontrolled diabetes, including ketoacidosis or hyperosmolar state within 6 months.
9. Significant bleeding, bleeding tendency, or non-healing wounds within 1 month before first dose.
10. Known hypersensitivity or delayed allergic reaction to the investigational product or its components.
11. Drug abuse or other medical/psychiatric condition that may interfere with study participation or results.
12. Known alcohol or drug dependence.
13. Pregnant or breastfeeding women, or individuals planning to conceive.

Primary outcomes:
measure: I (Dose-Escalation Stage): Maximum tolerated dose (MTD) for MHB046C
timeFrame: Up to day 21 from the first dose
measure: II (Dose-Expansion Stage): ORR determined by investigators according to RECIST v1.1
timeFrame: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years
Secondary outcomes:
measure: Incidence and severity of adverse events (AEs)
timeFrame: Baseline up to 5 years
measure: Pharmacokinetic (PK) parameters of total antibody, ADC, and free toxin at various time points
timeFrame: From pre-dose to 22 days after the first dose
measure: Pharmacokinetic (PK) parameters of total antibody, ADC, and free toxin at various time points
timeFrame: From pre-dose to 22 days after the first dose
measure: Immunogenicity
timeFrame: From pre-dose to 30 days post end of treatment.
measure: ORR determined by investigators according to RECIST v1.1
timeFrame: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years
measure: Duration of response (DOR) determined by investigators according to RECIST v1.1
timeFrame: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years
measure: Disease control rate (DCR) determined by investigators according to RECIST v1.1
timeFrame: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years
measure: Progression-free survival (PFS) determined by investigators according to RECIST v1.1
timeFrame: Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years
measure: Overall survival (OS)
timeFrame: Baseline up until death up to approximately 5 years
Other outcomes:
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