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A Study of MHB046C Injection in Patients With Advanced Solid Tumors

ConditionAdvanced Solid Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMinghui Pharmaceutical (Hangzhou) Ltd

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily agrees to participate in the study and signs the informed consent form.

Age ≥ 18 years, no restriction on gender.

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Estimated life expectancy ≥ 3 months.

Disqualifiers

History of ≥2 primary malignancies within 5 years prior to informed consent.

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.

Brain metastases (unless asymptomatic, no edema, stable ≥4 weeks without steroids), leptomeningeal disease, brainstem metastases, or spinal cord compression.

Severe lung disease affecting pulmonary function.

Trial design

Design model

Sequential

Treatments tested in this trial

  • MHB046C

    Drug

    IV administration of MHB046C Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: MHB046C (Phase I: Dose escalation)Experimental treatment 1 intervention
Group B: MHB046C (Phase II: Dose expansion)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

I (Dose-Escalation Stage): Maximum tolerated dose (MTD) for MHB046C

To determine the MTD for further evaluation of IV administration of MHB046C in subjects with advanced solid tumors.

Time frame
Up to day 21 from the first dose
2

II (Dose-Expansion Stage): ORR determined by investigators according to RECIST v1.1

To determine the recommended Phase II dose (RP2D) of MHB046C for the treatment of selected patients with advanced solid tumors based on the safety and efficacy results from all enrolled subjects.

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

Secondary outcomes

1

Incidence and severity of adverse events (AEs)

AE assessed by investigator exclusively related to subject's underlying disease or medical condition \[graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0\].

Time frame
Baseline up to 5 years
2

Pharmacokinetic (PK) parameters of total antibody, ADC, and free toxin at various time points

The PK parameters at different time points include:Area Under the Concentration-Time Curve (AUC)

Time frame
From pre-dose to 22 days after the first dose
3

Pharmacokinetic (PK) parameters of total antibody, ADC, and free toxin at various time points

The PK parameters at different time points include:Maximum Plasma Concentration (Cmax)

Time frame
From pre-dose to 22 days after the first dose
4

Immunogenicity

Proportion of subjects who develop anti-MHB046C antibodies (ADA).

Time frame
From pre-dose to 30 days post end of treatment.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Minghui Pharmaceutical (Hangzhou) Ltd

Lead sponsor

Source ClinicalTrials.gov
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