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A Study of MHB118C Injection in Patients With Advanced Solid Tumors

ConditionAdvanced Malignant Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMinghui Pharmaceutical (Hangzhou) Ltd

About this trial

This is a first-in-human, open-label, multicenter Phase I study of MHB118C in patients with advanced solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB118C 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, leptomeningeal disease, brainstem metastases, or spinal cord compression.

Severe lung disease affecting pulmonary function.

Trial design

Design model

Single group

Treatments tested in this trial

  • MHB118C for Injection

    Drug

    IV administration by 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 1 treatment group
Group A: MHB118C for InjectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose-Limiting Toxicity (DLT) for MHB118C

DLTs will be assessed during the dose-escalation phase and are defined as toxicities related to MHB118C

Time frame
Up to day 21 from the first dose
2

Maximum tolerated dose (MTD) for MHB118C

To determine the MTD for further evaluation of IV administration of MHB118C in subjects with advanced solid tumors.

Time frame
Up to day 21 from the first dose

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
Baseline up to 5 years
3

Immunogenicity

Proportion of subjects who develop anti-MHB118C antibodies (ADA).

Time frame
Baseline up to 5 years
4

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. ORR is evaluated by the number of participants with best overall response of CR and PR .

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

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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