A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MHB048C for Injection in Patients With Advanced Solid Tumors

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

This is a first-in-human, open-label, multicenter Phase I/II study of MHB048C in patients with advanced solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB048C monotherapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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.

• Histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy, intolerant to standard therapy, or have no standard treatment options.

• At least one measurable lesion per RECIST v1.1 criteria or one bone.

• Adequate bone marrow reserve and organ function. -

Locations
Other Locations
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
CMO/ Senior Vice President of R&D
jwshi@minghuipharma.com
86 0571-86963293
Time Frame
Start Date: 2025-10
Estimated Completion Date: 2029-10
Participants
Target number of participants: 200
Treatments
Experimental: MHB048C (Phase I: Dose escalation)
There are seven escalating dose cohorts.
Experimental: MHB048C (Phase II: Dose expansion)
The recommended dose from the dose-escalation stage and other potential doses will be further explored.
Related Therapeutic Areas
Sponsors
Leads: Minghui Pharmaceutical (Hangzhou) Ltd

This content was sourced from clinicaltrials.gov