A Study of MHB048C in Patients With Advanced Solid Tumors
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 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 criteria
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, or biologic, endocrine, or immunotherapy within 4 weeks before first study dose.
Medication of other unmarketed investigational drugs or therapies within 4 weeks before the first dose of investigational drug.
Brain metastases, bone marrow metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression.
Trial design
Treatments tested in this trial
- MHB048C for Injection
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov