A Study of MHB088C Combined With MHB039A in Patients With Advanced Malignant 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 MHB088C combined with MHB039A in patients with advanced malignant solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB088C and MHB039A combination therapy.

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 dosing.

Medication of other unmarketed investigational drugs or therapies within 4 weeks before dosing.

Brain metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression.

Trial design

Treatments tested in this trial

  • MHB088C for Injection
  • MHB039A for Injection

Treatment groups

116 Participants
are divided into 4 treatment groups