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NCT07192107 | RECRUITING | Advanced Malignant Solid Tumor

A Study of MHB042C in Patients With Advanced Solid Tumors
Sponsor:

Minghui Pharmaceutical (Hangzhou) Ltd

Brief Summary:

This is a first-in-human, open-label, multicenter Phase I/II study of MHB042C in patients with advanced solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB042C monotherapy.

Condition or disease

Advanced Malignant Solid Tumor

Intervention/treatment

MHB042C for Injection

Phase

PHASE1

PHASE2

Detailed Description:

This first-in-human clinical trial of MHB042C comprises two parts: a dose escalation phase and a dose expansion phase. The dose escalation phase is an open-label, multicenter study including dose escalation and PK expansion cohorts. The primary objectives are to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of MHB042C in patients with advanced solid tumors, and to determine the maximum tolerated dose (MTD). In this phase, additional patients may be enrolled in the PK expansion part at dose levels that have completed DLT (dose-limiting toxicity) evaluation. Based on the safety, PK, and preliminary efficacy data from the completed DLT-evaluated dose levels, the sponsor will initiate the dose expansion phase. This phase is an open-label, multicenter, multi-cohort study designed to further evaluate the safety and efficacy of MHB042C monotherapy in patients with specific types of advanced solid tumors.

Study Type : INTERVENTIONAL
Estimated Enrollment : 200 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MHB042C for Injection in Patients With Advanced Solid Tumors
Actual Study Start Date : 2025-10
Estimated Primary Completion Date : 2029-10
Estimated Study Completion Date : 2029-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Voluntarily agrees to participate in the study and signs the informed consent form.
  • 2. Age ≥ 18 years, no restriction on gender.
  • 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • 4. Estimated life expectancy ≥ 3 months.
  • 5. Histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy, intolerant to standard therapy, or have no standard treatment options.
  • 6. At least one measurable lesion per RECIST v1.1 criteria or one bone.
  • 7. Adequate bone marrow reserve and organ function. -
Exclusion Criteria
  • 1. History of ≥2 primary malignancies within 5 years prior to informed consent.
  • 2. Received chemotherapy within 3 weeks, radiotherapy within 4 weeks, or biologic, endocrine, or immunotherapy within 4 weeks before first study dose.
  • 3. Medication of other unmarketed investigational drugs or therapies within 4 weeks before the first dose of investigational drug.
  • 4. Brain metastases, bone marrow metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression.
  • 5. Severe bone damage caused by bone metastasis of prostate cancer.
  • 6. Has adverse reactions from previous anti-tumor treatment that have not recovered to ≤ CTCAE 5.0 Grade 1.
  • 7. Severe lung disease affecting pulmonary function.
  • 8. Vaccinated within 4 weeks before dosing.
  • 9. Active systemic infection requiring treatment within 7 days before dosing.
  • 10. Serious cardiovascular or cerebrovascular diseases.
  • 11. Uncontrolled third-space effusions not suitable for enrollment.
  • 12. Significant bleeding, bleeding tendency, or non-healing wounds within 1 month before first dose.
  • 13. Known hypersensitivity or delayed allergic reaction to the investigational product or its components.
  • 14. Drug abuse or other medical/psychiatric condition that may interfere with study participation or results.
  • 15. Known alcohol or drug dependence.
  • 16. Pregnant or breastfeeding women, or individuals planning to conceive. -
A Study of MHB042C in Patients With Advanced Solid Tumors

Location Details

NCT07192107

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

China, Guangdong

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China,