NCT06985355 A Study of MHB046C Injection in Patients With Advanced Solid Tumors
| NCT ID | NCT06985355 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Minghui Pharmaceutical (Hangzhou) Ltd |
| Condition | Advanced Solid Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-07-17 |
| Primary Completion | 2029-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 200 participants in total. It began in 2025-07-17 with a primary completion date of 2029-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a first-in-human, open-label, multicenter Phase I/II study of MHB046C in patients with advanced solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB046C monotherapy.
Eligibility 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. Able to understand and comply with the study protocol and follow-up procedures. 6. Histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy, intolerant to standard therapy, or have no standard treatment options. 7. At least one measurable lesion per RECIST v1.1 criteria. 8. Adequate 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 (2 weeks for palliative bone radiotherapy), or biologic, endocrine, or immunotherapy within 4 weeks before first study dose. 3. Brain metastases (unless asymptomatic, no edema, stable ≥4 weeks without steroids), leptomeningeal disease, brainstem metastases, or spinal cord compression. 4. Severe lung disease affecting pulmonary function. 5. Active systemic infection requiring treatment within 7 days before dosing. 6. Serious cardiovascular or cerebrovascular diseases 7. Uncontrolled third-space effusions not suitable for enrollment: 8. Uncontrolled diabetes, including ketoacidosis or hyperosmolar state within 6 months. 9. Significant bleeding, bleeding tendency, or non-healing wounds within 1 month before first dose. 10. Known hypersensitivity or delayed allergic reaction to the investigational product or its components. 11. Drug abuse or other medical/psychiatric condition that may interfere with study participation or results. 12. Known alcohol or drug dependence. 13. Pregnant or breastfeeding women, or individuals planning to conceive.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06985355 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Solid Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06985355 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06985355 currently recruiting?
Yes, NCT06985355 is actively recruiting participants. Contact the research team at jwshi@minghuipharma.com for enrollment information.
Where is the NCT06985355 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06985355 clinical trial?
NCT06985355 is sponsored by Minghui Pharmaceutical (Hangzhou) Ltd. The trial plans to enroll 200 participants.
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