Combination of MHB088C and MHB039A for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human, open-label Phase 1/2 trial that begins with a dose-escalation phase and moves to an indication expansion phase for specific tumor types. The dose-escalation stage will identify tolerable dose levels, characterize pharmacokinetics, and determine dose-limiting toxicities and a maximum tolerated dose. Patients must have measurable advanced solid tumors, ECOG performance status 0–1, and adequate organ function to enroll. The expansion phase will further examine safety and preliminary antitumor activity at dose levels that complete DLT evaluation.

Why it matters

Who can join: the full rules

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. For the dose escalation stage: Histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy, intolerant to standard therapy, or have no standard treatment options.
6. For the dose expansion stage: Histologically or cytologically confirmed locally advanced or metastatic advanced solid tumors, not suitable for radical surgery and/or radical concurrent/sequential radiotherapy and chemotherapy.
7. At least one measurable lesion per RECIST v1.1 criteria.
8. Adequate bone marrow reserve and organ function.
9. Eligible participants of childbearing potential (males and females) must agree to take highly reliable contraceptive measures with their partners during the study and within at least 12 weeks after the last dose.

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 dosing.
3. Medication of other unmarketed investigational drugs or therapies within 4 weeks before dosing.
4. Brain metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression.
5. Underwent major organ surgery (excluding biopsy) or significant trauma within 4 weeks before the first dose of investigational drug or requiring elective surgery during the study.
6. Previous or concurrent gastrointestinal perforation, surgical procedures and wound healing complications, as well as bleeding events.
7. Received intravenous thrombolysis treatment within 2 weeks, except for preventive anticoagulation and antiplatelet therapy.
8. Vaccinated within 4 weeks before dosing.
9. Treated with systemic corticosteroids within 14 days before dosing.
10. Severe lung disease affecting pulmonary function.
11. Active systemic infection requiring treatment within 7 days before dosing.
12. Uncontrolled third-space effusion.
13. Serious cardiovascular or cerebrovascular diseases.
14. Known hypersensitivity or delayed allergic reaction to the investigational product or its components.
15. Drug abuse or other medical/psychiatric condition that may interfere with study participation or results.
16. Known alcohol or drug dependence.
17. Pregnant or breastfeeding women, or individuals planning to conceive.

Where it's running

• Ethics Committee of Shanghai East Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: VP of R&D
• Email: jwshi@minghuipharma.com
• Phone: 86 0571-869632

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.