Combination of MHB088C and MHB039A for advanced solid tumors

An Open-label Phase I/II Clinical Study of MHB088C for Injection Combined With MHB039A for Injection in Patients With Advanced Malignant Solid Tumors

This will test whether combining two experimental drugs, MHB088C and MHB039A, is safe and can help adults with advanced solid tumors that haven't responded to standard treatments.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 116 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07126665 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18 years) with histologically or cytologically confirmed locally advanced or metastatic solid tumors, measurable disease by RECIST v1.1, ECOG 0–1, adequate organ function, and who are refractory to or lack standard treatment options are ideal candidates.

Not a fit: Patients with poor performance status (ECOG ≥2), inadequate organ function, or those who have effective standard treatment options available are unlikely to benefit or be eligible for this experimental combination.

Why it matters

Potential benefit: If successful, the combination could provide a new treatment option that controls tumor growth for patients with advanced solid tumors who have exhausted standard therapies.

How similar studies have performed: This specific combination is first-in-human and therefore untested in people, although other combination therapies for advanced solid tumors have shown benefit in certain settings.

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. 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 this trial is running

Shanghai, Shanghai Municipality

• Ethics Committee of Shanghai East Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: VP of R&D

Conditions Advanced Malignant Solid Tumor