MHB036C given with other cancer medicines for advanced lung cancer

A Phase I/II Clinical Study to Evaluate the Efficacy and Safety of MHB036C for Injection Combined With Other Anti-tumor Therapy in Patients With Advanced Lung Cancer

This study will try MHB036C together with other cancer medicines in adults with advanced lung cancer to see if the combination is safe and helps control tumors.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, Furmonertinib
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07229599 on ClinicalTrials.gov

What this trial studies

This is a first-in-human, open-label Phase 1/2 program testing MHB036C in combination with MHB039A, Furmonertinib, Carboplatin, or other anti-tumor therapies in patients with advanced lung cancer. The trial has a dose-escalation stage with DLT and PK expansion cohorts to identify the maximum tolerated dose and characterize pharmacokinetics and safety. Based on safety, PK, and preliminary antitumor signals from completed dose levels, a dose-expansion stage will enroll patients with specific types of advanced lung cancer to further evaluate safety and preliminary efficacy. The study requires measurable disease by RECIST v1.1 and adequate organ function, and is open-label with multiple combination regimens.

Who should consider this trial

Good fit: Adults aged 18–75 with histologically confirmed locally advanced or metastatic lung cancer, ECOG 0–1, at least one measurable lesion, and adequate organ function are the intended participants.

Not a fit: Patients with poor performance status (ECOG >1), very limited life expectancy, inadequate organ function, or those eligible for curative-intent therapy are unlikely to benefit from this early-phase combination study.

Why it matters

Potential benefit: If successful, the combination could offer a new treatment option that is better tolerated or more effective for some people with advanced lung cancer who have limited options.

How similar studies have performed: This is the first-in-human trial for MHB036C, so the agent itself is untested in people, although combining antibody or targeted agents with chemotherapy or EGFR inhibitors has shown benefit in other lung cancer settings.

Eligibility criteria

Inclusion Criteria:

1. Voluntarily agrees to participate in the study and signs the informed consent form.
2. Age ≥ 18 years and≤75 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.

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Exclusion Criteria:

1. Small cell lung cancer (SCLC) components in the histopathology.
2. History of ≥2 primary malignancies within 5 years prior to informed consent.
3. Received chemotherapy within 3 weeks, radiotherapy within 4 weeks, or biologic, endocrine, or immunotherapy within 4 weeks before first study dose.
4. Medication of other unmarketed investigational drugs or therapies within 4 weeks before dosing.
5. Brain metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression.
6. 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.
7. Previous or concurrent gastrointestinal perforation, surgical procedures and wound healing complications, as well as bleeding events.
8. Received intravenous thrombolysis treatment within 2 weeks, except for preventive anticoagulation and antiplatelet therapy.
9. Vaccinated within 4 weeks before dosing.
10. Treated with systemic corticosteroids within 14 days before dosing.
11. Severe impairment of pulmonary function; interstitial lung disease or a history of pneumonia requiring steroid treatment; previous left or right pneumonectomy.
12. Active systemic infection requiring treatment within 7 days before dosing.
13. Uncontrolled third-space effusion.
14. Serious cardiovascular or cerebrovascular diseases.
15. Known hypersensitivity or delayed allergic reaction to the investigational product or its components.
16. Drug abuse or other medical/psychiatric condition that may interfere with study participation or results.
17. Known alcohol or drug dependence.
18. Pregnant or breastfeeding women, or individuals planning to conceive. -

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: CMO/ Senior Vice President of R&D

Conditions Advanced Lung Cancer