Actively Recruiting
A Study of MHB088C Injection Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer
Led by Qilu Pharmaceutical Co., Ltd. · Updated on 2025-06-18
450
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study was designed to compare the efficacy and safety of MHB088C for Injection with treatment of physician's choice (TPC) in participants with relapsed small cell lung cancer (SCLC).
CONDITIONS
Official Title
A Study of MHB088C Injection Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must voluntarily consent and sign the informed consent form.
- Adults aged 18 years or older, any gender.
- ECOG performance status score of 0 or 1.
- Estimated survival time longer than 3 months.
- Able to understand trial requirements and willing to follow study and follow-up procedures.
- Diagnosed with histologically or cytologically confirmed small cell lung cancer (SCLC).
- Extensive-stage SCLC with disease progression after at least two cycles of platinum-based and PD-1/L1 systemic therapy, with no more than two prior lines of therapy.
- Willing to provide pre-treatment tumor tissue samples for biomarker analysis.
- At least one measurable lesion according to RECIST v1.1.
- Adequate bone marrow and organ function.
You will not qualify if you...
- Diagnosis of other primary cancers within 5 years before consenting.
- Prior diagnosis of combined SCLC or transformed non-small cell lung cancer.
- Received chemotherapy, radiotherapy, biologics, endocrine therapy, immunotherapy, or other anti-tumor treatments within 4 weeks before first study drug dose.
- Previous or ongoing treatment with topoisomerase I inhibitors, including ADCs with topoisomerase I payloads.
- Brain metastases unless asymptomatic and stable for over 4 weeks; leptomeningeal or brainstem metastases; spinal cord compression.
- Bone marrow metastasis.
- Prior treatment targeting B7-H3.
- Uncontrolled or significant cardiovascular disease.
- Moderate-to-severe lung diseases impairing lung function, including idiopathic pulmonary fibrosis, autoimmune/connective tissue disorders with lung involvement, or prior pneumonectomy.
- History or current interstitial lung disease (ILD)/pneumonitis requiring corticosteroids or suspected ILD/pneumonitis not ruled out by imaging.
- Active tuberculosis, autoimmune diseases not in remission, immunodeficiency diseases, or history of stem cell, bone marrow, or organ transplant.
- Serious infections within 4 weeks before first dose.
- Clinically uncontrolled fluid buildup requiring intervention.
- Known allergy to study drugs or related compounds.
- Pregnant or breastfeeding women, or those intending to conceive.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shanghai East Hospital
Shanghai, China
Actively Recruiting
Research Team
V
VP of R&D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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