Actively Recruiting
A Phase 3, Multicenter, Randomized, Open-label Study of MHB088C for 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
48 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of MHB088C for Injection compared with the treatment of physician's choice in adults with relapsed small cell lung cancer (SCLC). This Phase 3, randomized, open-label study aims primarily to see if MHB088C can extend overall survival. Secondary goals include assessing the drug's safety, immune response, and how the body processes it. Participants are randomly assigned to one of two groups. One group receives MHB088C at a dose of 2 mg/kg intravenously on Day 1 and Day 15 of a 28-day cycle, continuing until unacceptable side effects, disease progression, or withdrawal. The other group receives one of three chemotherapy drugs chosen by their doctor—topotecan, irinotecan, or paclitaxel—given according to approved dosing schedules until treatment discontinuation criteria are met. During the study, participants will undergo regular assessments including monitoring survival from randomization up to approximately five years, tumor response evaluations, progression tracking, and safety checks for adverse events. Blood samples will be collected to study drug levels and immune markers. These evaluations help researchers understand both the benefits and risks of MHB088C compared to standard treatments. The total participation may last up to five years from enrollment, covering treatment and follow-up phases.
CONDITIONS
Brief 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.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Estimated survival time longer than 3 months.
- Able to understand and comply with trial and follow-up procedures.
- Histologically or cytologically confirmed small cell lung cancer.
- Extensive-stage SCLC with progression after at least two cycles of platinum-based and PD-1/L1 systemic therapy, with no more than two prior therapy lines.
- Willing to provide pre-treatment tumor tissue for biomarker analysis.
- At least one measurable lesion as per RECIST v1.1.
- Adequate bone marrow and organ function.
You will not qualify if you...
- Diagnosis of other primary cancers within 5 years prior to consent.
- Prior diagnosis of combined SCLC or transformed lung cancers.
- Chemotherapy within 4 weeks before first study drug dose, or radiotherapy, biologics, endocrine therapy, immunotherapy, or other anti-tumor therapy within 4 weeks prior.
- Previous or ongoing treatment with topoisomerase I inhibitors or related antibody-drug conjugates.
- Brain metastases unless asymptomatic and stable for more than 4 weeks; leptomeningeal or brainstem metastases; spinal cord compression.
- Bone marrow metastasis.
- Prior therapy targeting B7-H3.
- Uncontrolled or significant cardiovascular disease.
- Moderate-to-severe pulmonary disease severely impairing lung function.
- History or presence of interstitial lung disease or pneumonitis requiring corticosteroids or suspected by imaging.
- Active tuberculosis, autoimmune diseases not in remission, immunodeficiency diseases, or history of stem cell/organ transplant.
- Serious infections within 4 weeks before first dose.
- Uncontrolled third-space effusions requiring intervention.
- Known hypersensitivity to study drugs or components.
- Pregnant or lactating women or those intending to conceive.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day or 21-day cycles until unacceptable toxicity, progressive disease, or withdrawal
Participants receive either MHB088C for Injection or one of the physician's choice treatments (topotecan, irinotecan, or paclitaxel) intravenously in cycles until unacceptable toxicity, disease progression, or withdrawal.
Treatment visits according to cycle schedule (Day 1 and Day 15 for MHB088C; Day 1 to Day 5 or Day 1 and 8 or Day 1 for comparator drugs)
Trial Site Locations
Total: 1 location
1
Shanghai East Hospital
Shanghai, China
Actively Recruiting
Research Team
V
VP of R&D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here