A Study of MHB088C Injection Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer
NCT ID: NCT06954246
Last Updated: 2025-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
450 participants
INTERVENTIONAL
2025-06-04
2028-04-30
Brief Summary
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Detailed Description
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The secondary objectives of the study are to further evaluate the efficacy/safety of MHB088C for Injection, immunogenicity of MHB088C, and characterize the pharmacokinetics of MHB088C.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MHB088C for Injection
Participants randomized to receive 2 mg/kg MHB088C monotherapy on Day 1 and Day 15 of each 28-day cycle until unacceptable toxicity, progressive disease (PD), or withdrawal of consent as specified in the protocol.
MHB088C for Injection
2 mg/kg intravenous dose on Day 1 and Day 15 of each 28-day cycle
Treatment of Physician's Chioce (TPC)
Participants randomized to receive topotecan, irinotecan, or paclitaxel, as per investigator's choice and per approved label (indicated dose and frequency), until a treatment discontinuation criterion is met as specified in the protocol.
Topotecan
1.25 mg/m\^2 intravenous dose on Day 1 to Day 5 of each 21-day cycle
Irinotecan
65 mg/m\^2 intravenous dose on Day 1 and Day 8 of each 21-day cycle
Paclitaxel
135 mg/m\^2 intravenous dose on Day 1 of each 21-day cycle
Interventions
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MHB088C for Injection
2 mg/kg intravenous dose on Day 1 and Day 15 of each 28-day cycle
Topotecan
1.25 mg/m\^2 intravenous dose on Day 1 to Day 5 of each 21-day cycle
Irinotecan
65 mg/m\^2 intravenous dose on Day 1 and Day 8 of each 21-day cycle
Paclitaxel
135 mg/m\^2 intravenous dose on Day 1 of each 21-day cycle
Eligibility Criteria
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Inclusion Criteria
1. Voluntarily consent to participate in this study and sign the informed consent form.
2. Adults ≥18 years, regardless of gender.
3. ECOG performance status score of 0-1.
4. Estimated survival time of more than 3 months.
5. Capable of understanding trial requirements, willing and able to comply with trial and follow-up procedures.
6. Has histologically or cytologically documented small cell lung cancer (SCLC).
7. 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. Prior PD-1/L1 systemic therapy was allowed to use with or without platinum-based regimens.
8. Agrees to provide pre-treatment tumor tissue samples for retrospective analysis of B7-H3 expression and other biomarkers.
9. Has at least 1 measurable lesion according to RECIST v1.1 as assessed by the investigator.
10. Sufficient bone marrow and organ function.
Exclusion Criteria
1. Diagnosis of other primary malignancies within 5 years prior to signing the informed consent form.
2. Prior pathological diagnosis of combined SCLC, or any transformed non-small cell lung cancer or transformed SCLC.
3. Receipt of chemotherapy within 4 weeks prior to the first administration of study drug, or receipt of radiotherapy, biologics, endocrine therapy, immunotherapy, or other anti-tumor therapy within 4 weeks prior to the first dose.
4. Previous or ongoing treatment with topoisomerase I inhibitors, including antibody-drug conjugates (ADCs) containing topoisomerase I inhibitor payloads.
5. Brain metastases (unless asymptomatic and stable for more than 4 weeks prior to randomization); presence of leptomeningeal metastases or brainstem metastases; spinal cord compression (identified via imaging, regardless of symptoms).
6. Bone marrow metastasis.
7. Prior B7-H3-targeted therapy.
8. Has uncontrolled or significant cardiovascular disease.
9. Moderate-to-severe pulmonary disease significantly impairing lung function, including idiopathic pulmonary fibrosis, autoimmune/connective tissue disorders with lung involvement, or prior pneumonectomy.
10. Has history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at Screening.
11. Moderate or severe pulmonary diseases severely affecting lung function.
12. Active tuberculosis, autoimmune diseases not in clinical remission, other acquired or congenital immunodeficiency diseases, or history of allogeneic stem cell, bone marrow, or organ transplantation.
13. Serious infections within 4 weeks before the first dose, including but not limited to those requiring systemic antibiotic therapy, bacteremia, or severe pneumonia.
14. Clinically uncontrolled third-space effusion requiring intervention, including pleural or peritoneal effusions.
15. Known hypersensitivity to investigational product components, analogues, or control drugs (e.g., topotecan, irinotecan, paclitaxel).
16. Pregnant or lactating women, or women/men intending to conceive.
18 Years
ALL
No
Sponsors
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Qilu Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Shanghai East Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MHB088C-P-301
Identifier Type: -
Identifier Source: org_study_id
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