A Study of MHB088C Injection Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer

NCT06954246 | Recruiting Phase 3

• 1 other identifier: MHB088C-P-301
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

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

Small Cell Lung Cancer Extensive Stage

Keywords

MHB088C; B7H3; Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  From the date of randomization to the date of death due to any cause, up to approximately 5 years

Secondary Outcomes (7)

• Number of Participants With Objective Response Rate Assessed by Investigator

  Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years

• Progression-free Survival As Assessed by Investigator

  Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years

• Duration of Response As Assessed by Investigator

  From the date of first documentation of confirmed response (CR or PR) to the first documentation of objective progression or to death due to any cause, whichever occurs first, up to approximately 5 years

• Disease Control Rate As Assessed by Investigator

  Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years

• Incidence and severity of adverse events (AEs), serious adverse events (SAEs), AEs leading to treatment interruption, and AEs leading to treatment discontinuation.

  Baseline up to 5 years

Study Arms (2)

MHB088C for Injection

EXPERIMENTAL

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.

Drug: MHB088C for Injection

Treatment of Physician's Chioce (TPC)

ACTIVE COMPARATOR

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.

Drug: Topotecan; Drug: Irinotecan; Drug: Paclitaxel

Interventions

MHB088C for Injection DRUG

2 mg/kg intravenous dose on Day 1 and Day 15 of each 28-day cycle

MHB088C for Injection

Topotecan DRUG

1.25 mg/m\^2 intravenous dose on Day 1 to Day 5 of each 21-day cycle

Treatment of Physician's Chioce (TPC)

Irinotecan DRUG

65 mg/m\^2 intravenous dose on Day 1 and Day 8 of each 21-day cycle

Treatment of Physician's Chioce (TPC)

Paclitaxel DRUG

135 mg/m\^2 intravenous dose on Day 1 of each 21-day cycle

Treatment of Physician's Chioce (TPC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet all the following criteria to be eligible for randomization into the study:
• Voluntarily consent to participate in this study and sign the informed consent form.
• Adults ≥18 years, regardless of gender.
• ECOG performance status score of 0-1.
• Estimated survival time of more than 3 months.
• Capable of understanding trial requirements, willing and able to comply with trial and follow-up procedures.
• Has histologically or cytologically documented 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. Prior PD-1/L1 systemic therapy was allowed to use with or without platinum-based regimens.
• Agrees to provide pre-treatment tumor tissue samples for retrospective analysis of B7-H3 expression and other biomarkers.
• Has at least 1 measurable lesion according to RECIST v1.1 as assessed by the investigator.
• Sufficient bone marrow and organ function.

You may not qualify if:

• Participants who meet any of the following criteria will be disqualified from entering the study:
• Diagnosis of other primary malignancies within 5 years prior to signing the informed consent form.
• Prior pathological diagnosis of combined SCLC, or any transformed non-small cell lung cancer or transformed SCLC.
• 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.
• Previous or ongoing treatment with topoisomerase I inhibitors, including antibody-drug conjugates (ADCs) containing topoisomerase I inhibitor payloads.
• 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).
• Bone marrow metastasis.
• Prior B7-H3-targeted therapy.
• Has uncontrolled or significant cardiovascular disease.
• Moderate-to-severe pulmonary disease significantly impairing lung function, including idiopathic pulmonary fibrosis, autoimmune/connective tissue disorders with lung involvement, or prior pneumonectomy.
• 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.
• Moderate or severe pulmonary diseases severely affecting lung function.
• 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.
• Serious infections within 4 weeks before the first dose, including but not limited to those requiring systemic antibiotic therapy, bacteremia, or severe pneumonia.
• Clinically uncontrolled third-space effusion requiring intervention, including pleural or peritoneal effusions.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shanghai East Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Injections; Topotecan; Irinotecan; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Camptothecin; Alkaloids; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Central Study Contacts

VP of R&D

CONTACT

86 0571-86963293; jwshi@minghuipharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: May 1, 2025
• Study Start: June 4, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: June 18, 2025

Record last verified: 2025-04

Locations

CN (1)