Small Cell Lung Cancer
Conditions
Interventions
MHB088C Group:MHB088C for injection
The chemotherapy group selected by the investigators:lrinotecan Hydrochloride Injection
The chemotherapy group selected by the investigators:Paclitaxel Injection
The chemotherapy group selected by the investigators:Topotecan Hydrochloride for Injection
Sponsors
Shanghai East Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Subjects voluntarily agree to participate in this study and sign informed consent. 2.Age >=18 years old, gender unlimited. 3.ECOG Physical strength score 0-1. 4.The expected survival time is more than 3 months. 5.Eligible subjects (male and female) who are fertile must agree to use a reliable contraceptive method (hormonal or barrier method or abstinence, etc.) with their partner during the trial period and for at least 90 days after the last dose; Female subjects of reproductive age must have a negative blood pregnancy test within 7 days prior to first use of the study drug and must be non-lactating. Agree not to retrieve, freeze, or donate sperm or eggs from the screening period, throughout the study period, and for at least 3 months after the final study drug is used. 6.Able to understand the test requirements, willing and able to follow the test and follow-up procedures. 7.Histologically or cytologically confirmed small cell lung cancer requires pathological and immunohistochemical/cell phenotypic results for diagnosis. 8.Extensive small-cell lung cancer that progresses after at least two cycles of platinum-containing, PD-1/L1 systemic therapy(at enrollment), and the number of previous treatment lines does not exceed 2 lines, PD-1/L1 systemic treatment can be included Platinum scheme combined or not combined. Note: 1, previous treatment lines: disease progression occurred during adjuvant therapy or within 6 months after the end of the last adjuvant therapy, adjuvant therapy is considered as 1 Line count therapy; 2. Staging of SCLC is based on the American Veterans Lung Cancer Association (VALG) Phase II staging (see Appendix 7). 9.Agree to provide pre-treatment tumor tissue samples for retrospective analysis of B7-H3 expression and other biomarkers in at least 5 unstained FFPE tumor tissue sections. 10.Have at least one measurable tumor lesion according to RECIST v1.1 tumor evaluation criteria; If a tumor lesion that has been locally treated before is used as a target lesion, it needs to show clear progress after local treatment. Only brain lesions are not accepted as target lesions. 11.Adequate bone marrow functional reserve: (no blood transfusion, colony-stimulating factor, or biologics with similar effects received within 7 days prior to screening) ?1? Absolute neutrophil count (ANC) >=1.5×10^9/L; 2?Platelet count >=100×10^9/L; 3? Hemoglobin >=90g/L. 12.Adequate liver function: (based on the normal value of the clinical trial center) ?1?Total bilirubin (TBIL) =50mL/min (using the Cockcroft-Gault formula or other
Exclusion criteria
Exclusion criteria: 1.Patients with other primary malignant tumors within 5 years before signing the informed consent, except for the following cases: 1?Malignant tumors that have been cured and have no recurrence in the 5 years before being enrolled in the study; 2?Non-melanoma skin cancer, cervical carcinoma in situ, thyroid cancer, or other malignancies considered cured after adequate treatment and without evidence of disease recurrence. 2.A previous pathological diagnosis of complex small cell lung cancer (e.g., mixed SCLC and NSCLC) or any transformed non-small cell lung cancer (SCLC to NSCLC) or transformed SCLC (NSCLC to SCLC). 3.Therapy, biomacromolecular therapy, endocrine therapy, immunotherapy and other anti-tumor therapy, and the following conditions: 1? the local application of anti-tumor drugs is within 5 half-lives before the first use of investigational drugs; 2?Nitrosourea or mitomycin C within 6 weeks before the first use of the investigatory drug; 3?Oral fluorouracil and small molecule targeted drugs should be taken within 5 half-lives before the first use of the investigatory drugs; 4?Chinese medicines with anti-tumor indications should be used within 2 weeks before the first use of the investigational drugs. 4.Received another investigational drug or treatment that is not on the market in the 4 weeks prior to initial use of the investigational drug. 5.Topoisomerase I inhibitor drugs have been used or are being used in the past, including antibo-coupled drugs with topoisomerase I inhibitor payloads, such as topotecan, irinotecan, dextrastuzumab, Goxstuzumab, Dato-Dxd (DS-1062), etc. 6.Brain metastases (unless asymptomatic, i.e., stable for more than 4 weeks prior to randomization, no prednisone or equivalent dose of the same drug is required for at least 14 days prior to initial administration, and there is no significant edema around the tumor lesion on imaging findings); Meningeal metastasis or brain stem metastasis is present; Spinal cord compression is present (as detected by radiographic examination, whether symptomatic or not). 7.Bone marrow metastasis. 8.Previously received B7-H3 targeted therapy, such as MGC018, DS-7300a, ABBV-155, BAT8009, Enoblituzumab, Omburtamab, etc. 9.Toxicity>=2 according to the Common terminology criteria for Adverse Events (CTCAE version 5.0) (except for alopecia, residual neurotoxicity, and stable hypothyroidism after hormone replacement therapy). 10.Had major organ surgery (excluding biopsy and vascular access establishment) or significant trauma within 4 weeks prior to the first use of the study drug, or required elective surgery during the trial period. 11.Use of live or attenuated vaccine within 4 weeks prior to the first administration of the investigational drug. 12.Received systemic use of glucocorticoids (prednisone >10mg/ day or equivalent dose of the same drug) or other immunosuppressants within 14 days prior to the first use of the study drug, except for the following: 1?Use local, ocular, intra-articular, intranasal and inhaled glucocorticoids; 2?short-term use of glucocorticoids for preventive treatment (such as prevention of contrast agent allergy). 13.Moderate to severe lung disease that significantly affects lung function, including but not limited to any underlying lung disease, such as idiopathic pulmonary fibrosis, autoimmune lung involvement, connective tissue or inflammatory disease, or pneumonectomy. 14.Have a history of non-infectious interstitial lung disease/pneumo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Concentrations of free toxins in subjects after multiple dosing;Incidence of aes leading to treatment termination;Adverse event rate;ADC concentrations in subjects after multiple dosing;PFS;Incidence of AE leading to treatment suspension;The concentration of total plasma antibody after multiple dosing;Duration of Continuous Relief;Incidence of serious adverse events;Disease control rate;Objective Relief Rate; | — |
Countries
China
Contacts
Public ContactCaicun Zhou
Shanghai East Hospital
Outcome results
None listed