This study was designed to compare the efficacy and safety of IBB0979 in combination with topotecan versus topotecan in subjects with relapsed small cell lung cancer (SCLC).
Aged ≥18 and ≤75 years, male or female.
Histologically confirmed SCLC.
Relapsed small cell lung cancer (limited-stage, extensive-stage) that has failed or progressed after first-line or second-line systemic therapy.
At least one measurable lesion according to RECIST version 1.1.
Combined SCLC, any previous diagnosis of transformed SCLC or SCLC that has transformed to NSCLC.
Known hypersensitivity (≥ Grade 3) to recombinant proteins or any excipient contained in the drug or vehicle formulation for IBB0979.
History of anti-tumor therapy (chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy within 4 weeks) prior to the initiation of investigational product administration.
History of any un-marketed investigational product or therapy within 4 weeks prior to the initiation of investigational product administration.
Parallel
IBB0979
Drugbifunctional antibody-cytokine fusion protein that targets B7-H3 and IL-10 receptor
topotecan hydrochloride for injection
DrugTopotecan hydrochloride will be administered intravenously per prescribing information.
Frequency of adverse events (AEs) and SAEs (Phase II)
To investigate the safety characteristics.
Pharmacokinetic (PK) Cmax (Phase II)
PK parameters (Cmax) following single dose.
Pharmacokinetic (PK) Cmin (Phase II)
PK parameters (Cmin) following single dose.
Pharmacokinetic (PK) Tmax (Phase II)
PK parameters (Tmax) following single dose.
Pharmacokinetic (PK) AUC 0-t (Phase II)
PK parameters (AUC 0-t) following single dose.
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SUNHO（China）BioPharmaceutical CO., Ltd.
Lead sponsor
Zhengzhou University
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
