This study is to evaluate a novel cytotoxic anti-PD-L1, IUAb190708, for the treatment of tumor
Male or female adult, age 18 - 75, understanding and voluntarily signing an informed consent form
A histologically confirmed diagnosis of Metastatic or locally advanced solid tumors, ineffective management of therapeutic regimen or currently no approved treatment available for the tumor, or unsuitable or refusing to receive standard treatment
In Phase Ia, for tumors with approved indications of anti PD-1/PD-L1 treatment, unrestricted to PD-L1 expression; for tumors that have not yet been approved for indications, positive expression of PD-L1 required. In Phase Ib, positive expression of PD-L1 is required
Subjects should provide fresh or archived tissue samples
Serious/active infection or infection requiring intravenous antibiotic treatment within 4 weeks prior to the first dose of the study drug
Receiving nitrosourea and mitomycin C within 6 weeks prior to the first dose of the study drug; receiving oral fluorouracil derivatives or small molecule targeted drugs within 2 weeks prior to the first dose or 5 half-lives of the drug (whichever is longer); receiving endocrine therapy, Immunotherapy, or Traditional Chinese Medicine for anti-tumor indications within 2 weeks prior to the first dose of the study drug; receiving other anti-tumor therapies, such as chemotherapy, radiation, biotherapy, besides as described above treatments, within 4 weeks prior to the first dose of the study drug
Having other primary active malignant tumors within 5 years prior to the first dose of the study drug
Having clinically significant cardiovascular diseases,
Single group
IUAb190708, a cytotoxic antibody
Druga novel cytotoxic anti-PD-L1 antibody
ORR
Objective response rate (ORR), defined as the number of subjects with complete response (CR) or partial response (PR) divided by the number of subjects in the population of interest.
DOR
Duration of Objective Response (DOR), defined as the time between the date of first response and the subsequent date of objectively documented disease progression or death, whichever occurs first.
PFS
Progressive free survival (PFS), defined as the time between date of first dose of study therapy and date of progression or death, whichever occurs first.
OS
Overall survival (OS), defined as the time between the date of first dose of study therapy and the date of death.
Incidence and severity of adverse events (AEs)
Severity is determined based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE Version 5.0)
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Jun Zhou
Lead sponsor
ImmunoUrchin
Sponsor institution
Fudan University
Collaborator
Hunan Cancer Hospital
Collaborator
Fujian Cancer Hospital
Collaborator
Shanghai Pulmonary Hospital, Shanghai, China
Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
Shandong Cancer Hospital and Institute
Collaborator
Anyang Tumor Hospital
Collaborator
