Evaluate the efficacy and safety of SH009 injection therapy for patients with advanced solid tumors
(1) Age≥18 years old at the time of informed consent, male or female;
(2) Subjects with histologically confirmed locally advanced, recurrent, or metastatic solid tumors (including but not limited to colorectal cancer, gastric cancer, hepatocellular carcinoma, head and neck cancer, breast cancer, non-small cell lung cancer, esophageal cancer, etc.) who have experienced disease progression or intolerance to at least one prior line of systemic therapy, and for whom no acceptable standard therapy exists or who cannot benefit from or tolerate standard therapy;
(3) Subjects must have at least one measurable lesion per RECIST 1.1 criteria. A lesion that has been previously irradiated can only be considered measurable if there is documented progression at that site following radiotherapy;
(4) Archival tumor tissue samples are available, or the subject agrees to undergo a tumor biopsy for the determination of PD-L1 and CD47 expression levels and other biomarker analyses;
(1) Prior exposure to any CD47 antibody, SIRPα antibody, or CD47/SIRPα recombinant protein;
(2) Prior treatment with adoptive cellular therapies such as CAR-T, TCR-T, or TIL. Prior administration of an anti-cancer vaccine, or use of live or live-attenuated vaccines within 4 weeks prior to the first dose;
(3) Systemic anti-tumor therapies within the specified timeframes prior to the first dose of study drug: Chemotherapy, antibody-based targeted therapy, endocrine therapy, or immunotherapy within 3 weeks. Mitomycin or nitrosoureas within 6 weeks. Oral fluoropyrimidines (e.g., S-1, capecitabine) and small molecule targeted agents within 2 weeks or 5 half-lives of the drug (whichever is longer).Chinese/herbal medicines with anti-cancer activity indicated in their labeling must be discontinued prior to enrollment. Prior radical radiotherapy within 3 months before study drug administration is excluded. Palliative radiotherapy administered within 2 weeks prior to dosing is allowed if the dose meets local palliative care standards and the radiation field covers less than 30% of the bone marrow area;
(4) Received any investigational drug within 28 days before administration of this trial, or participated in another clinical study at the same time, except for the following circumstances: the patient participated in an observational, non-interventional clinical study, or was in the follow-up period after the end of treatment in an interventional clinical study but the drug withdrawal had exceeded the washout period;
Sequential
SH009
DrugThe dosage of SH009 is 40 mg/kg QW with a treatment cycle of 28 days
Objective response rate (ORR)
Proportion of subjects who have a complete or partial response as assessed according to RECIST v1.1
Duration of response (DoR)
Duration of response (DoR), which is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first
Time to response (TTR)
TTR is defined as the time to response base on RECIST v1.1
Disease control rate (DCR)
Disease control rate (DCR), which is defined as the proportion of subjects with complete response (CR), partial response (PR), or stable disease (SD), based on RECIST v1.1
Percentage of participants with adverse event (AE)
The percentage of participants experiencing an adverse event (AE) and the severity of AEs will be assessed
Observed concentrations of SH009
The endpoints for assessment of Pharmacokinetics (PK) of SH009 include serum concentrations of SH009 at different timepoints after SH009 administration
Number of participants who develop detectable anti-drug antibodies (ADAs)
The immunogenicity of SH009 will be assessed by summarizing the number of participants who develop detectable antidrug antibodies (ADAs)
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