This study is a prospective, single arm II clinical trial. The main objective of the study is to evaluate the efficacy and safety of the combination of Sacituzumab Tirumotecan (SKB264) and Tagitanlimab (KL-A167) in the treatment of AVPC (aggressive variant prostate cancer) and NEPC (neuroendocrine prostate cancer).
Age at the time of signing the informed consent form is ≥ 18 years old;
AVPC or NEPC diagnosed based on recent histological and/or clinical criteria;
Having received one or two second-generation anti androgen therapies in the past, previous use of docetaxel for castration resistant prostate cancer (CRPC) is allowed, and the use of other chemotherapy is not allowed;
Subjects who have not undergone past surgery must be using and voluntarily continue to use luteinizing hormone releasing hormone (LHRH) agonists throughout the entire study treatment period;
Targeted treatment of TROP2;
Any drug therapy containing targeted topoisomerase I, including antibody conjugated drug (ADC) therapy;
Immune checkpoint inhibitors (such as anti-PD-1/L1 antibodies, anti-CTLA-4 antibodies, etc.), immune checkpoint agonists (such as ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), immune cell therapy, and any other treatment targeting the tumor immune mechanism;
Those who require the use of strong inhibitors or inducers of cytochrome P450 3A4 enzyme (CYP3A4) within 2 weeks prior to the first administration and during the study period (strong inhibitors or inducers of CYP3A4 are not allowed in this study, and representative drugs of CYP3A4 strong inhibitors or inducers are listed in Appendix 7); All subjects must avoid the concurrent use of any drugs, herbal supplements, and/or intake of such foods known to induce CYP3A4 as much as possible;
Single group
Sacituzumab Tirumotecan
DrugDrug reduction will be implemented according to the research plan.
Tagitanlimab
DrugTreatment with Sacituzumab Tirumotecan (SKB264, 5mg/kg IV d1 Q2W) and Tagitanlimab (KL-A167 , 900mg IV d1 Q2W) until confirmed by the investigator as imaging disease progression, intolerable toxicity, subject's request to terminate treatment, or other treatment termination criteria specified in the protocol (based on the first patient), with a maximum treatment duration of 24 months for Tagitanlimab. Drug reduction will be implemented according to the research plan.
Objective Response Rate (ORR)
Objective Response Rate (ORR) assessed according to the evaluation criteria for the efficacy of solid tumors (RECIST v1.1)/ Prostate Cancer Clinical Trials Working Group(PCWG3).
Progression Free Survival(PFS)
The time from the beginning of the patient's treatment to the disease progression or death for any reason. Based on RECIST criteria v1.1/ PCWG3.
Duration of Response(DOR)
Duration of Response, from the first time the evaluation results meet CR or PR criteria to the observation of PD or death.
Disease Control Rate (DCR)
The proportion of subjects with complete response (CR) and partial response (PR) and stable disease (SD) in total subjects after the last subject participating in.
Overall Survival(OS)
Time from start of treatment to death due to any cause.
Exploring predictive effectiveness indicator
Explore potential biomarkers for predicting therapeutic efficacy, including but not limited to immune related indicators such as PD-L1, TILs, lymphocyte subsets, and TROP2 expression.
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Tianjin Medical University Second Hospital
Lead sponsor
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Collaborator
