300eP Model-informed drug development (MIDD) to support dose selection of pasritamig, a KLK2xCD3 bispecific antibody, in patients with metastatic castration-resistant prostate cancer (mCRPC)

regimen with standard dosage every 21 days (Anlotinib group) or AG regimen (AG group).Patients achieving CR, PR or SD after 8 cycles of treatment will recieve a nonnab-paclitaxel maintenance treatment.The primary endpoint is ORR.The secondary endpoints include PFS, DCR, and safety. Results:As data cutoff date of September 25, 2025, a total of 43 mPC patients enrolled (28 patients in Anlotinib and 15 in AG group).The median age of were 63 (range 47-74).83.7% (36/43) were ECOG PS 1.The ratio of primary tumor site of pancreatic head, body and tail were 44.2%, 30.2% and 25.6%, respectively.32 patients were tumor assessment available.In Anlotinib Group (N=20), 8 had achieved PR, 10 had SD, and 2 had PD.While in AG group (N=12), 2 had achieved PR, 9 had SD, and 1 had PD.The ORR was 40.0% and 16.7% in each group.The DCR were 90.0% and 91.7%, respectively.The incidence of TEAE were 85.7% and 86.7% in Anlotinib and AG group, respectively.Grade3 TEAE occurred in 32.1% and 33.3% of patients, respectively. Conclusions:The preliminary results had demonstrated a potent efficacy of anlotnib plus benmelstobart and AG as first-line treatment for mPC patients, with a manageable safety profile.Clinical trial identification: NCT06621095.