240
Participants
Start Date
July 27, 2023
Primary Completion Date
June 30, 2025
Study Completion Date
December 31, 2025
XNW27011
"Eligible patient(s) in each dose cohort will receive the assigned XNW27011 dose administration every 3 weeks (Q3W, cycle) until intolerable toxicity, progression of the disease without clinical benefit, or withdrawal of informed consent.~An accelerated titration scheme will be used for the first two dose levels (0.6 mg/kg and 1.2 mg/kg) starting from 0.6 mg/kg dose as follows:~The first patient will be enrolled for 0.6 mg/kg dose. If the subject shows no significant toxicity in cycle 1 (DLT observation period), the second patient will be enrolled for 1.2 mg/kg.~3 + 3 dose escalation:3 patients will be enrolled to the dose cohort first,If 1 of 3 patients experiences a DLT, up to 3 more patients will be enrolled in the same dose cohort.. If none of the additional 3 patients experiences a DLT, dose escalation will continue to the next dose.Dose escalation will be stopped when 2 or more patients out of 3 to 6 patients at the same dose level experience a DLT."
XNW27011
Group A: Gastric/gastroesophageal junction adenocarcinoma with CLDN18.2 expression, tentatively expand with 3.6, 3.0, 2.4 mg/kg. Group B: Pancreatic adenocarcinoma with CLDN18.2 expression, tentatively expand with 3.6, 3.0, 2.4 mg/kg. Group C: Ovarian cancer with CLDN18.2 expression, tentatively expand with 3.6, 3.0, 2.4 mg/kg. Group D: Other tumors with CLDN18.2 expression, including but not limited to esophagus adenocarcinoma, lung cancer, colorectal cancer, and biliary tract cancer,tentatively expand with 3.6, 3.0, 2.4 mg/kg.
RECRUITING
Affiliated Hospital of Shandong First Medical University, Jinan
Lead Sponsor
Evopoint Biosciences Inc.
INDUSTRY