XNW27011 Study of Advanced Solid Tumor Subjects Who Failed Standard Therapies.

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

July 27, 2023

Primary Completion Date

June 30, 2025

Study Completion Date

December 31, 2025

Conditions
Pancreatic Adenocarcinoma MetastaticLung Cancer (NSCLC)Ovarian CancerColorectal Cancer MetastaticBiliary Tract CancerGastric CarcinomaGastroesophageal Junction Adenocarcinoma
Interventions
DRUG

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."

DRUG

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.

Trial Locations (1)

Unknown

RECRUITING

Affiliated Hospital of Shandong First Medical University, Jinan

Sponsors
All Listed Sponsors
lead

Evopoint Biosciences Inc.

INDUSTRY