Spots Global Cancer Trial Database for A Study of NBL-028 in Patients With Advanced Solid Tumors
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Trial Identification
Brief Title: A Study of NBL-028 in Patients With Advanced Solid Tumors
Official Title: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of NBL-028 in Patients With Advanced Solid Tumors
Study ID: NCT06223256
Conditions
Interventions
Study Description
Brief Summary: This is a multi-center, single agent study conducted in patients with advanced solid tumor types known to express Claudin 6 (CLDN6) for whom standard of care therapies are not available, are no longer effective, or not tolerated. This study consists two stages: dose-escalating and dose-expansion. Dose escalation will be guided by the Bayesian optimal interval (BOIN) design including accelerated titration to determine the maximum tolerated dose (MTD) of NBL-028. Dose expansion - Additional patients (no more than 200) will be enrolled at the recommended dose or multiple doses (if necessary) determined in the dose escalation stage. Sponsor may elect to enroll specific tumor types into four cohorts.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
No.896 East Zhongshan Road, Shijiazhuang, Hebei Province, China., Shijiazhuang, Hebei, China
Contact Details
Name: Ruihua Xu, Ph.D
Affiliation: Sun Yat-Sen University (SYSU) Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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