Spots Global Cancer Trial Database for A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumor and Other Solid Tumor
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Trial Identification
Brief Title: A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumor and Other Solid Tumor
Official Title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-B01D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumor and Other Solid Tumor
Study ID: NCT05262491
Conditions
Interventions
Study Description
Brief Summary: In phase Ia study, the safety and tolerability of BL-B01D1 in patients with locally advanced or metastatic gastrointestinal tumor and other solid tumor will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of BL-B01D1. In phase Ib study, the safety and tolerability of BL-B01D1 at the phase Ia recommended dose will be further investigated, and recommended phase II dose (RP2D) for phase II clinical studies will be determined. In addition, the preliminary efficacy, pharmacokinetic characteristics, and immunogenicity of BL-B01D1 in patients with locally advanced or metastatic gastrointestinal tumor and other solid tumor will be evaluated.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Beijing Cancer Hospital, Beijing, Beijing, China
The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
Jinan Central Hospital, Jinan, Shandong, China
West China Hospital, Sichuan University, Chengdu, Sichuan, China
Tianjin Medical University General Hospital, Tianjin, Tianjin, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Contact Details
Name: Lin Shen, PHD
Affiliation: Peking University Cancer Hospital & Institute
Role: PRINCIPAL_INVESTIGATOR
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