Spots Global Cancer Trial Database for A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Solid Tumor
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Trial Identification
Brief Title: A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic 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 Solid Tumor
Study ID: NCT05194982
Interventions
Study Description
Brief Summary: In phase Ia study, the safety and tolerability of BL-B01D1 in patients with locally advanced or metastatic 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 solid tumor will be evaluated.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Chongqing University Cancer Hospital, Chongqing, Chongqing, China
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China
The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China
Renmin Hospital of Wuhan University, Wuhan, Hubei, China
Union Hospital Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Hunan Cancer Hospital, Changsha, Hunan, China
Shanghai Oriental Hospital, Shanghai, Shanghai, China
Shanxi Cancer Hospital, Taiyuan, Shanxi, China
Contact Details
Name: Li Zhang, PHD
Affiliation: Sun Yat-sen University
Role: PRINCIPAL_INVESTIGATOR
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