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The Phase I Study of SIG001 Antibody on Cancer Therapy.

StatusNot Yet Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
The goal of this clinical trial is to learn the safty characteristics of SIG001 Mab in cancer patients; It will also determine the Recommended Phase II dose of SIG001 Mab on cancer treatment, and pharmacological characteristics of SIG001. The main questions it aims to answer are: What is the safety and tolerability of SIG001 in patients with advanced solid tumors ? What is the Recommended Phase II dose of SIG001? What is the PK/PD characteristics of SIG001 in cancer patients? What is the antitumor activity of SIG001 in cancer patients? What is the immunogenicity of SIG001 in cancer patients? What is the relationship between the exposure/dose of SIG001 and its safety as well as clinical efficacy? What is the expression levels of potential biomarkers (such as SIG), if applicable, and analyze their correlation with drug exposure, efficacy, and safety? What is event-related endpoints such as the Duration of Response and Progression-Free Survival in patients treated with SIG001? This will be a single-armed study. Participants will: Intravenously Inject SIG001 every two weeks, for 4 weeks Visit the clinic on the 14th day, 30th day, and 90th day afer the last injection. Then visit the clinic for every 12 weeks.
Trial Details
NCT Number NCT07486700
Lead Sponsor Peking University
Collaborators: Peking Union Medical College Hospital, First Affiliated Hospital of Zhejiang University, Tianjin Medical University Cancer Institute and Hospital, Guangzhou SIG Biomedical Technology Co., Ltd., Peking University Cancer Hospital & Institute
Conditions
(from sponsor)		 Neoplams
Enrollment 66 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov