Spots Global Cancer Trial Database for A Study to Evaluate YH001 in Combination With Toripalimab in Subjects With Advanced NSCLC and HCC
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Trial Identification
Brief Title: A Study to Evaluate YH001 in Combination With Toripalimab in Subjects With Advanced NSCLC and HCC
Official Title: An Open-Label, Non-Randomized, Multi-center Phase 2 Study of YH001 in Combination With Toripalimab in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC) and Hepatocellular Carcinoma (HCC)
Study ID: NCT05212922
Interventions
Study Description
Brief Summary: This is an Open-label, Non-Randomized, Multi-center Phase 2 study of YH001 in Combination with Toripalimab，The study is designed to determine the safety ，tolerability and antitumor activity of YH001 in combination with Toripalimab in subjects with advanced NSCLC and HCC.
Detailed Description: This study will include two cohorts of up to 40 subjects each treated with RP2D dose YH001 in combination with 240 mg Toripalimab to assess the antitumor activity and safety/tolerability. According to Simon's two stage design, in the first stage, 9-10 subjects will be accrued. If there are ≤ 1 subjects achieving an objective response, the futility stop will be called. Enrollment will start for the second stage after Stage 1 data pass futility test. In the second stage, 17-19 subjects will be enrolled to have 27 subjects in total. If there are ≥ 5 subjects achieving an objective response, a stop could be called for meeting the primary objective. In all cohorts, 4 mg/kg or other higher dose level of YH001 (not exceeding MTD) may be needed based on the safety data in the first stage. * Cohort A: YH001 in combination with Toripalimab in subjects with advanced PD-L1 positive NSCLC as 1st line treatment; * Cohort B: YH001 in combination with Toripalimab in subjects with previously systemically treated advanced HCC as 2nd line treatment;
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Gabrail Cancer Center Research, Canton, Ohio, Armenia
University of New South Wales (UNSW) - Liverpool Hospital, Liverpool, New South Wales, Australia
Andrew Love Cancer Centre, Geelong, Victoria, Australia
Coffs Harbour Health Campus, Coffs Harbour, New South Wales, Austria
Beijing Cancer Hospital, Beijing, Beijing, China
Beijing Tsinghua Changgung Hospital, Beijing, Beijing, China
The Affiliated Tumour Hospital of Harbin Medical University, Harbin, Heilongjiang, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China
Hubei Cancer Hospital, Wuhan, Hubei, China
Nantong Tumor Hospital, Nantong, Jiangsu, China
Bethune First Hospital Of Jilin University, Changchun, Jilin, China
Shanghai Pulmonary Hospital, Shanghai, Shanghai, China
West China Hospital of Sichuan University, Chengdu, Sichuan, China
Sir Run Run Shaw Hospital Zhejiang University School Of Medicine, Hangzhou, Zhejiang, China
Kaohsiung Medical University - Chung-Ho Memorial Hospital, Kaohsiung, , Taiwan
Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
Chi Mei Medical Center - YongKang, Tainan, , Taiwan
Chi Mei Medical Center - Liouying, Tainan, , Taiwan
Taipei Medical University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Contact Details
Name: Rong Chen, Ph.D
Affiliation: Eucure (Beijing) Biopharma Co., Ltd
Role: STUDY_CHAIR
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