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Brief Title: Study of HL-085 and Vemurafinib in Metastatic Colorectal Cancer (mCRC)
Official Title: A Phase Ⅱ, Multicenter Open-label Study to Investigate the Efficacy and Safety of HL-085 Combined With Vemurafenib in Patients With Metastatic Colorectal Cancer (mCRC)
Study ID: NCT05233332
Brief Summary: The study consists of the two parts, phase IIa and phase IIb.
Detailed Description: The study consists of the two parts, phase IIa and phase IIb. Phase IIa study is to assess the safety and the antitumor activity in patients with mCRC and to recommend reasonable dosage regimen of HL-085 for phase IIb study. Phase IIb is a pivotal study to evaluate HL-085 plus Vemurafenib in patients with BRAFV600E mCRC whose disease has progressed after 1 or 2 prior regimens in the metastatic setting.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Beijing Oncology Hospital, Beijing, Beijing, China
Name: Hongqi Tian, Ph.D
Affiliation: Shanghai Kechow Pharma, Inc.
Role: STUDY_DIRECTOR