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Brief Title: IN10018 Monotherapy and Combination Therapy for Metastatic Melanoma
Official Title: A Phase Ib, Open-label Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of IN10018 as Monotherapy and Combination Therapy in Subjects With Metastatic Melanoma
Study ID: NCT04109456
Brief Summary: This is a phase Ib, open label clinical study to evaluate the safety, tolerability, PK and antitumor activities of IN10018 as monotherapy and in combination with cobimetinib in subjects with metastatic uveal melanoma and NRAS-mutant metastatic melanoma.
Detailed Description: Subjects with metastatic uveal melanoma (UM) or with NRAS-mutant metastatic melanoma will be enrolled. IN10018 will be assessed firstly as monotherapy(Part 1), then in combination with cobimetinib (Part 2) and in combination with cobimetinib and Atezolizumab (Part 3).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Sylvester Comprehensive Cancer Center., Miami, Florida, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Columbia University Medical Center, New York, New York, United States
MD Anderson, Houston, Texas, United States
St Vincent Hospital Sydney, Sydney, New South Wales, Australia
The Alfred Hospital, Melbourne, Victoria, Australia
Linear Clinical Research, Nedlands, Western Australia, Australia
Name: Eddie Xing, Dr.
Affiliation: InxMed Shanghai
Role: STUDY_DIRECTOR