Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Phase Ib/II Study Of JS015 Combination Therapy in Advanced Solid Tumors
Sponsor: Shanghai Junshi Bioscience Co., Ltd.
Summary
This is a phase Ib/II, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of JS015 combination therapy in patients with advanced solid tumors. The Recommended dose for phase II trial (RP2D) will be determined based on the safety, tolerability, pharmacokinetics and efficacy.
Official title: A Phase Ib/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of JS015 Combination Therapy in Patients With Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
186
Start Date
2024-01-03
Completion Date
2026-01-28
Last Updated
2024-12-20
Healthy Volunteers
No
Conditions
Interventions
JS015
JS015 will be administered intravenously (IV) on days 1 and 15 every 28 day cycle, or day 1 every 21 day cycle, based on different combined chemotherapy.
Toripalimab
Toripalimab will be administered intravenously (IV) on day 1 every 21 day cycle.
Paclitaxel
Paclitaxel will be administered intravenously (IV) on day 1 every 21 day cycle.
Irinotecan
Irinotecan will be administered intravenously (IV) on days 1 and 15 every 28 day cycle.
Capecitabine
Capecitabin will be administered orally twice daily from day 1 to 14 every 21 day cycle.
Oxaliplatin
Oxaliplatin will be administered intravenously (IV) on day 1 every 21 day cycle.
Bevacizumab
Bevacizumab of 5mg/kg will be administered intravenously (IV) on days 1 and 15 every 28 day cycle, or7.5mg/kg on day 1 every 21 day cycle, based on different combined chemotherapy.
Fluorouracil
Fluorouracil will be administered intravenously (IV) on days 1 and 15 every 28 day cycle.
Leucovorin
Leucovorin will be administered intravenously (IV) on days 1 and 15 every 28 day cycle.
Gemcitabine
Gemcitabine will be administered intravenously (IV) on days 1 and 8 every 21 day cycle.
Albumin-Bound Paclitaxel
Albumin-bound paclitaxel will be administered intravenously (IV) on days 1 and 8 every 21 day cycle.
Locations (1)
Shanghai East Hospital
Shanghai, Shanghai Municipality, China