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Phase I Study of JYP0322 in ROS1 Fusion-Positive Solid Tumors
Sponsor: Guangzhou JOYO Pharma Co., Ltd
Summary
An open, non-randomized, multicenter, single-arm dose-escalation design, phase 1 trial to study the safety, tolerability, pharmacokinetics and efficacy of JYP0322 in patients with ROS1+ locally advanced/metastatic solid tumors .
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of JYP0322 in Patients With Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
101
Start Date
2022-05-04
Completion Date
2027-12-30
Last Updated
2025-07-14
Healthy Volunteers
No
Interventions
JYP0322 50 mg qd
JYP0322 is administered orally at a dose of 50 mg qd for a specified duration until unacceptable toxicity, disease progression, or study completion.
JYP0322 100 mg qd
JYP0322 is administered orally at a dose of 100 mg qd for a specified duration until unacceptable toxicity, disease progression, or study completion.
JYP0322 200 mg qd
JYP0322 is administered orally at a dose of 200 mg qd for a specified duration until unacceptable toxicity, disease progression, or study completion.
JYP0322 100 mg bid
JYP0322 is administered orally at a dose of 100 mg bid for a specified duration until unacceptable toxicity, disease progression, or study completion.
JYP0322 150 mg bid
JYP0322 is administered orally at a dose of 150 mg bid for a specified duration until unacceptable toxicity, disease progression, or study completion.
JYP0322 200 mg bid
JYP0322 is administered orally at a dose of 200 mg bid for a specified duration until unacceptable toxicity, disease progression, or study completion.
JYP0322 150mg tid
JYP0322 is administered orally at a dose of 150 mg tid for a specified duration until unacceptable toxicity, disease progression, or study completion.
Locations (1)
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China