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CStone Pharmaceuticals (HK:2616)
:2616
Cs2009
Advanced Solid Tumors
Phase I
Recruiting
A Phase I Study of CS2009 in Participants With Advanced Solid Tumors
Dec 15, 2024
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Oxaliplatin, Gemcitabine, Sugemalimab, Pegaspargase
Extranodal Nk/T-Cell Lymphoma
Phase III
Not Yet Recruiting
Study of Sugemalimab (or Placebo) Plus PGemOx Regimen in Participants With Extranodal NK/T-Cell Lymphoma
Jan 17, 2023
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Lorlatinib
Advanced Or Metastatic Ros1-Positive Non-Small Cell Lung Cancer
Phase II
Active Not Recruiting
A Study of Lorlatinib in Subjects With ROS1-Positive Non-Small Cell Lung Cancer
Mar 17, 2022
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Lenalidomide, Oxaliplatin, Gemcitabine, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, Cs5001
Advanced Solid Tumor, Advanced Lymphoma
Phase I
Recruiting
A Study of CS5001 in Patients With Advanced Solid Tumors and Lymphomas
Mar 04, 2022
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Cs1001, Donafenib
Advanced Solid Tumor
Phase I
Unknown
A Study of CS1001 in Combination With Donafenib in Subjects With Advanced Solid Tumors
Jul 08, 2020
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Cs1001
Relapsed Small Cell Lung Cancer
Phase I
Completed
Safety and Tolerability Evaluation of Low-dose Radiation in Combination With CS1001 in Relapsed SCLC Patients
May 29, 2020
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Cs1002
Advanced Solid Tumor
Phase I
Completed
A Phase I Study of CS1002 in Subjects With Advanced Solid Tumors
Mar 31, 2020
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Cs3005
Advanced Solid Tumor
Phase I
Completed
A Study of CS3005 in Advanced Solid Tumors
Jan 15, 2020
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Regorafenib, Cs1001
Advanced Refractory Solid Tumors
Phase I/II
Completed
A Study of CS1001 in Combination With Regorafenib in Patients With Advanced or Refractory Solid Tumors
Dec 13, 2019
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Phase Ib: Fisogatinib (Blu-554) 400Mg In Combination With Sugemalimab (Cs1001) 1200Mg, Phase Ib: Fisogatinib (Blu-554) 600Mg In Combination With Sugemalimab (Cs1001) 1200Mg, Phase Ii: Fisogatinib (Blu-554) 600Mg In Combination With Sugemalimab (Cs1001) 1200Mg
Hepatocellular Carcinoma
Phase I/II
Completed
A Phase Ib/II Study of Fisogatinib(BLU-554) in Subjects With Hepatocellular Carcinoma
Dec 10, 2019
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does CStone Pharmaceuticals (2616) have in its pipeline
2616 is currently developing the following drugs: Cs2009, Oxaliplatin, Gemcitabine, Sugemalimab, Pegaspargase, Lorlatinib. These drug candidates are in various stages of clinical development as the company works toward FDA approval.