An Open Label, Multi-center, Phase I Clinical Study to Evaluate the Safety, Effectiveness and Pharmacokinetic Characteristics of SIM1803-1A in Patients With Locally Advanced/Metastatic Solid Tumors With NTRK, ROS1 or ALK Gene Fusion Mutations.
About the study
Who can take part
INCLUSION CRITERIA
Inclusion Criteria:
Adult patients with a locally advanced or metastatic solid tumor that has progressed or was nonresponsive to available therapies, are unfit for standard chemotherapy or for which no standard or available curative therapy exists;Proof of a malignancy harboring a NTRK、ROS1 or ALK fusion;Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 and a life expectancy of at least 3 month;Adequate hematologic, hepatic, and renal function;Signed informed consent form;
EXCLUSION CRITERIA
Exclusion Criteria:
Any contraindications as listed in the local approved product information;Patients with unstable primary central-nervous-system tumors or metastasis, exceptions possible;Pregnancy or lactation;Clinically significant active cardiovascular disease or history of myocardial infarction;Participation in an investigational program with interventions outside of routine clinical practice;Prior treatment with other kinase inhibitor with tropomyosin receptor kinase inhibition;Active uncontrolled systemic bacterial, viral, or fungal infection;Current treatment with a strong CYP3A4 inhibitor or inducer;
Study Locations
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How to Apply
Study’s details
Contition
Advanced or Metastatic Solid Tumors With NTRK, ROS1 or ALK Gene Fusion
Age (in years)
18+
Phase
Phase 1
Participants needed
243
Est. Completion Date
Jan 30, 2024
Treatment type
Interventional
Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
ClinicalTrials.gov identifier
NCT04671849
Study number
SIM1803-1A-NTRK-0101
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