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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.

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About the study

This research study is done to test 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. The cancer must have a change in a particular gene (NTRK1, NTRK2, NTRK3, ROS1 or ALK). SIM1803-1A is a drug that blocks the actions of these NTRK/ ROS1 /ALK genes in cancer cells and can therefore be used to treat cancer.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

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;

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

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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