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.

  • STATUS
    Recruiting
  • End date
    Jan 30, 2024
  • participants needed
    243
  • sponsor
    Jiangsu Simcere Pharmaceutical Co., Ltd.
Updated on 30 January 2021

Summary

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.

Details
Condition Advanced or Metastatic Solid Tumors With NTRK, ROS1 or ALK Gene Fusion, Advanced or Metastatic Solid Tumors With NTRK, ROS1 or ALK Gene Fusion
Treatment SIM1803-1A
Clinical Study IdentifierNCT04671849
SponsorJiangsu Simcere Pharmaceutical Co., Ltd.
Last Modified on30 January 2021

Eligibility

Yes No Not Sure

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 existsProof of a malignancy harboring a NTRKROS1 or ALK fusionEastern Cooperative Oncology Group (ECOG) score of 0 or 1 and a life expectancy of at least 3 monthAdequate hematologic, hepatic, and renal functionSigned informed consent form

Exclusion Criteria

Any contraindications as listed in the local approved product informationPatients with unstable primary central-nervous-system tumors or metastasis, exceptions possiblePregnancy or lactationClinically significant active cardiovascular disease or history of myocardial infarctionParticipation in an investigational program with interventions outside of routine clinical practicePrior treatment with other kinase inhibitor with tropomyosin receptor kinase inhibitionActive uncontrolled systemic bacterial, viral, or fungal infectionCurrent treatment with a strong CYP3A4 inhibitor or inducer
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