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.

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


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.

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


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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note