Overview

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
Trial end date:
2024-01-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Jiangsu Simcere Pharmaceutical Co., Ltd.
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:

- 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;