Advanced or Metastatic Solid Tumors With NTRK, ROS1 or ALK Gene Fusion Clinical Trial
Official title:
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.
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.
| Status | Recruiting |
| Enrollment | 243 |
| Est. completion date | January 30, 2024 |
| Est. primary completion date | September 30, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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; |
| Country | Name | City | State |
|---|---|---|---|
| China | Shanghai Chest Hospital | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Jiangsu Simcere Pharmaceutical Co., Ltd. |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of participants with adverse events | Number of participants with adverse events | 5 years | |
| Primary | Severity of adverse events | Severity of adverse events | 5 years | |
| Primary | Maximum tolerated dose | Maximum tolerated dose | 5 years | |
| Primary | Recommended dose for dose expansion | Recommended dose for dose expansion | 5 years | |
| Primary | Maximum concentration of SIM1803-1A in plasma (Cmax) | Maximum concentration of SIM1803-1A in plasma (Cmax) | Predose and 0.25, 0.5, 1, 2, 4, 8,12,24and 48 hours after drug administration on Days 1 and 8 of Cycle 1(each cycle is 21 days) | |
| Primary | Area under the concentration-time curve of SIM1803-1A in plasma from time 0 to 24 hours in fasted state (AUC(0-24)_fasted) | Area under the concentration-time curve of SIM1803-1A in plasma from time 0 to 24 hours in fasted state (AUC(0-24)_fasted) | Up to 1 day | |
| Primary | Area under the concentration-time curve of SIM1803-1A in plasma from time 0 to infinity in fasted state (AUC_fasted) | Area under the concentration-time curve of SIM1803-1A in plasma from time 0 to infinity in fasted state (AUC_fasted) | Up to 3 days | |
| Primary | Number of participants with treatment-emergent adverse events (TEAEs) | Number of participants with treatment-emergent adverse events (TEAEs) | Up to 24 weeks | |
| Primary | Time to maximum concentration of SIM1803-1A in plasma (Tmax) | Time to maximum concentration of SIM1803-1A in plasma (Tmax) | Predose and 0.25, 0.5, 1, 2, 4, 8,12,24and 48 hours after drug administration on Days 1 and 8 of Cycle 1(each cycle is 21 days) | |
| Secondary | Overall Response Rate (ORR) | Overall Response Rate (ORR) | Up to 60 months | |
| Secondary | Duration of Response (DOR) | Duration of Response (DOR) | Up to 60 months | |
| Secondary | progression-free survival(PFS) | progression-free survival(PFS) | Up to 60 months |