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.

Simcere

Status and phase: Unknown; Phase 1

Conditions: Advanced or Metastatic Solid Tumors With NTRK, ROS1 or ALK Gene Fusion

Treatments: Drug: SIM1803-1A

Study type: Interventional

Funder types: Industry

Identifiers

NCT04671849

SIM1803-1A-NTRK-0101

Details and patient eligibility

About

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.

Enrollment: 243 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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；

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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243 participants in 8 patient groups

adult patients_Dose 1

Experimental group

Treatment:

Drug: SIM1803-1A

adult patients_Dose 2

Experimental group

Treatment:

Drug: SIM1803-1A

adult patients_Dose 3

Experimental group

Treatment:

Drug: SIM1803-1A

adult patients_Dose 4

Experimental group

Treatment:

Drug: SIM1803-1A

adult patients_Dose 5

Experimental group

Treatment:

Drug: SIM1803-1A

adult patients_Dose 6

Experimental group

Treatment:

Drug: SIM1803-1A

adult patients_Dose 7

Experimental group

Treatment:

Drug: SIM1803-1A

adult patients_Dose 8

Experimental group

Treatment:

Drug: SIM1803-1A