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.

NCT ID: NCT04671849

Last Updated: 2021-01-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 243 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-21
• Study Completion Date: 2024-01-30

Brief 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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

adult patients_Dose 1

Group Type: EXPERIMENTAL

SIM1803-1A

Intervention Type: DRUG

SIM1803-1A will be administered orally as tablets at a given dose once daily in continuing 21-days cycles.

adult patients_Dose 2

Group Type: EXPERIMENTAL

SIM1803-1A

Intervention Type: DRUG

SIM1803-1A will be administered orally as tablets at a given dose once daily in continuing 21-days cycles.

adult patients_Dose 3

Group Type: EXPERIMENTAL

SIM1803-1A

Intervention Type: DRUG

SIM1803-1A will be administered orally as tablets at a given dose once daily in continuing 21-days cycles.

adult patients_Dose 4

Group Type: EXPERIMENTAL

SIM1803-1A

Intervention Type: DRUG

SIM1803-1A will be administered orally as tablets at a given dose once daily in continuing 21-days cycles.

adult patients_Dose 5

Group Type: EXPERIMENTAL

SIM1803-1A

Intervention Type: DRUG

SIM1803-1A will be administered orally as tablets at a given dose once daily in continuing 21-days cycles.

adult patients_Dose 6

Group Type: EXPERIMENTAL

SIM1803-1A

Intervention Type: DRUG

SIM1803-1A will be administered orally as tablets at a given dose once daily in continuing 21-days cycles.

adult patients_Dose 7

Group Type: EXPERIMENTAL

SIM1803-1A

Intervention Type: DRUG

SIM1803-1A will be administered orally as tablets at a given dose once daily in continuing 21-days cycles.

adult patients_Dose 8

Group Type: EXPERIMENTAL

SIM1803-1A

Intervention Type: DRUG

SIM1803-1A will be administered orally as tablets at a given dose once daily in continuing 21-days cycles.

Interventions

SIM1803-1A

SIM1803-1A will be administered orally as tablets at a given dose once daily in continuing 21-days cycles.

Intervention Type: DRUG

Eligibility 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；

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Simcere Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

shun lu, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Shanghai Chest Hospital

Locations

Shanghai Chest Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

zhen zhou, MD

Role: CONTACT

jenniferzhou1116@163.com

021-22200000

Facility Contacts

zhen zhou, MD

Role: primary

jenniferzhou1116@163.com

021-22200000

Other Identifiers

SIM1803-1A-NTRK-0101

Identifier Type: -

Identifier Source: org_study_id