A Multi-centered, Open-label, Single-arm Phase II Study to Evaluate the Safety and Efficacy of TGRX-326 Monotherapy in Patients of Advanced ALK-positiveNon-Small Cell Lung Cancer Who Failed 2nd-Generation ALK Inhibitor Therapies

Status: Active_not_recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a multi-center, single-arm, open-label, Phase II clinical trial which explores the safety and efficacy of TGRX-326 in patients with ALK-positive advanced NSCLC who have failed prior 2nd-generation ALK treatments due to progressive disease or intolerance.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Willing to follow the treatment protocol and visit schedule, and participate in the study with the ICF signed;

• ≥ 18 years of age on the day of ICF signing, regardless of gender.

• With ALK-positive advanced inoperable NSCLC and having disease progression or intolerance after continuous treatment with second-generation ALK inhibitors;

• Providing prior ALK positive test results at screening;

• Patients could have metastases to central nervous system at screening if the condition is asymptomatic, stable or completely recovered;

• Drug discontinuation for ≥ 5 half-lives prior to the first dose for subjects previously treated with ALK inhibitors;

• At least one measurable lesion;

• An ECOG PS score within 0-2;

• Adequate bone marrow, liver, kidney, coagulation and pancreatic functions;

⁃ Expected survival ≥ 3 months;

⁃ Willing to take effective contraceptive measures (for men of reproductive potential and women of reproductive age only) from ICF signing to 6 months after administration of the investigational drug. Women of reproductive age include women before menopause and within 2 years after menopause. Those women must have a negative pregnancy test ≤ 7 days prior to the first dose of the investigational drug.

Locations
Other Locations
China
Sun Yat-sen University Cancer Center
Guangzhou
Time Frame
Start Date: 2023-01-18
Completion Date: 2025-12-31
Participants
Target number of participants: 164
Treatments
Experimental: Experimental: TGRX-326
Subjects to be treated with the investigational drug TGRX-326 at 60 mg once day in 21-day cycles.
Sponsors
Collaborators: Liaoning Cancer Hospital & Institute, Jiangxi Provincial Cancer Hospital, Shandong Cancer Hospital and Institute, Shijiazhuang People's Hospital, West China Hospital, Henan Cancer Hospital, Mianyang Central Hospital, Ningbo No. 1 Hospital, Haerbin Medical University Cancer Hospital, Sichuan Cancer Hospital and Research Institute, Jilin Provincial Tumor Hospital, The Second Affiliated Hospital of AFMU, Affiliated Cancer Hospital of Guizhou Medical University, Zhejiang Cancer Hospital, Nanchang University First Affiliated Hospital, Tongji Hospital, Xinxiang Central Hospital, Fujian Cancer Hospital, Hunan Cancer Hospital, Shanghai Chest Hospital, First Affiliated Hospital Xi'an Jiaotong University, Yunnan Cancer Hospital, Bingzhou Medical University Affiliated Hospital, The Affiliated Hospital of Qingdao University, First Affiliated Hospital, Sun Yat-Sen University, First Hospital of China Medical University, First Affiliated Hospital of Bengbu Medical College, Capital Medical School Beijing Chest Hospital, The First Affiliated Hospital of Zhengzhou University, Tianjin Cancer Hospital, Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center, Zhejiang University, Sun Yat-sen University, Xiangyang Central Hospital, Jingzhou First People's Hospital
Leads: Shenzhen TargetRx, Inc.

This content was sourced from clinicaltrials.gov