Trial Title:
TGRX-326 Chinese Phase II for Advanced Non-small Cell Lung Cancer (NSCLC)
NCT ID:
NCT05955391
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TGRX-326
Description:
Subjects will be treated with the investigational drug TGRX-326 at 60 mg once day in
21-day cycles
Arm group label:
Experimental: TGRX-326
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.
Detailed description:
This Phase II studyaims to evaluate the safety profile and efficacy profile in patients
with ALK-positive advanced NSCLC. The primary purpose of this study is to evaluate the
efficacy profile of TGRX-326, with the objective response rate (ORR) as end point.
Secondary objectives include evaluating efficacy profile of other endpoints and safety
profiles of the investigational drug. Exploratory objective includes the evaluation of
population pharmacokinetic (PK) profile of TGRX-326.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Willing to follow the treatment protocol and visit schedule, and participate in the
study with the ICF signed;
2. ≥ 18 years of age on the day of ICF signing, regardless of gender.
3. With ALK-positive advanced inoperable NSCLC and having disease progression or
intolerance after continuous treatment with second-generation ALK inhibitors;
4. Providing prior ALK positive test results at screening;
5. Patients could have metastases to central nervous system at screening if the
condition is asymptomatic, stable or completely recovered;
6. Drug discontinuation for ≥ 5 half-lives prior to the first dose for subjects
previously treated with ALK inhibitors;
7. At least one measurable lesion;
8. An ECOG PS score within 0-2;
9. Adequate bone marrow, liver, kidney, coagulation and pancreatic functions;
10. Expected survival ≥ 3 months;
11. 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.
Exclusion Criteria:
1. Previous use of any third-generation ALK inhibitors other than TGRX-326;
2. Known hypersensitivity to any of the active ingredients or excipients of TGRX-326 or
a history of severe allergic reactions that makes himself/herself unsuitable for
TGRX-326 treatment in the judgment of the investigator;
3. Having another type of cancer except for lung cancer;
4. Major surgery within 4 weeks prior to the first dose;
5. Spinal cord compression caused by tumor, unless the subject achieves significant
pain control and full recovery of neurological function within 4 weeks prior to the
first dose.
6. Abnormal gastrointestinal function that affect absorption within the past 6 months;
7. History of active pneumonia or clinically significant interstitial pneumonia, or
radiation or drug-induced lung disorder with treatment needs;
8. Cardiac insufficiency;
9. Abnormal and clinically significant QTc on ECG or need of concomitant use of any
drug known to prolong QT interval and cause torsades de pointes;
10. Uncontrolled hypertension after drug treatment;
11. Uncontrolled hyperglycaemia, acute attack of cholelithiasis, and susceptibility to
acute pancreatitis;
12. Severe or uncontrolled systemic diseases causing expected intolerance to the
investigational drug as judged by the investigator;
13. Use within 14 days before the first dose or expected concomitant use during the
treatment period of drugs that pose risk of QTC interval prolongation and/or
ventricular tachycardia;
14. Previous antineoplastic treatments within 28 days prior to the first dose of the
investigational drug;
15. Toxic reactions associated with prior surgery and prior antineoplastic therapies
that have not recovered and may affect the subject safety as assessed by the
investigator.
16. Clinically significant active bacterial, fungal or viral infections, including a
positive result for hepatitis B surface antigen and HBV DNA ≥ ULN, one or more
positive results for hepatitis C antibody or HIV antibody, or the presence of any
uncontrolled infection.
17. Use of strong CYP3A4 inducers or inhibitors or CYP3A4 substrates with a narrow
therapeutic window within two weeks prior to the first dose of the investigational
drug;
18. Pregnant and breastfeeding female;
19. Women of childbearing age who are unwilling or unable to use acceptable methods for
contraception during the entire treatment period in the trial and within 6 months
after the last dose of the investigational drug (women of childbearing age include:
any one with menarche, and those who have not received successful artificial
sterilization [hysterectomy, bilateral fallopian tube ligation, or bilateral
oophorectomy] or premenopausal women); a fertile male patient who is unwilling or
unable to take effective contraceptive measures, and whose partner is a woman of
childbearing age;
20. Being involved in other clinical studies (except for the non-interventional phase of
interventional clinical study, such as survival follow-up period); less than 4 weeks
from the end of the dose of other investigational drug to the first dose of the
investigational drug or 5 half-lives of the previous drug, whichever is shorter;
21. Any mental or cognitive disorders which may limit subjects' understanding and
implementation of the informed consent form;
22. Other situations, such as poor compliance, which are considered by the investigator
to be not suitable for participation in the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Li Zhang, MD
Phone:
+86-020-87343227
Email:
zhangli6@mail.sysu.edu.cn
Start date:
January 18, 2023
Completion date:
August 30, 2024
Lead sponsor:
Agency:
Shenzhen TargetRx, Inc.
Agency class:
Industry
Collaborator:
Agency:
Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
Tongji Hospital
Agency class:
Other
Collaborator:
Agency:
Sichuan Cancer Hospital and Research Institute
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Zhengzhou University
Agency class:
Other
Collaborator:
Agency:
West China Hospital
Agency class:
Other
Collaborator:
Agency:
Zhejiang University
Agency class:
Other
Collaborator:
Agency:
Jilin Provincial Tumor Hospital
Agency class:
Other
Collaborator:
Agency:
Hunan Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Shandong Cancer Hospital and Institute
Agency class:
Other
Collaborator:
Agency:
Jiangxi Provincial Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
First Hospital of China Medical University
Agency class:
Other
Collaborator:
Agency:
The Affiliated Hospital of Qingdao University
Agency class:
Other
Collaborator:
Agency:
Liaoning Tumor Hospital & Institute
Agency class:
Other
Collaborator:
Agency:
Haerbin Medical University Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Xinxiang Central Hospital
Agency class:
Other
Collaborator:
Agency:
Xiangyang Central Hospital
Agency class:
Other
Collaborator:
Agency:
Mianyang Central Hospital
Agency class:
Other
Collaborator:
Agency:
Zhejiang Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Henan Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital, Sun Yat-Sen University
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Bengbu Medical College
Agency class:
Other
Collaborator:
Agency:
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
Agency class:
Other
Collaborator:
Agency:
Bingzhou Medical University Affiliated Hospital
Agency class:
Other
Collaborator:
Agency:
Fujian Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Ningbo No. 1 Hospital
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital Xi'an Jiaotong University
Agency class:
Other
Collaborator:
Agency:
The Second Affiliated Hospital of AFMU
Agency class:
Other
Collaborator:
Agency:
Yunnan Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Capital Medical School Beijing Chest Hospital
Agency class:
Other
Collaborator:
Agency:
Shijiazhuang People's Hospital
Agency class:
Other
Collaborator:
Agency:
Tianjin Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Affiliated Cancer Hospital of Guizhou Medical University
Agency class:
Other
Collaborator:
Agency:
Nanchang University First Affiliated Hospital
Agency class:
Other
Collaborator:
Agency:
Jingzhou First People's Hospital
Agency class:
Other
Collaborator:
Agency:
Shanghai Chest Hospital
Agency class:
Other
Source:
Shenzhen TargetRx, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05955391
