Trial Title:
Assessing an Oral EGFR Inhibitor,YK-209A in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR
NCT ID:
NCT05767866
Condition:
Treatment
Treatment Side Effects
Conditions: Keywords:
NSCLC
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
YK-029A
Description:
Daily dose of YK-029A
Arm group label:
Part 1: Dose Escalation Component
Arm group label:
Part 2: Expansion Cohort 1
Arm group label:
Part 2: Expansion Cohort 2
Arm group label:
Part 2: Expansion Cohort 3
Arm group label:
Part 3: ExTension Cohort 4
Arm group label:
Part 3: ExTension Cohort 5
Arm group label:
Part 3: ExTension Cohort 6
Arm group label:
Part 3: ExTension Cohort 7
Arm group label:
Part 3: ExTension Cohort 8
Arm group label:
Part 3: ExTension Cohort 9
Summary:
This study aimed to evaluate the safety and preliminary efficacy of YK-029A, a novel
third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, in
treated or untreated patients with advanced non-small cell lung cancer (NSCLC).
Detailed description:
This phase 1/2 study will evaluate the safety, pharmacokinetics, and anti-tumor activity
of oral EGFR Inhibitor YK-209A in participants with NSCLC and anti-tumor activity of
YK-029A in participants with solid tumors other than NSCLC harboring ex20ins, T790M or
rare mutations. The trial will be conducted in three parts: a dose escalation (Part 1),
expansion phase (Part 2), followed by an extension phase (Part 3).
The objectives of the dose escalation phase (Part 1), is to determine the safety profile
of orally administered YK-029A, including the MTD, DLTs, RP2D, pharmacokinetic profile.
The primary goal of the expansion component of the trial is to evaluate the anti-tumor
activity of YK-029A in nine histologically and molecularly defined cohorts at the RP2D
(determined based on dose escalation phase of the trial).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
General Inclusion Criteria all cohorts: dose escalation, dose expansion, and dose
extension:
1. Have histologically or cytologically confirmed locally advanced or metastatic NSCLC
disease (Stage IIIB or IV) .
2. Male or femal adult，be able to provide a signed and dated, written informed consent.
3. Must have measurable disease by response evaluation criteria in solid tumors
(RECIST) v1.1.
4. Minimum life expectancy of 3 months or more.
5. Adequate organ function at baseline.
6. Normal QT interval on screening electrocardiogram (ECG), defined as QT interval
corrected (Fridericia) (QTcF) of less than or equal to (≤ ) 450 millisecond (ms) in
males or ≤ 470 ms in females.
Part 1: Dose Escalation Cohort Specific Inclusion Criteria:
1. Refractory to standard available therapies.
2. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
3. aged 18-65 years old.
4. previously treated NSCLC patients with EGFR T790M.
Part 2: Expansion Cohort 1、2、3 Specific Inclusion Criteria:
1. previously treated NSCLC patients with EGFR T790M.
2. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
3. aged 18-75 years old.
Part 2: Expansion Cohort 4、5 Specific Inclusion Criteria:
1. previously treated NSCLC patients with EGFR exton 20ins.
2. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
3. aged 18-75 years old.
Part 3: Expansion Cohort 6 Specific Inclusion Criteria:
1. previously untreated NSCLC patients with EGFR exton 20ins.
2. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
3. aged 18-75 years old.
Part 3: Expansion Cohort 7、8 Specific Inclusion Criteria:
1. previously treated NSCLC patients with EGFR rare mutation(（G719X、L861Q、S768I).
2. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
3. aged 18-75 years old.
Part 3: Expansion Cohort9 Specific Inclusion Criteria:
1. previously treated NSCLC patients with EGFR exton 20ins.
2. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
3. aged 18-75 years old.
Exclusion Criteria:
1. Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from a
previous treatment regimen or clinical study within 14 days before screening.
2. Radiotherapy with a limited field of radiation for palliation within 1 week of the
first dose or with a wide field of radiation which must be completed within 4 weeks
before screening.
3. NSCLC patients with EGFR T790M mutation previously treated with third-generation
EGFR-TKIs (such as AZD9291, CO-1686, HM61713, EGF816, PF-06747775, vometinib,
BPI-15086, Ivirtinib maleate, etc.) and their apis or the same drugs in other
clinical trials Drug treatment.
4. Patients with NSCLC with EGFR ex20ins mutation had previously received EGFR ex20ins
inhibitors and/or EGFR-cMET double antibodies (including but not limited to TAK-788,
bociotinib, JNJ-61186372, DZD9008, vometinib, PLB1004, and AZD9291 in excess of the
clinically approved dose (cohort 9 prohibited AZD9291 at any dose) and Drug
substance or other similar drug treatment in the clinical trial stage.
5. NSCLC patients with rare EGFR mutations have previously been treated with
third-generation EGFR-Tkis (such as AZD9291, etc.) and their apis or other similar
drugs in clinical trials.
6. Received a moderate or strong CYP4503A inhibitor or moderate or strong CYP3A inducer
within 10 days prior to first dose of YK-029A.
7. Have significant, uncontrolled, or active cardiovascular disease.
8. Have a known history of uncontrolled hypertension. Participants with hypertension
should be under treatment on study entry to control blood pressure.
9. Have prolonged QTcF interval, or being treated with medications known to be
associated with the development of torsades de pointes.
10. Have an ongoing or active infection, including but not limited to, the requirement
for intravenous (IV) antibiotics, or a known history of human immunodeficiency
virus, hepatitis B virus (HBV), or hepatitis C virus (HCV). Testing is not required
in the absence of history.
11. Currently have or have a history of interstitial lung disease, radiation pneumonitis
that required steroid treatment, or drug-related pneumonitis.
12. Female participants who are lactating and breastfeeding or have a positive urine or
serum pregnancy test during the screening period.
Note: Female participants who are lactating will be eligible if they discontinue
breastfeeding.
13. Have gastrointestinal illness or disorder that could affect oral absorption of
YK-029A.
14. Have any condition or illness that, in the opinion of the investigator, might
compromise participant safety or interfere with the evaluation of the safety of the
drug.
15. Judgment by the investigator that the patient should not participate in the study if
the patient is unlikely to comply with study procedures, restrictions and
requirements.
Gender:
All
Gender based:
Yes
Gender description:
18-75 Years and older (Adult, Older Adult)
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Anhui Provincial Cancer Hospital
Address:
City:
Hefei
Zip:
230000
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhihong Zhang
Phone:
+861891101855
Facility:
Name:
Anhui Provincial Hospital
Address:
City:
Hefei
Zip:
230000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yueyin Pan
Facility:
Name:
The First Affiliated Hospital of Guangzhou Medical University
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Status:
Recruiting
Contact:
Last name:
Chenzhi Zhou
Facility:
Name:
People's Hospital of Guangxi Zhuang Autonomous Region
Address:
City:
Nanjing
Zip:
530000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yanyan Xie
Facility:
Name:
Affiliated Tumor Hospital of Guangxi Medical University
Address:
City:
Nanning
Zip:
530000
Country:
China
Status:
Recruiting
Contact:
Last name:
Qitao Yu
Facility:
Name:
Affiliated Cancer Hospital of Harbin Medical University
Address:
City:
Harbin
Zip:
150000
Country:
China
Status:
Recruiting
Contact:
Last name:
Baogang Liu
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yanqiu Zhao
Facility:
Name:
The First Affiliated Hospital of Zhengzhou University
Address:
City:
Zhenzhou
Zip:
450000
Country:
China
Status:
Recruiting
Contact:
Last name:
Mingjun Li
Facility:
Name:
Renmin Hospital of Wuhan University
Address:
City:
Wuhan
Zip:
430000
Country:
China
Status:
Recruiting
Contact:
Last name:
Qibin Song
Facility:
Name:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430000
Country:
China
Status:
Recruiting
Contact:
Last name:
Kunyu Yang
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410000
Country:
China
Status:
Recruiting
Contact:
Last name:
Lin Wu
Facility:
Name:
Xiangya Hospital Central South University
Address:
City:
Changsha
Zip:
410000
Country:
China
Status:
Recruiting
Contact:
Last name:
Shan Zeng
Facility:
Name:
Jiangsu Province Hospital
Address:
City:
Nanjing
Zip:
210000
Country:
China
Status:
Recruiting
Contact:
Last name:
Bo Shen
Facility:
Name:
Nanjing Chest Hospital
Address:
City:
Nanjing
Zip:
210000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yu Zhang
Facility:
Name:
Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University
Address:
City:
Nanjin
Zip:
210000
Country:
China
Status:
Recruiting
Contact:
Last name:
Liyun Miao
Facility:
Name:
Affiliated Hospital of Xuzhou Medical University
Address:
City:
Xuzhou
Zip:
221000
Country:
China
Status:
Recruiting
Contact:
Last name:
Bi Chen
Facility:
Name:
Xuzhou Central Hospital
Address:
City:
Xuzhou
Zip:
221000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiumei Dai
Facility:
Name:
Jilin Tumor Hospital
Address:
City:
Chang chun
Zip:
130000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yin Chen
Facility:
Name:
First Hospital of Jilin University
Address:
City:
Changchun
Zip:
130000
Country:
China
Status:
Recruiting
Contact:
Last name:
Jiuwei Cui
Facility:
Name:
Liaoning Cancer Hospital and Institute
Address:
City:
Shenyang
Zip:
110000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaoling Li
Facility:
Name:
Shengjing Hospital Affiliated to China Medical University
Address:
City:
Shenyang
Zip:
110000
Country:
China
Status:
Recruiting
Contact:
Last name:
Rong Wu
Facility:
Name:
The First Affiliated Hospital of China Medical University
Address:
City:
ShenYang
Zip:
110000
Country:
China
Status:
Recruiting
Contact:
Last name:
Mingfang Zhao
Facility:
Name:
Shanxi Cancer Hospital
Address:
City:
Taiyuan
Zip:
030000
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianchun Duan
Facility:
Name:
the First Affiliated Hospital; Medical College of Xi'an Jiaotong University
Address:
City:
Xi'an
Zip:
710000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yu Yao
Facility:
Name:
Tianjin Cancer Hospital
Address:
City:
Tianjin
Zip:
300000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiubao Ren
Facility:
Name:
Cancer in Zhejiang Province
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yun Fan
Facility:
Name:
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Status:
Recruiting
Contact:
Last name:
Y Fang
Facility:
Name:
The First Affiliated Hospital of Wenzhou Medical University
Address:
City:
Wenzhou
Zip:
325000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yupin Li
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
10000
Country:
China
Status:
Recruiting
Contact:
Last name:
Li Zhang
Facility:
Name:
Beijing Chest Hospital Affiliated to Capital Medical University
Address:
City:
Beijing
Zip:
100102
Country:
China
Status:
Recruiting
Contact:
Last name:
Jie Liu
Facility:
Name:
Beijing Hospital
Address:
City:
Beijing
Zip:
100102
Country:
China
Status:
Recruiting
Contact:
Last name:
Lin Li
Facility:
Name:
Beijing Tiantan Hospital affiliated to Capital Medical University
Address:
City:
Beijing
Zip:
100102
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaoyan Li
Facility:
Name:
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Address:
City:
Beijing
Zip:
100102
Country:
China
Status:
Recruiting
Contact:
Last name:
Jie Wang, Doctor
Investigator:
Last name:
Jie Wang, Doctor
Email:
Principal Investigator
Investigator:
Last name:
Chunjian Duan, Doctor
Email:
Sub-Investigator
Facility:
Name:
Peking University Cancer Hospital
Address:
City:
Beijing
Zip:
100102
Country:
China
Status:
Recruiting
Contact:
Last name:
Jun Zhao, Doctor
Facility:
Name:
The Fifth Medical Center of the Chinese People's Liberation Army General Hospital
Address:
City:
Beijing
Zip:
100102
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaoqin Liu
Start date:
March 30, 2018
Completion date:
May 30, 2024
Lead sponsor:
Agency:
Suzhou Puhe Pharmaceutical Technology Co., LTD
Agency class:
Industry
Source:
Suzhou Puhe Pharmaceutical Technology Co., LTD
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05767866
