Assessing an Oral EGFR Inhibitor,YK-209A in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR
NCT ID: NCT05767866
Last Updated: 2023-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
160 participants
INTERVENTIONAL
2018-03-30
2024-05-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part 1: Dose Escalation Component
In dose-escalation phase, previously treated patients with EGFR T790M mutation were enrolled. YK-029A was given at doses of 50, 100, 150, 200 to 250 mg/day (3+3 design).
YK-029A
Daily dose of YK-029A
Part 2: Expansion Cohort 1
In dose-escalation phase, previously treated patients with EGFR T790M mutation were enrolled. YK-029A was given at doses of 50mg/day and who have no active, measurable central nervous system (CNS) metastases.
YK-029A
Daily dose of YK-029A
Part 2: Expansion Cohort 2
In dose-escalation phase, previously treated patients with EGFR T790M mutation were enrolled. YK-029A was given at doses of 100mg/day and who have no active, measurable central nervous system (CNS) metastases.
YK-029A
Daily dose of YK-029A
Part 2: Expansion Cohort 3
In dose-escalation phase, previously treated patients with EGFR T790M mutation were enrolled. YK-029A was given at doses of 150mg/day and who have no active, measurable central nervous system (CNS) metastases.
YK-029A
Daily dose of YK-029A
Part 3: ExTension Cohort 4
In dose-extension phase, previously treated patients with EGFR exon 20ins mutation were enrolled. YK-029A was given at doses of 150mg/day and who have no active, measurable central nervous system (CNS) metastases.
YK-029A
Daily dose of YK-029A
Part 3: ExTension Cohort 5
In dose-extension phase, previously treated patients with EGFR exon 20ins mutation were enrolled. YK-029A was given at doses of 200mg/day and who have no active, measurable central nervous system (CNS) metastases.
YK-029A
Daily dose of YK-029A
Part 3: ExTension Cohort 6
In dose-extension phase, previously untreated patients with EGFR exon 20ins mutation were enrolled. YK-029A was given at doses of 200mg/day and who have no active, measurable central nervous system (CNS) metastases.
YK-029A
Daily dose of YK-029A
Part 3: ExTension Cohort 7
In dose-extension phase, previously treated patients with EGFR rare mutation （G719X、L861Q、S768I etal.)were enrolled. YK-029A was given at doses of 150mg/day and who have no active, measurable central nervous system (CNS) metastases.
YK-029A
Daily dose of YK-029A
Part 3: ExTension Cohort 8
In dose-extension phase, previously treated patients with EGFR rare mutation （G719X、L861Q、S768I etal.)were enrolled. YK-029A was given at doses of 200mg/day and who have no active, measurable central nervous system (CNS) metastases.
YK-029A
Daily dose of YK-029A
Part 3: ExTension Cohort 9
In dose-extension phase, previously untreated patients with EGFR exon 20ins mutation were enrolled. YK-029A was given at doses of 150mgBID and who have no active, measurable central nervous system (CNS) metastases.
YK-029A
Daily dose of YK-029A
Interventions
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YK-029A
Daily dose of YK-029A
Eligibility Criteria
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Inclusion Criteria
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.
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.
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.
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.
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.
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.
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Suzhou Puhe Pharmaceutical Technology Co., LTD
INDUSTRY
Responsible Party
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Principal Investigators
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Hui Zhao, Doctor
Role: STUDY_DIRECTOR
Puhe Biopharma
Locations
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Anhui Provincial Cancer Hospital
Hefei, Anhui, China
Anhui Provincial Hospital
Hefei, Anhui, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
People's Hospital of Guangxi Zhuang Autonomous Region
Nanjing, Guangxi, China
Affiliated Tumor Hospital of Guangxi Medical University
Nanning, Guangxi, China
Affiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhenzhou, Henan, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University
Nanjin, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Nanjing Chest Hospital
Nanjing, Jiangsu, China
Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
First Hospital of Jilin University
Changchun, Jilin, China
Jilin Tumor Hospital
Changchun, Jilin, China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, China
Shengjing Hospital Affiliated to China Medical University
Shenyang, Liaoning, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, China
the First Affiliated Hospital; Medical College of Xi'an Jiaotong University
Xi’an, Shanxi, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China
Cancer in Zhejiang Province
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Peking Union Medical College Hospital
Beijing, , China
Beijing Chest Hospital Affiliated to Capital Medical University
Beijing, , China
Beijing Hospital
Beijing, , China
Beijing Tiantan Hospital affiliated to Capital Medical University
Beijing, , China
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, , China
Peking University Cancer Hospital
Beijing, , China
The Fifth Medical Center of the Chinese People's Liberation Army General Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Zhihong Zhang
Role: primary
Yueyin Pan
Role: primary
Chenzhi Zhou
Role: primary
Yanyan Xie
Role: primary
Qitao Yu
Role: primary
Baogang Liu
Role: primary
Yanqiu Zhao
Role: primary
Mingjun Li
Role: primary
Qibin Song
Role: primary
Kunyu Yang
Role: primary
Lin Wu
Role: primary
Shan Zeng
Role: primary
Liyun Miao
Role: primary
Bo Shen
Role: primary
Yu Zhang
Role: primary
Bi Chen
Role: primary
Xiumei Dai
Role: primary
Jiuwei Cui
Role: primary
Yin Chen
Role: primary
Xiaoling Li
Role: primary
Rong Wu
Role: primary
Mingfang Zhao
Role: primary
Jianchun Duan
Role: primary
Yu Yao
Role: primary
Xiubao Ren
Role: primary
Yun Fan
Role: primary
Y Fang
Role: primary
Yupin Li
Role: primary
Li Zhang
Role: primary
Jie Liu
Role: primary
Lin Li
Role: primary
Xiaoyan Li
Role: primary
Jie Wang, Doctor
Role: primary
Jun Zhao, Doctor
Role: primary
Xiaoqin Liu
Role: primary
References
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Duan J, Wu L, Yang K, Zhao J, Zhao Y, Dai X, Li M, Xie Y, Yao Y, Zhao M, Zhou C, Ren X, Liu Z, Pan Y, Li Y, Liu B, Cheng Y, Miao L, Yu Q, Zhang Z, Liu X, Cui J, Zhang Y, Zhang L, Li X, Li X, Shen B, Chen B, Zeng S, Li B, Hu Y, Li L, Wu R, Song Q, Wang J. Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of YK-029A in Treatment-Naive Patients With Advanced NSCLC Harboring EGFR Exon 20 Insertion Mutations: A Phase 1 Trial. J Thorac Oncol. 2024 Feb;19(2):314-324. doi: 10.1016/j.jtho.2023.09.1449. Epub 2023 Sep 28.
Other Identifiers
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HNYK-01
Identifier Type: -
Identifier Source: org_study_id
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