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TreatmentPhase 1/2NCT05767866

Assessing an Oral EGFR Inhibitor,YK-209A in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR

A Phase 1/2 study testing YK-029A in people with Treatment and Treatment Side Effects, run by Suzhou Puhe Pharmaceutical Technology Co., LTD at 35 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Treatment, Treatment Side Effects
What is being tested?
YK-029A
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
35 sitesChina
Study dates
30 Mar 2018to 30 May 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • General Inclusion Criteria all cohorts: dose escalation, dose expansion, and dose extension:
  • Have histologically or cytologically confirmed locally advanced or metastatic NSCLC disease (Stage IIIB or IV) .
  • Male or femal adult，be able to provide a signed and dated, written informed consent.
  • Must have measurable disease by response evaluation criteria in solid tumors (RECIST) v1.1.
  • Minimum life expectancy of 3 months or more.
  • Adequate organ function at baseline.
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  • 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:
  • Refractory to standard available therapies.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
  • aged 18-65 years old.
  • previously treated NSCLC patients with EGFR T790M.
  • Part 2: Expansion Cohort 1、2、3 Specific Inclusion Criteria:
  • previously treated NSCLC patients with EGFR T790M.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
  • aged 18-75 years old.
  • Part 2: Expansion Cohort 4、5 Specific Inclusion Criteria:
  • previously treated NSCLC patients with EGFR exton 20ins.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
  • aged 18-75 years old.
  • Part 3: Expansion Cohort 6 Specific Inclusion Criteria:
  • previously untreated NSCLC patients with EGFR exton 20ins.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
  • aged 18-75 years old.
  • Part 3: Expansion Cohort 7、8 Specific Inclusion Criteria:
  • previously treated NSCLC patients with EGFR rare mutation(（G719X、L861Q、S768I).
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
  • aged 18-75 years old.
  • Part 3: Expansion Cohort9 Specific Inclusion Criteria:
  • previously treated NSCLC patients with EGFR exton 20ins.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
  • aged 18-75 years old.

Who cannot join

  • Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days before screening.
  • 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.
  • 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.
  • 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.
  • 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.
  • Received a moderate or strong CYP4503A inhibitor or moderate or strong CYP3A inducer within 10 days prior to first dose of YK-029A.
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  • Have significant, uncontrolled, or active cardiovascular disease.
  • Have a known history of uncontrolled hypertension. Participants with hypertension should be under treatment on study entry to control blood pressure.
  • Have prolonged QTcF interval, or being treated with medications known to be associated with the development of torsades de pointes.
  • 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.
  • Currently have or have a history of interstitial lung disease, radiation pneumonitis that required steroid treatment, or drug-related pneumonitis.
  • 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.
  • Have gastrointestinal illness or disorder that could affect oral absorption of YK-029A.
  • 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.
  • 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.

Trial locations and contacts

35 sites in 1 country.

Hui Zhao, Doctor contact

+8618911018556

zh@puhebiopharma.com

35 sites in 1 country

China35 sites, 35 recruiting

  • Peking Union Medical College Hospital

    Beijing, 10000

    Li Zhang

    Recruiting

  • Beijing Chest Hospital Affiliated to Capital Medical University

    Beijing, 100102

    Jie Liu

    Recruiting

  • Beijing Hospital

    Beijing, 100102

    Lin Li

    Recruiting

  • Beijing Tiantan Hospital affiliated to Capital Medical University

    Beijing, 100102

    Xiaoyan Li

    Recruiting

  • National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing, 100102

    Jie Wang, Doctor

    Jie Wang, Doctor

    Recruiting

  • Peking University Cancer Hospital

    Beijing, 100102

    Jun Zhao, Doctor

    Recruiting

  • The Fifth Medical Center of the Chinese People's Liberation Army General Hospital

    Beijing, 100102

    Xiaoqin Liu

    Recruiting

  • First Hospital of Jilin University

    Changchun, Jilin, 130000

    Jiuwei Cui

    Recruiting

  • Jilin Tumor Hospital

    Changchun, Jilin, 130000

    Yin Chen

    Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410000

    Lin Wu

    Recruiting

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410000

    Shan Zeng

    Recruiting

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510000

    Chenzhi Zhou

    Recruiting

  • Cancer in Zhejiang Province

    Hangzhou, Zhejiang, 310000

    Yun Fan

    Recruiting

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310000

    Y Fang

    Recruiting

  • Affiliated Cancer Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150000

    Baogang Liu

    Recruiting

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui, 230000

    Zhihong Zhang, +861891101855

    Recruiting

  • Anhui Provincial Hospital

    Hefei, Anhui, 230000

    Yueyin Pan

    Recruiting

  • Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University

    Nanjin, Jiangsu, 210000

    Liyun Miao

    Recruiting

  • People's Hospital of Guangxi Zhuang Autonomous Region

    Nanjing, Guangxi, 530000

    Yanyan Xie

    Recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210000

    Bo Shen

    Recruiting

  • Nanjing Chest Hospital

    Nanjing, Jiangsu, 210000

    Yu Zhang

    Recruiting

  • Affiliated Tumor Hospital of Guangxi Medical University

    Nanning, Guangxi, 530000

    Qitao Yu

    Recruiting

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning, 110000

    Xiaoling Li

    Recruiting

  • Shengjing Hospital Affiliated to China Medical University

    Shenyang, Liaoning, 110000

    Rong Wu

    Recruiting

  • The First Affiliated Hospital of China Medical University

    Shenyang, Liaoning, 110000

    Mingfang Zhao

    Recruiting

  • Shanxi Cancer Hospital

    Taiyuan, Shanxi, 030000

    Jianchun Duan

    Recruiting

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality, 300000

    Xiubao Ren

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

    Yupin Li

    Recruiting

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430000

    Qibin Song

    Recruiting

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430000

    Kunyu Yang

    Recruiting

  • the First Affiliated Hospital; Medical College of Xi'an Jiaotong University

    Xi’an, Shanxi, 710000

    Yu Yao

    Recruiting

  • Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221000

    Bi Chen

    Recruiting

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu, 221000

    Xiumei Dai

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

    Yanqiu Zhao

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhenzhou, Henan, 450000

    Mingjun Li

    Recruiting

Other trials in China

About this study

Official title: Safety and Preliminary Efficacy of YK-029A, a Novel EGFR TKI, in Patients With Advanced NSCLC Harboring ex20ins, T790M or Rare Mutations

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).

Read the 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).

Being tested
YK-029A
Keywords
NSCLC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YK-029ADrug

    Daily dose of YK-029A

Study groups in NCT05767866
Study groupRoleWhat they receive
Part 1: Dose Escalation ComponentExperimentalIn 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).
Receives: Drug: YK-029A
Part 2: Expansion Cohort 1ExperimentalIn 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.
Receives: Drug: YK-029A
Part 2: Expansion Cohort 2ExperimentalIn 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.
Receives: Drug: YK-029A
Part 2: Expansion Cohort 3ExperimentalIn 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.
Receives: Drug: YK-029A
Part 3: ExTension Cohort 4ExperimentalIn 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.
Receives: Drug: YK-029A
Part 3: ExTension Cohort 5ExperimentalIn 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.
Receives: Drug: YK-029A
Part 3: ExTension Cohort 6ExperimentalIn 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.
Receives: Drug: YK-029A
Part 3: ExTension Cohort 7ExperimentalIn 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.
Receives: Drug: YK-029A
Part 3: ExTension Cohort 8ExperimentalIn 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.
Receives: Drug: YK-029A
Part 3: ExTension Cohort 9ExperimentalIn 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.
Receives: Drug: YK-029A

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Number of Participants that Experience Adverse Events (AEs) and Serious Adverse Events (SAEs) .

    To investigate the safety and tolerability of YK-029A when given orally to patients with advanced NSCLC with EGFR T790M.

    Measured: Cycle 1 (Cycle length is equal to [=] 28 days)

  2. Part 1: Number of Participants with Clinically Significant Abnormal Laboratory Values.

    To investigate the safety and tolerability of YK-029A when given orally to patients with advanced NSCLC with EGFR T790M.

    Measured: Cycle 1 (Cycle length is equal to [=] 28 days)

  3. Part 1: Number of Participants with First Cycle Dose-Limiting Toxicities (DLTs).

    To establish Maximum Tolerated Dose (MTD) (if possible) and Recommended Phase 2 Dose (PR2D) of YK-029A when given orally in patients with advanced NSCLC with EGFR T790M mutations.

    Measured: Cycle 1 (Cycle length is equal to [=] 28 days)

  4. Part 1: DLTs of Orally Administered YK-029A.

    Toxicity will be Evaluated According to the NCI CTCAE, Version 5.00. DLT will be defined as any of the events specified in the protocol that are considered by the investigator to be at least possibly related to therapy with study medications.

    Measured: Cycle 1 (Cycle length is equal to [=] 28 days)

  5. Part 1: Number of Participants with First Cycle Dose-Limiting Toxicities (DLTs).

    Toxicity will be evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.00. DLT will be defined as any of the events specified in the protocol that are considered by the investigator to be at least possibly related to therapy with study medications.

    Measured: Cycle 1 (Cycle length is equal to [=] 28 days)

  6. Part 1: Maximum Tolerated Dose (MTD) of Orally Administered YK-029A

    The MTD is the highest dose level at which the participant tolerates treatment without dose-limiting toxicities.

    Measured: Cycle 1 (Cycle length is equal to [=] 28 days)

  7. Part 2: Objective Response Rate (ORR) according to RECIST 1.1 by IRC

    Expansion Cohorts 1、2、3 : Confirmed Objective Response Rate (ORR) Assessed by the Independent Review Committee (IRC)

    Measured: Up to 36 months after first dose

  8. Part 3: Objective Response Rate (ORR) according to RECIST 1.1 by IRC

    xpansion Cohorts 4、5、6、7、8、9 : Confirmed Objective Response Rate (ORR) Assessed by the Independent Review Committee (IRC)

    Measured: Up to 36 months after first dose

Secondary outcomes (12)

  1. Part 1:Cmax: Maximum Plasma Concentration for YK-029A and its Active Metabolites after a Single Oral Dose.

    Measured: Up to 24 hours; Pre-dose and multiple time points post-dose on Cycle 1 Day 1 (C1D1)

  2. Part1:Tmax: Time to Cmax for YK-029A and its Active Metabolites after a Single Oral Dose.

    Measured: Up to 24 hours; Pre-dose and multiple time points post-dose on C1D1

  3. Part1:AUC24: Area Under the Plasma Concentration-Time Curve from Time 0 to 24 hours for YK-029A and its Active Metabolites after a Single Oral Dose

    Measured: Up to 24 hours; Pre-dose and multiple time points post-dose on C1D1

  4. Part1:AUClast: Area Under the Plasma Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration for YK-029A and its Active Metabolites after a Single Oral Dose.

    Measured: Up to 24 hours; Pre-dose and multiple time points post-dose on C1D1

  5. Part1:Cmax, ss: Maximum Plasma Concentration for YK-029A and its Active Metabolites at Steady State after Multiple Oral Doses.

    Measured: Up to approximately 168 days; Pre-dose and multiple time points post-dose.

  6. Part1:Tmax, ss: Time to Cmax for YK-029A and its Active Metabolites at Steady State after Multiple Oral Doses.

    Measured: Up to approximately 168 days; Pre-dose and multiple time points post-dose.

  7. AUC24, ss: Area Under the Plasma Concentration-Time Curve from Time 0 to 24 hours for YK-029A and its Active Metabolites at Steady State after Multiple Oral Doses.

    Measured: Up to approximately 168 days; Pre-dose and multiple time points post-dose.

  8. Part2、3：Overall Response Rate (ORR) as Assessed by the investigator.

    Measured: Up to 36 months after first dose.

  9. Part2、3：Duration of Response (DOR)

    Duration of response is defined as the time interval from the time that the measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that PD is objectively documented.

    Measured: Up to 36 months after first dose.

  10. Part2、3：Disease Control Rate (DCR)

    DCR is defined as the percentage of participants who have achieved CR, PR, or stable disease (SD) (in the case of SD, measurements must have met the SD criteria at least once after study entry at a minimum interval of 42 days) after the initiation of study drug.

    Measured: Up to 36 months after first dose.

  11. Part2、3：Progression Free Survival (PFS)

    PFS is defined as the time interval from the date of randomization until the first date at which the criteria for progressive disease (PD) according to RECIST version 1.1 are met or death, whichever occurs first.

    Measured: Up to 36 months after first dose.

  12. Part2、3：Overall Survival (OS)

    OS is defined as the interval from the date of randomization until death. OS is defined as the interval from the date of randomization until death. OS is defined as the interval from the date of randomization until death.

    Measured: Up to 36 months after first dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2023
  2. Study start30 Mar 2018
  3. Primary completion30 Dec 2023 (estimated)
  4. Study completion30 May 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05767866
Sponsor's protocol ID
HNYK-01
Status last verified
Mar 2023
First submitted
1 Mar 2023
Last updated
17 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37776953

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing YK-029A in people with Treatment and Treatment Side Effects, run by Suzhou Puhe Pharmaceutical Technology Co., LTD at 35 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 32 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hui Zhao, Doctor (+8618911018556, zh@puhebiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Number of Participants that Experience Adverse Events (AEs) and Serious Adverse Events (SAEs) . (time frame: Cycle 1 (Cycle length is equal to [=] 28 days)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05767866, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.

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