EGFR Gene MutationPhase 1/2NCT03046992
Clinical Trial of YH25448 in Patients with EGFR Mutation Positive Advanced NSCLC
A Phase 1/2 study testing YH25448 in people with EGFR Gene Mutation, run by Yuhan Corporation at 16 sites in South Korea.
Trial summary
YH25448 is an oral, highly potent, mutant-selective and irreversible EGFR Tyrosine-kinase inhibitors (TKIs) targets both the T790M mutation and activating EGFR mutations while sparing wild type-EGFR. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- EGFR Gene Mutation
- What is being tested?
- YH25448
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 16 sitesSouth Korea
- Study dates
- 15 Feb 2017to 30 Mar 2023
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed diagnosis of NSCLC with single activating EGFR mutations.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 3 months.
- At least one measurable extracranial lesion, not previously irradiated and not chosen biopsy during the study screening period.
- Prior to enrolling in the study, patients must have central confirmation of T790M+ mutation status from a sample taken after documented progression on the EGFR-TKIs therapy according to cohort.
Who cannot join
- Spinal cord compression.
- Brain metastases with symptomatic and/or requiring steroid for at least 2 weeks prior to start of study treatment.
- Known intracranial hemorrhage which is unrelated to tumor.
- Central Nervous System (CNS) complications that require urgent neurosurgical intervention (e.g. resection or shunt placement).
- Leptomeningeal metastasis prior to study treatment.
- Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
Show all 10Show fewer
- Any cardiovascular disease as followed.
- History of symptomatic congestive heart failure (CHF) or serious cardiac arrhythmia requiring treatment
- History of myocardial infarction or unstable angina within 6 months of the first dose of study treatment
- Left ventricular ejection fraction (LVEF) < 50%
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
South Korea16 sites
The Catholic University of Korea, Bucheon St. Mary's Hospital
Bucheon-si, Gyeonggi-do, 14647
Inje University Haeundae Paik Hospital
Busan, 48108
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, 28644
National Cancer Center
Goyang-si, Gyeonggi-do, 03080
Gachon University Gil Medical Center
Incheon, 21565
Gyeongsang National University Hospital
Jinju, Gyeongsangnam-do, 52727
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, 13496
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Seoul National University Hospital
Seoul, 03080
Kangbuk Samsung Hospital
Seoul, 03181
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
SMG-SNU Boramae Medical Center
Seoul, 07061
Severance Hospital
Seoul
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, 16247
Ulsan University Hospital
Ulsan, 44033
About this study
Official title: A Phase I/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Tumor Activity of YH25448 in Patients with EGFR Mutation Positive Advanced Non-Small Cell Lung Cancer (NSCLC)
YH25448 is an oral, highly potent, mutant-selective and irreversible EGFR Tyrosine-kinase inhibitors (TKIs) targets both the T790M mutation and activating EGFR mutations while sparing wild type-EGFR. YH25448 is expected to beneficial for the NSCLC patients with brain metastasis due to good blood brain barrier (BBB) penetration property as well as for the treatment of primary lung lesion and extracranial lesions. This study will be conducted to evaluate the safety, tolerability and efficacy of YH25448 in locally advanced or metastatic NSCLC patients with EGFR mutations.
Read the detailed description
This is a first time in patient study primarily designed to evaluate the safety, tolerability, and efficacy of YH25448 in in patients with EGFR mutation positive (EGFRm+) advanced NSCLC with or without asymptomatic brain metastasis who progressed following prior therapy with an EGFR TKIs agent. This study is composed of 3 parts; part A is a dose escalation phase, part B is a dose expansion phase and part C is a dose extension phase.
In dose escalation phase, YH25448 will be escalated to reach either a maximum tolerated or absorbable dose in patients as defined by dose-limiting toxicity in NSCLC patients who progressed following prior EGFR TKIs treatment to evaluate the safety and tolerability. In dose expansion phase, further safety, tolerability, pharmacokinetic(PK) and efficacy will be evaluated at each dose level(s) of dose escalation phase in NSCLC patients who progressed following prior EGFR TKIs treatment and harbouring confirmed T790M mutation. In dose extension phase, additional 2 cohorts (2nd line therapy cohort, 1st line therapy cohort) will be enrolled to further assess the efficacy, safety, tolerability, and PK of YH25448 at the maximum tolerated dose (MTD) or recommended dose (RD) defined through dose escalation phase and dose expansion phase. Results of these studies will serve as the evidence for further clinical development.
This study will also characterize the metabolite(s) profile of YH25448 and determine PK of its metabolite(s) in biological samples if necessary. Also, exploratory correlation between biomarker profiles and pharmacokinetics/pharmacodynamics will be analyzed.
- Conditions
- EGFR Gene Mutation
- Being tested
- YH25448
- Keywords
- EGFR, Non-Small Cell Lung Cancer, T790M, Brain Metastasis
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YH25448Drug
- Dose Escalation: YH25448 20mg~320mg, PO
- Dose Expansion: YH25448 40mg~240mg, PO
- Dose Extension: Recommended Dose 240mg of YH25448
| Study group | Role | What they receive |
|---|---|---|
| YH25448 | Experimental | * Dose Escalation Phase: Consists of 7 Cohorts
* Dose Expansion Phase: Consists of 5 Cohorts
* Dose Extension Phase: Consists of 2 Cohorts Receives: Drug: YH25448 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability by Common Terminology Criteria for Adverse Events (CTCAE) v4.03
To assess the safety and tolerability profile of YH25448 by Common Terminology Criteria for Adverse Events (CTCAE) v4.03; vital signs (blood pressure, pulse, weight); laboratory parameters (clinical chemistry, hematology, urinalysis); physical examination; centrally reviewed electrocardiograms (ECGs), echocardiogram or multiple gated acquisition scan and performance status.
Measured: Safety and tolerability profile will be collected from baseline until 28 days after the last dose, expected average 1 year.
Objective Response Rate (ORR)
Per Response Evaluation Criteria in Solid Tumours (RECIST version 1.1) assessed by MRI or CT. ORR is the percentage of patients with at least 1 visit response of Complete Response (CR) or Partial Response (PR) (according to independent review), prior to progression or further anti-cancer therapy.
Measured: At baseline and every 6 weeks from first dose objective disease progression or withdrawal from study, up to approximately 1 year.
Secondary outcomes (8)
Duration of Response (DoR)
Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT.
Measured: At baseline and every 6 weeks from first dose objective disease progression or withdrawal from study, up to approximately 1 year.
Disease Control Rate (DCR)
Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT.
Measured: At baseline and every 6 weeks from first dose objective disease progression or withdrawal from study, up to approximately 1 year.
Progression-Free Survival (PFS)
Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT. Kaplan-Meier plots will be used to summarize the progression-free survival.
Measured: At baseline and every 6 weeks from first dose objective disease progression or withdrawal from study, up to approximately 1 year.
Overall Survival (OS)
To obtain assessment of anti-tumor activity of YH25448 by evaluation of tumor response using RECIST version 1.1.
Measured: At baseline and every 6 weeks from first dose objective disease progression or withdrawal from study, up to approximately 1 year.
Tumor shrinkage
To obtain assessment of anti-tumor activity of YH25448 by evaluation of tumor response using RECIST version 1.1.
Measured: At baseline and every 6 weeks from first dose objective disease progression or withdrawal from study, up to approximately 1 year.
Objective Intracranial Response Rate (OIRR)
To obtain assessment of anti-tumor activity of YH25448 by evaluation of tumor response using RECIST version 1.1.
Measured: At baseline and every 6 weeks from first dose objective disease progression or withdrawal from study, up to approximately 1 year.
Duration of Intracranial Response (DoIR)
To obtain assessment of anti-tumor activity of YH25448 by evaluation of tumor response using RECIST version 1.1.
Measured: At baseline and every 6 weeks from first dose objective disease progression or withdrawal from study, up to approximately 1 year.
Intracranial Progression Free Survival (IPFS).
To obtain assessment of anti-tumor activity of YH25448 by evaluation of tumor response using RECIST version 1.1. Kaplan-Meier plots will be used to summarize the progression-free survival.
Measured: At baseline and every 6 weeks from first dose objective disease progression or withdrawal from study, up to approximately 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start15 Feb 2017
- Primary completion8 Jan 2021
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for EGFR Gene MutationStudies of the same condition, open and under way.
- More trials run by Yuhan CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuhan Corporation, Study director, Clinical Development Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03046992
- Sponsor's protocol ID
- YH25448-201
- Status last verified
- Apr 2023
- First submitted
- 26 Jan 2017
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Han JY, Ahn MJ, Lee KH, Lee YG, Kim DW, Min YJ, Kim SW, Cho EK, Kim JH, Lee GW, Lee SS, Lee NM, Jang HW, Han H, Park H, Lee J, Cho BC. Updated overall survival and ctDNA analysis in patients with EGFR T790M-positive advanced non-small cell lung cancer treated with lazertinib in the phase 1/2 LASER201 study. BMC Med. 2024 Oct 8;22(1):428. doi: 10.1186/s12916-024-03620-8.
PubMed 39379931Kim B, Lee J, Jang H, Lee N, Mehta J, Jang SB. Effects of Acid-Reducing Agents on the Pharmacokinetics of Lazertinib in Patients with EGFR Mutation-Positive Advanced Non-Small-Cell Lung Cancer. Adv Ther. 2022 Oct;39(10):4757-4771. doi: 10.1007/s12325-022-02286-z. Epub 2022 Aug 13.
PubMed 35962934Cho BC, Han JY, Kim SW, Lee KH, Cho EK, Lee YG, Kim DW, Kim JH, Lee GW, Lee JS, Shim BY, Kim JS, Chun SH, Lee SS, Kim HR, Hong MH, Ahn JS, Sun JM, Lee Y, Lee DH, Kang JA, Lee N, Kwon MJ, Espenschied C, Yablonovitch A, Ahn MJ. A Phase 1/2 Study of Lazertinib 240 mg in Patients With Advanced EGFR T790M-Positive NSCLC After Previous EGFR Tyrosine Kinase Inhibitors. J Thorac Oncol. 2022 Apr;17(4):558-567. doi: 10.1016/j.jtho.2021.11.025. Epub 2021 Dec 24.
PubMed 34958928Ahn MJ, Han JY, Lee KH, Kim SW, Kim DW, Lee YG, Cho EK, Kim JH, Lee GW, Lee JS, Min YJ, Kim JS, Lee SS, Kim HR, Hong MH, Ahn JS, Sun JM, Kim HT, Lee DH, Kim S, Cho BC. Lazertinib in patients with EGFR mutation-positive advanced non-small-cell lung cancer: results from the dose escalation and dose expansion parts of a first-in-human, open-label, multicentre, phase 1-2 study. Lancet Oncol. 2019 Dec;20(12):1681-1690. doi: 10.1016/S1470-2045(19)30504-2. Epub 2019 Oct 3.
PubMed 31587882Yun J, Hong MH, Kim SY, Park CW, Kim S, Yun MR, Kang HN, Pyo KH, Lee SS, Koh JS, Song HJ, Kim DK, Lee YS, Oh SW, Choi S, Kim HR, Cho BC. YH25448, an Irreversible EGFR-TKI with Potent Intracranial Activity in EGFR Mutant Non-Small Cell Lung Cancer. Clin Cancer Res. 2019 Apr 15;25(8):2575-2587. doi: 10.1158/1078-0432.CCR-18-2906. Epub 2019 Jan 22.
PubMed 30670498
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Tumor Activity of YH25448 in Patients with EGFR Mutation Positive Advanced Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT03046992
- Acronym / sponsor ID
- YH25448-201
- Conditions
- EGFR Gene Mutation
- Keywords
- EGFR, Non-Small Cell Lung Cancer, T790M, Brain Metastasis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 8 Jan 2021 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 8 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
YH25448 is an oral, highly potent, mutant-selective and irreversible EGFR Tyrosine-kinase inhibitors (TKIs) targets both the T790M mutation and activating EGFR mutations while sparing wild type-EGFR. YH25448 is expected to beneficial for the NSCLC patients with brain metastasis due to good blood brain barrier (BBB) penetration property as well as for the treatment of primary lung lesion and extracranial lesions. This study will be conducted to evaluate the safety, tolerability and efficacy of YH25448 in locally advanced or metastatic NSCLC patients with EGFR mutations.
Detailed description
This is a first time in patient study primarily designed to evaluate the safety, tolerability, and efficacy of YH25448 in in patients with EGFR mutation positive (EGFRm+) advanced NSCLC with or without asymptomatic brain metastasis who progressed following prior therapy with an EGFR TKIs agent. This study is composed of 3 parts; part A is a dose escalation phase, part B is a dose expansion phase and part C is a dose extension phase.
In dose escalation phase, YH25448 will be escalated to reach either a maximum tolerated or absorbable dose in patients as defined by dose-limiting toxicity in NSCLC patients who progressed following prior EGFR TKIs treatment to evaluate the safety and tolerability. In dose expansion phase, further safety, tolerability, pharmacokinetic(PK) and efficacy will be evaluated at each dose level(s) of dose escalation phase in NSCLC patients who progressed following prior EGFR TKIs treatment and harbouring confirmed T790M mutation. In dose extension phase, additional 2 cohorts (2nd line therapy cohort, 1st line therapy cohort) will be enrolled to further assess the efficacy, safety, tolerability, and PK of YH25448 at the maximum tolerated dose (MTD) or recommended dose (RD) defined through dose escalation phase and dose expansion phase. Results of these studies will serve as the evidence for further clinical development.
This study will also characterize the metabolite(s) profile of YH25448 and determine PK of its metabolite(s) in biological samples if necessary. Also, exploratory correlation between biomarker profiles and pharmacokinetics/pharmacodynamics will be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| YH25448 | Experimental | Drug: YH25448* Dose Escalation Phase: Consists of 7 Cohorts * Dose Expansion Phase: Consists of 5 Cohorts * Dose Extension Phase: Consists of 2 Cohorts |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically or cytologically confirmed diagnosis of NSCLC with single activating EGFR mutations.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 3 months.
- At least one measurable extracranial lesion, not previously irradiated and not chosen biopsy during the study screening period.
- Prior to enrolling in the study, patients must have central confirmation of T790M+ mutation status from a sample taken after documented progression on the EGFR-TKIs therapy according to cohort.
Key exclusion criteria (10 listed)
- Spinal cord compression.
- Brain metastases with symptomatic and/or requiring steroid for at least 2 weeks prior to start of study treatment.
- Known intracranial hemorrhage which is unrelated to tumor.
- Central Nervous System (CNS) complications that require urgent neurosurgical intervention (e.g. resection or shunt placement).
- Leptomeningeal metastasis prior to study treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YH25448* Dose Escalation: YH25448 20mg~320mg, PO * Dose Expansion: YH25448 40mg~240mg, PO * Dose Extension: Recommended Dose 240mg of YH25448 | Drug | YH25448 |
Primary outcome
Safety and tolerability by Common Terminology Criteria for Adverse Events (CTCAE) v4.03
Time frame: Safety and tolerability profile will be collected from baseline until 28 days after the last dose, expected average 1 year.
To assess the safety and tolerability profile of YH25448 by Common Terminology Criteria for Adverse Events (CTCAE) v4.03; vital signs (blood pressure, pulse, weight); laboratory parameters (clinical chemistry, hematology, urinalysis); physical examination; centrally reviewed electrocardiograms (ECGs), echocardiogram or multiple gated acquisition scan and performance status.
Objective Response Rate (ORR)
Time frame: At baseline and every 6 weeks from first dose objective disease progression or withdrawal from study, up to approximately 1 year.
Per Response Evaluation Criteria in Solid Tumours (RECIST version 1.1) assessed by MRI or CT. ORR is the percentage of patients with at least 1 visit response of Complete Response (CR) or Partial Response (PR) (according to independent review), prior to progression or further anti-cancer therapy.
8 secondary outcomes
Duration of Response (DoR)
Time frame: At baseline and every 6 weeks from first dose objective disease progression or withdrawal from study, up to approximately 1 year.
Disease Control Rate (DCR)
Time frame: At baseline and every 6 weeks from first dose objective disease progression or withdrawal from study, up to approximately 1 year.
Progression-Free Survival (PFS)
Time frame: At baseline and every 6 weeks from first dose objective disease progression or withdrawal from study, up to approximately 1 year.
Overall Survival (OS)
Time frame: At baseline and every 6 weeks from first dose objective disease progression or withdrawal from study, up to approximately 1 year.
Tumor shrinkage
Time frame: At baseline and every 6 weeks from first dose objective disease progression or withdrawal from study, up to approximately 1 year.
Objective Intracranial Response Rate (OIRR)
Time frame: At baseline and every 6 weeks from first dose objective disease progression or withdrawal from study, up to approximately 1 year.
Duration of Intracranial Response (DoIR)
Time frame: At baseline and every 6 weeks from first dose objective disease progression or withdrawal from study, up to approximately 1 year.
Intracranial Progression Free Survival (IPFS).
Time frame: At baseline and every 6 weeks from first dose objective disease progression or withdrawal from study, up to approximately 1 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Derived from this study: PubMed 39379931Han JY, Ahn MJ, Lee KH, Lee YG, Kim DW, Min YJ, Kim SW, Cho EK, Kim JH, Lee GW, Lee SS, Lee NM, Jang HW, Han H, Park H, Lee J, Cho BC. Updated overall survival and ctDNA analysis in patients with EGFR T790M-positive advanced non-small cell lung cancer treated with lazertinib in the phase 1/2 LASER201 study. BMC Med. 2024 Oct 8;22(1):428. doi: 10.1186/s12916-024-03620-8.
- Derived from this study: PubMed 35962934Kim B, Lee J, Jang H, Lee N, Mehta J, Jang SB. Effects of Acid-Reducing Agents on the Pharmacokinetics of Lazertinib in Patients with EGFR Mutation-Positive Advanced Non-Small-Cell Lung Cancer. Adv Ther. 2022 Oct;39(10):4757-4771. doi: 10.1007/s12325-022-02286-z. Epub 2022 Aug 13.
- Derived from this study: PubMed 34958928Cho BC, Han JY, Kim SW, Lee KH, Cho EK, Lee YG, Kim DW, Kim JH, Lee GW, Lee JS, Shim BY, Kim JS, Chun SH, Lee SS, Kim HR, Hong MH, Ahn JS, Sun JM, Lee Y, Lee DH, Kang JA, Lee N, Kwon MJ, Espenschied C, Yablonovitch A, Ahn MJ. A Phase 1/2 Study of Lazertinib 240 mg in Patients With Advanced EGFR T790M-Positive NSCLC After Previous EGFR Tyrosine Kinase Inhibitors. J Thorac Oncol. 2022 Apr;17(4):558-567. doi: 10.1016/j.jtho.2021.11.025. Epub 2021 Dec 24.
- Derived from this study: PubMed 31587882Ahn MJ, Han JY, Lee KH, Kim SW, Kim DW, Lee YG, Cho EK, Kim JH, Lee GW, Lee JS, Min YJ, Kim JS, Lee SS, Kim HR, Hong MH, Ahn JS, Sun JM, Kim HT, Lee DH, Kim S, Cho BC. Lazertinib in patients with EGFR mutation-positive advanced non-small-cell lung cancer: results from the dose escalation and dose expansion parts of a first-in-human, open-label, multicentre, phase 1-2 study. Lancet Oncol. 2019 Dec;20(12):1681-1690. doi: 10.1016/S1470-2045(19)30504-2. Epub 2019 Oct 3.
- Derived from this study: PubMed 30670498Yun J, Hong MH, Kim SY, Park CW, Kim S, Yun MR, Kang HN, Pyo KH, Lee SS, Koh JS, Song HJ, Kim DK, Lee YS, Oh SW, Choi S, Kim HR, Cho BC. YH25448, an Irreversible EGFR-TKI with Potent Intracranial Activity in EGFR Mutant Non-Small Cell Lung Cancer. Clin Cancer Res. 2019 Apr 15;25(8):2575-2587. doi: 10.1158/1078-0432.CCR-18-2906. Epub 2019 Jan 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuhan Corporation study director
Clinical Development Department
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing YH25448 in people with EGFR Gene Mutation, run by Yuhan Corporation at 16 sites in South Korea.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability by Common Terminology Criteria for Adverse Events (CTCAE) v4.03 (time frame: Safety and tolerability profile will be collected from baseline until 28 days after the last dose, expected average 1 year.). The study lists 2 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 NCT03046992, which also lists 5 linked publications.
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 21 Mar 2025.