Metastatic CancerPhase 2NCT06083662
Neratinib and Trastuzumab Biosimilar in Patients with HER2 Mutated Advanced Solid Cancers
A Phase 2 study testing Neratinib Maleate in people with Metastatic Cancer and HER2 Gene Mutation, run by Korea University Guro Hospital at 1 site in South Korea.
Trial summary
Prospective, Basket, Open-label, Multi-dose, Single-arm, Simon's two-stage, Multi-center trial Study drug : neratinib + herzuma (trastuzumab biosimilar) Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Metastatic Cancer, HER2 Gene Mutation
- What is being tested?
- Neratinib Maleate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Jun 2021to 30 Dec 2024
- Phase
- Phase 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who voluntarily decide to participate and give written consent after hearing the explanation of the clinical trial and investigational drugs.
- Adult men and women over 19 years old.
- Histological or cytological confirmed advanced solid tumor and confirmed to have HER2 known oncogenic mutations in tumor DNA by K-master panel test using tumor tissues or circulating tumor DNA in blood.
- Patients having at least 1 or more than 1 measurable lesion according to RECIST v 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status 0~2.
- Patients whose life expectancy is more than 6 months.
- Metastatic/progressive solid cancer patients who have received one or more than one standard treatment or do not have any treatment option.
- Patients who have agreed to provide plasma/blood samples, the most recent metastatic/progressive tumor sample or new tumor biopsy for gene sequencing and other biomarker analysis.
Who cannot join
- Patients who received radiotherapy or surgical treatment within 2 weeks prior to the initiation of investigational product.
- Patients having symptomatic brain metastasis who needs treatment. Patients with stable brain metastasis who need no treatment including steroid are eligible
- Inappropriate HER2 mutation (e.g., non-Hot Spot mutation, variant of unknown siginificance, subclonal mutation, premature STOP codon or the Frame Shift mutation).
- Patients having difficulties in swallowing tablets.
- Patients with toxicities of prior treatment which are not recovered to baseline level or ≤ Grade 1.
- Inadequate organ functions:
Show all 13Show fewer
- Hemoglobin (Hemoglobin) < 8 .0g / dL
- Absolute neutrophil count (ANC) < 1. 0 x10 ³ per mm³
- Platelet count < 100 x10⁹/L (100 ,000/ mm³)
- Total bilirubin > 1.5 x upper normal limits (UNL), (exclude Gilbert's syndrome)
- Alanine aminotransferase (ALT) or aspartate amino transferase (AST) > 3 x upper normal limits (UNL) (in case of liver and bone metastases > 5 x ULN)
- Serum creatinine >1.5 x upper normal limits (UNL) or < eGFR 30 mL/min/1.73 m² 7) Left ventricle ejection fraction <50% by multi-gate obtaining method scan (MUGA) or echocardiogram.
- 8) Chronic gastrointestinal disorders of which a main symptom is diarrhea (e.g., Crohn's disease, malabsorption, or grade 2 or more than grade 2 diarrhea according to the NCI CTCAE version 5.0 regardless of etiology).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Basket Trial to Evaluate Safety and Efficacy of Neratinib, an Irreversible Tyrosine Kinases Inhibitor of EGFR, ERBB2 and ERBB4 Receptors and Trastuzumab Biosimilar (Herzuma®) in Patients with HER2 Mutated Advanced Solid Cancers
Prospective, Basket, Open-label, Multi-dose, Single-arm, Simon's two-stage, Multi-center trial
Study drug : neratinib + herzuma (trastuzumab biosimilar)
Read the detailed description
- Primary objective Evaluate overall response rate (ORR) in HER2 mutated advanced solid cancer patients based on RECIST v1.1
- Secondary objectives (1) Evaluate clinical benefit rate (CBR) (2) Evaluate duration of response (DOR) (3) Evaluate progression free survival (PFS) (4) Evaluate overall survival (OS) (5) Evaluate compliance with oral administration 3) Safety evaluation
- Evaluate the overall safety of the test drug
- Evaluate the predefined adverse event (diarrhea)
- Conditions
- Metastatic Cancer, HER2 Gene Mutation
- Being tested
- Neratinib Maleate
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neratinib MaleateDrug
Also called Herzuma
- neratinib 240mg po daily
- herzuma 8mg/kg (loading) --> 6mg/kg q3w
| Study group | Role | What they receive |
|---|---|---|
| A arm | Experimental | Neratinib + herzuma Receives: Drug: Neratinib Maleate |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate (ORR)
ORR according to RECIST v1.1
Measured: at 6 months
Secondary outcomes (4)
clinical benefit rate, CBR
CR+PR + SD more than 12 weeks
Measured: at 6 months
median duration of response, DOR
DOR is related to the quality of life and is one of the methods for evaluating tumor response approved by pharmaceutical regulatory agencies
Measured: at 6 months
median progression free survival, PFS
from enrollment to disease progression, death or withdrawal
Measured: at 6 months
safety profiles
safety profiles according to CTCAE 4.0
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start15 Jun 2021
- Primary completion30 Nov 2023
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korean Cancer Study Group
- Responsible party
- Principal investigator, Park, In Hae, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083662
- Sponsor's protocol ID
- AL20-17
- Status last verified
- Mar 2024
- First submitted
- 9 Oct 2023
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Basket Trial to Evaluate Safety and Efficacy of Neratinib, an Irreversible Tyrosine Kinases Inhibitor of EGFR, ERBB2 and ERBB4 Receptors and Trastuzumab Biosimilar (Herzuma®) in Patients with HER2 Mutated Advanced Solid Cancers
- ClinicalTrials.gov ID
- NCT06083662
- Acronym / sponsor ID
- AL20-17
- Conditions
- Metastatic Cancer, HER2 Gene Mutation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Collaborators
- Korean Cancer Study Group
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 16 Oct 2023 (actual)
- 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.
Prospective, Basket, Open-label, Multi-dose, Single-arm, Simon's two-stage, Multi-center trial
Study drug : neratinib + herzuma (trastuzumab biosimilar)
Detailed description
- Primary objective Evaluate overall response rate (ORR) in HER2 mutated advanced solid cancer patients based on RECIST v1.1
- Secondary objectives (1) Evaluate clinical benefit rate (CBR) (2) Evaluate duration of response (DOR) (3) Evaluate progression free survival (PFS) (4) Evaluate overall survival (OS) (5) Evaluate compliance with oral administration 3) Safety evaluation
- Evaluate the overall safety of the test drug
- Evaluate the predefined adverse event (diarrhea)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A arm | Experimental | Drug: Neratinib MaleateNeratinib + herzuma |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients who voluntarily decide to participate and give written consent after hearing the explanation of the clinical trial and investigational drugs.
- Adult men and women over 19 years old.
- Histological or cytological confirmed advanced solid tumor and confirmed to have HER2 known oncogenic mutations in tumor DNA by K-master panel test using tumor tissues or circulating tumor DNA in blood.
- Patients having at least 1 or more than 1 measurable lesion according to RECIST v 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status 0~2.
Key exclusion criteria (13 listed)
- Patients who received radiotherapy or surgical treatment within 2 weeks prior to the initiation of investigational product.
- Patients having symptomatic brain metastasis who needs treatment. Patients with stable brain metastasis who need no treatment including steroid are eligible
- Inappropriate HER2 mutation (e.g., non-Hot Spot mutation, variant of unknown siginificance, subclonal mutation, premature STOP codon or the Frame Shift mutation).
- Patients having difficulties in swallowing tablets.
- Patients with toxicities of prior treatment which are not recovered to baseline level or ≤ Grade 1.
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 |
|---|---|---|
| Neratinib MaleateAlso: Herzuma* neratinib 240mg po daily * herzuma 8mg/kg (loading) --> 6mg/kg q3w | Drug | A arm |
Primary outcome
overall response rate (ORR)
Time frame: at 6 months
ORR according to RECIST v1.1
4 secondary outcomes
clinical benefit rate, CBR
Time frame: at 6 months
median duration of response, DOR
Time frame: at 6 months
median progression free survival, PFS
Time frame: at 6 months
safety profiles
Time frame: at 6 months
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 18 Mar 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neratinib Maleate in people with Metastatic Cancer and HER2 Gene Mutation, run by Korea University Guro Hospital at 1 site 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 8 inclusion and 13 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 18 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 1 site 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 phase mean?
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?
overall response rate (ORR) (time frame: at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2025.