Advanced Solid TumorPhase 2CVL009-C2001NCT06519110
Neratinib Tablets Monotherapy for Advanced Solid Tumors With HER2 Mutations
A Phase 2 study testing Neratinib tablets in people with Advanced Solid Tumor, run by Convalife (Shanghai) Co., Ltd..
Trial summary
Evaluating the efficacy of Neratinib tablets monotherapy in treating advanced solid tumors with HER2 mutations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- Neratinib tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 10 Aug 2024to 15 Apr 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Age is 18 years or older, and the patient can be male or female;
- 2.Histologically or cytologically confirmed advanced non-small cell lung cancer, cholangiocarcinoma, cervical cancer, and salivary gland cancer patients; those who have failed to respond to ≤2 lines of standard treatment (disease progression after treatment or intolerable toxic side effects of treatment), or have no standard treatment options, or are unable to receive standard treatment;
- 3.Previously underwent second-generation sequencing testing with evidence of HER2 mutation, otherwise, the patient must provide sufficient tissue samples for second-generation sequencing testing in the study's central laboratory, with tissue samples being the primary source; if tissue slices or samples that meet the requirements cannot be obtained, blood samples may be provided for testing.
- 4.According to the RECIST v1.1 criteria (see Appendix 1), there must be at least one measurable lesion; if the only lesion is one that has previously received local treatment (such as radiotherapy, ablation, interventional treatment, etc.), there must be clear radiological evidence of disease progression;
- 5.Eastern Cooperative Oncology Group (ECOG) performance status score is 0-1;
- 6.Predicted survival is 3 months or more;
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- 7.Bone marrow reserve must meet the following laboratory value criteria: Absolute neutrophil count (ANC) is ≥1.5 × 10^9/L; Platelet count (PLT) is ≥90 × 10^9/L; Hemoglobin (Hb) is ≥90 g/L; Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) are ≤2.5 × ULN (the upper limit of the normal range); if liver metastasis is present, it should be ≤5 × ULN; Total bilirubin (TBIL) is ≤1.5 × ULN; Blood urea/urea nitrogen (UREA/BUN) and Creatinine (Cr) are ≤1.5 × ULN; Coagulation function: International normalized ratio (INR) and Activated partial thromboplastin time (APTT) are ≤1.5 × ULN; Urine protein is less than 2+ (if baseline urine protein is ≥2+, a 24-hour urine protein quantification should be performed, and it is acceptable for inclusion if ≤1g);
- 8.Women of reproductive age should agree to use contraceptive measures (such as intrauterine devices, hormonal contraceptives, or condoms) during the study period and for 6 months after the study ends; they must have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must not be breastfeeding; men should agree to use contraceptive measures during the study period and for 6 months after the study ends;
- 9.The subject can understand the nature of this study, and the subject and/or legal representative voluntarily agrees to participate in this trial and signs the informed consent.
Who cannot join
- 1.Patients who have previously received treatment with any HER2-targeted tyrosine kinase inhibitors (such as lapatinib, pyrotinib, neratinib, etc.);
- 2.Those who do not meet the following requirements for the washout period from previous anti-tumor treatments before the first administration of the study drug: the washout time from the end of the last dose of previous anti-tumor treatment to the first administration of the study drug (calculated from the end of the last dose) is as follows: chemotherapy ≥3 weeks (oral fluorouracil ≥2 weeks; mitomycin C, nitrosoureas ≥6 weeks), small molecule targeted therapy ≥2 weeks, large molecule drugs (including immunotherapy) ≥4 weeks, radiotherapy ≥4 weeks (local palliative radiotherapy ≥2 weeks), Chinese medicine with anti-tumor indications ≥2 weeks, other anti-tumor treatments ≥4 weeks, investigational drugs or treatments that are not yet marketed ≥4 weeks;
- 3.Received major organ surgery (excluding biopsy) or had significant trauma within 4 weeks before the first administration of the study drug;
- 4.Spinal cord compression or brain metastasis, unless asymptomatic, stable, and has not required steroid treatment for at least 4 weeks before the start of the study treatment (before dosing);
- 5.A history of other malignant tumors within the past 5 years, excluding cured cancers such as cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin;
- 6.Adverse reactions from previous anti-tumor treatments have not recovered to a grade of ≤1 according to CTCAE 5.0 (except for toxicities judged by the investigator to have no safety risk, such as alopecia, grade 2 peripheral neurotoxicity, thyroid hypothyroidism stable with hormone replacement therapy);
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- 7.The presence of uncontrollable third-space fluid accumulation (such as a large amount of pleural effusion, ascites, or pericardial effusion) that cannot be managed by drainage or other methods;
- 8.Patients with gastrointestinal diseases that may affect drug absorption (such as Crohn's disease, intestinal obstruction, active peptic ulcer disease, etc.);
- 9.Patients currently suffering from interstitial lung disease;
- 10.Patients with any cardiac disease, including: (1) unstable angina; (2) clinically significant arrhythmias requiring medication; (3) myocardial infarction; (4) heart failure of grade 3 or higher; (5) echocardiography: left ventricular ejection fraction (LVEF) ≤50%; (6) 12-lead electrocardiogram: QTcF: females >470 milliseconds, males >450 milliseconds; (7) any other cardiac disease judged by the investigator to be unsuitable for participating in this trial;
- 11.History of immunodeficiency, including HIV antibody test positive;
- 12.Active hepatitis B or C (HBV DNA, HCV RNA test results at screening are not within the normal range of the central laboratory);
- 13.According to the investigator's judgment, there are other serious accompanying diseases that endanger patient safety or affect the patient's ability to complete the study (such as uncontrolled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg after taking antihypertensive drugs), diabetes (glycated hemoglobin >9.0%), autoimmune diseases, etc.);
- 14.The investigator deems the subject unsuitable for other reasons to participate in this study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Single-arm, Open-label, Multicenter Phase II Clinical Study of Neratinib Tablets Monotherapy in the Treatment of Advanced Solid Tumors With HER2 Mutations
Evaluating the efficacy of Neratinib tablets monotherapy in treating advanced solid tumors with HER2 mutations.
Read the detailed description
This single-arm, open-label, multicenter Phase II clinical study is divided into three phases: screening, treatment, and follow-up. The screening phase occurs within 28 days prior to the first administration of the study drug. During the treatment phase, a 28-day cycle is used, and tumor efficacy is assessed according to the RECIST 1.1 criteria. Assessments are conducted at the end of the first cycle (±3 days), followed by imaging evaluations every 8 weeks until disease progression. During the treatment period, the investigator may increase the number of assessments based on clinical needs. The study drug will be administered continuously until intolerable adverse reactions occur, disease progression, withdrawal of informed consent, loss to follow-up, death, or study termination.
The follow-up phase includes safety and survival follow-up. Safety follow-up occurs within 28 days after the last administration of the study drug. Survival follow-up is conducted every 12 weeks to collect the survival status of the subjects until their death, loss to follow-up, withdrawal from the study, or study termination (whichever occurs first).
- Conditions
- Advanced Solid Tumor
- Being tested
- Neratinib tablets
- Keywords
- HER2 mutation-positive, Non-Small Cell Lung Cancer (NSCLC), Cholangiocarcinoma, Cervical Cancer, Salivary Gland Cancer, Neratinib tablets
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Cholangiocarcinoma, Uterine Cervical Neoplasms, Salivary Gland Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neratinib tabletsDrug
Also called Neratinib
In the first week, take Neratinib tablets 120mg orally, in the second week take Neratinib tablets 160mg orally, and from the third week until the end of treatment, take Nilotinib tablets 240mg orally (from Cycle 1 Day 15 until the end of treatment).
| Study group | Role | What they receive |
|---|---|---|
| (Trial group)-Neratinib tablets | Experimental | The subjects enrolled in the study will take Neratinib tablets orally as follows: 120mg in the 1st week, 160mg in the 2nd week, and 240mg from the 3rd week until the end of treatment (starting from C1D15 to the end of treatment). During the Neratinib treatment period, loperamide will be administered on an as-needed basis based on the condition of diarrhea.
Neratinib tablets should be taken orally once daily, with the tablet to be swallowed whole with a meal, without crushing, breaking, or chewing. A continuous 28-day medication period constitutes one treatment cycle. Receives: Drug: Neratinib tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rates of the central nervous system as assessed by the Independent Imaging Evaluation Committee based on RECIST1.1
Objective response rates of the central nervous system as assessed by the Independent Imaging Evaluation Committee based on RECIST1.1
Measured: Throughout the study for approximately 3.5 years
Secondary outcomes (3)
Duration of Response (DoR)
DoR as assessed by the investigator
Measured: Throughout the study for approximately 3.5 years
Progression-Free Survival (PFS)
PFS as assessed by the investigator
Measured: Throughout the study for approximately 3.5 years
Disease Control Rate (DCR)
DCR as assessed by the investigator
Measured: Throughout the study for approximately 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start10 Aug 2024 (estimated)
- Primary completion14 Feb 2026 (estimated)
- Study completion15 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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
- Model description
- Patients with advanced solid tumors (non-small cell lung cancer, cholangiocarcinoma, cervical cancer, salivary gland cancer) with HER2 mutations.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Convalife (Shanghai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- jin Li, ph.D, Principal investigator, Shanghai GoBroad Cancer Hospital China Pharmaceutical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519110
- Sponsor's protocol ID
- CVL009-C2001
- Acronym
- CVL009-C2001
- Status last verified
- Jul 2024
- First submitted
- 16 Jul 2024
- Last updated
- 25 Jul 2024
- Results posted
- 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 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label, Multicenter Phase II Clinical Study of Neratinib Tablets Monotherapy in the Treatment of Advanced Solid Tumors With HER2 Mutations
- ClinicalTrials.gov ID
- NCT06519110
- Acronym / sponsor ID
- CVL009-C2001 / CVL009-C2001
- Conditions
- Advanced Solid Tumor
- Keywords
- HER2 mutation-positive, Non-Small Cell Lung Cancer (NSCLC), Cholangiocarcinoma, Cervical Cancer, Salivary Gland Cancer, Neratinib tablets
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Convalife (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Aug 2024 (estimated)
- Primary completion
- 14 Feb 2026 (estimated)
- Study completion
- 15 Apr 2026 (estimated)
- First posted
- 25 Jul 2024 (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.
Evaluating the efficacy of Neratinib tablets monotherapy in treating advanced solid tumors with HER2 mutations.
Detailed description
This single-arm, open-label, multicenter Phase II clinical study is divided into three phases: screening, treatment, and follow-up. The screening phase occurs within 28 days prior to the first administration of the study drug. During the treatment phase, a 28-day cycle is used, and tumor efficacy is assessed according to the RECIST 1.1 criteria. Assessments are conducted at the end of the first cycle (±3 days), followed by imaging evaluations every 8 weeks until disease progression. During the treatment period, the investigator may increase the number of assessments based on clinical needs. The study drug will be administered continuously until intolerable adverse reactions occur, disease progression, withdrawal of informed consent, loss to follow-up, death, or study termination.
The follow-up phase includes safety and survival follow-up. Safety follow-up occurs within 28 days after the last administration of the study drug. Survival follow-up is conducted every 12 weeks to collect the survival status of the subjects until their death, loss to follow-up, withdrawal from the study, or study termination (whichever occurs first).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with advanced solid tumors (non-small cell lung cancer, cholangiocarcinoma, cervical cancer, salivary gland cancer) with HER2 mutations.
| Arm | Type | Receives |
|---|---|---|
| (Trial group)-Neratinib tablets | Experimental | Drug: Neratinib tabletsThe subjects enrolled in the study will take Neratinib tablets orally as follows: 120mg in the 1st week, 160mg in the 2nd week, and 240mg from the 3rd week until the end of treatment (starting from C1D15 to the end of treatment). During the Neratinib treatment period, loperamide will be administered on an as-needed basis based on the condition of diarrhea. Neratinib tablets should be taken orally once daily, with the tablet to be swallowed whole with a meal, without crushing, breaking, or chewing. A continuous 28-day medication period constitutes one treatment cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1.Age is 18 years or older, and the patient can be male or female;
- 2.Histologically or cytologically confirmed advanced non-small cell lung cancer, cholangiocarcinoma, cervical cancer, and salivary gland cancer patients; those who have failed to respond to ≤2 lines of standard treatment (disease progression after treatment or intolerable toxic side effects of treatment), or have no standard treatment options, or are unable to receive standard treatment;
- 3.Previously underwent second-generation sequencing testing with evidence of HER2 mutation, otherwise, the patient must provide sufficient tissue samples for second-generation sequencing testing in the study's central laboratory, with tissue samples being the primary source; if tissue slices or samples that meet the requirements cannot be obtained, blood samples may be provided for testing.
- 4.According to the RECIST v1.1 criteria (see Appendix 1), there must be at least one measurable lesion; if the only lesion is one that has previously received local treatment (such as radiotherapy, ablation, interventional treatment, etc.), there must be clear radiological evidence of disease progression;
- 5.Eastern Cooperative Oncology Group (ECOG) performance status score is 0-1;
Key exclusion criteria (14 listed)
- 1.Patients who have previously received treatment with any HER2-targeted tyrosine kinase inhibitors (such as lapatinib, pyrotinib, neratinib, etc.);
- 2.Those who do not meet the following requirements for the washout period from previous anti-tumor treatments before the first administration of the study drug: the washout time from the end of the last dose of previous anti-tumor treatment to the first administration of the study drug (calculated from the end of the last dose) is as follows: chemotherapy ≥3 weeks (oral fluorouracil ≥2 weeks; mitomycin C, nitrosoureas ≥6 weeks), small molecule targeted therapy ≥2 weeks, large molecule drugs (including immunotherapy) ≥4 weeks, radiotherapy ≥4 weeks (local palliative radiotherapy ≥2 weeks), Chinese medicine with anti-tumor indications ≥2 weeks, other anti-tumor treatments ≥4 weeks, investigational drugs or treatments that are not yet marketed ≥4 weeks;
- 3.Received major organ surgery (excluding biopsy) or had significant trauma within 4 weeks before the first administration of the study drug;
- 4.Spinal cord compression or brain metastasis, unless asymptomatic, stable, and has not required steroid treatment for at least 4 weeks before the start of the study treatment (before dosing);
- 5.A history of other malignant tumors within the past 5 years, excluding cured cancers such as cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin;
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 tabletsAlso: NeratinibIn the first week, take Neratinib tablets 120mg orally, in the second week take Neratinib tablets 160mg orally, and from the third week until the end of treatment, take Nilotinib tablets 240mg orally (from Cycle 1 Day 15 until the end of treatment). | Drug | (Trial group)-Neratinib tablets |
Primary outcome
Objective response rates of the central nervous system as assessed by the Independent Imaging Evaluation Committee based on RECIST1.1
Time frame: Throughout the study for approximately 3.5 years
Objective response rates of the central nervous system as assessed by the Independent Imaging Evaluation Committee based on RECIST1.1
3 secondary outcomes
Duration of Response (DoR)
Time frame: Throughout the study for approximately 3.5 years
Progression-Free Survival (PFS)
Time frame: Throughout the study for approximately 3.5 years
Disease Control Rate (DCR)
Time frame: Throughout the study for approximately 3.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- 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.
jin Li, ph.D principal investigator
Shanghai GoBroad Cancer Hospital China Pharmaceutical University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neratinib tablets in people with Advanced Solid Tumor, run by Convalife (Shanghai) Co., Ltd..
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 9 inclusion and 14 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 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jin Li, ph.D (021-60571204, lijin@csco.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rates of the central nervous system as assessed by the Independent Imaging Evaluation Committee based on RECIST1.1 (time frame: Throughout the study for approximately 3.5 years). 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 25 Jul 2024.