Health TrialsbyHealthPanel

Neratinib Tablets Monotherapy for Advanced Solid Tumors With HER2 Mutations

ConditionAdvanced Solid Tumor
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorConvalife (Shanghai) Co., Ltd.

About this trial

Evaluating the efficacy of Neratinib tablets monotherapy in treating advanced solid tumors with HER2 mutations.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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);

Trial design

Design model

Single group

Treatments tested in this trial

  • Neratinib tablets

    Drug

    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).

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: (Trial group)-Neratinib tabletsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Throughout the study for approximately 3.5 years

Secondary outcomes

1

Duration of Response (DoR)

DoR as assessed by the investigator

Time frame
Throughout the study for approximately 3.5 years
2

Progression-Free Survival (PFS)

PFS as assessed by the investigator

Time frame
Throughout the study for approximately 3.5 years
3

Disease Control Rate (DCR)

DCR as assessed by the investigator

Time frame
Throughout the study for approximately 3.5 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Convalife (Shanghai) Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: