Nimotuzumab treatment for advanced solid tumors with EGFR amplification

An Open ,Single Arm, Prospective and Basket Clinical Study of Nimotuzumab in the Treatment of EGFR-amplified Advanced Pan Solid Tumors (Lung/Esophageal/Gastric/Pancreatic /Colorectal / Head and Neck Cervical)

This study is testing if nimotuzumab can help people with advanced solid tumors that have EGFR amplification, like lung or pancreatic cancer, by looking at their genetic makeup to find the best treatment options.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 46 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Tianjin Medical University Second Hospital (Academic / other)
• Drugs / interventions: prednisone, nimotuzumab, Nitozumab
• Locations: 1 site (Tianjin, Tianjin)
• Trial ID: NCT06022276 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of nimotuzumab, an EGFR monoclonal antibody, in patients with EGFR-amplified advanced pan solid tumors, including lung, esophageal, gastric, pancreatic, colorectal, and head and neck cancers. The study utilizes tissue-next-generation sequencing, liquid-NGS, or fluorescence in situ hybridization to determine EGFR amplification status, which is assessed by CLIA-certified laboratories. Patients' molecular testing results are analyzed to propose appropriate combination therapy strategies based on their treatment history and condition. The trial also aims to explore molecular markers that may predict the efficacy of nimotuzumab.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-80 with advanced solid tumors and known EGFR amplification who have exhausted standard treatment options.

Not a fit: Patients without EGFR amplification or those who are not eligible for the specified cancer types may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that have EGFR amplification.

How similar studies have performed: Other studies have shown promising results with EGFR-targeted therapies, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. Esophageal cancer, gastric cancer, pancreatic cancer, colorectal cancer (left colorectal cancer), head and neck cancer (including oral cancer, oropharyngeal cancer, hypopharyngeal cancer, laryngeal cancer, nasopharyngeal cancer, oropharyngeal cancer must be p16 negative: p16 ≥ 70% is positive), cervical cancer, local recurrence or with distant metastasis. Patients with known EGFR amplification and standard treatment depletion or inability to tolerate standard treatment and disease progression. Allow patients with stable symptoms of brain metastasis to be enrolled.
2. Age 18-80 years old, both male and female. Expected life\>3 months.
3. According to the criteria for evaluating the efficacy of solid tumors (RECIST 1.1), there should be at least one measurable lesion that has not undergone local treatment such as radiotherapy (lesions located within the previous radiotherapy area, if confirmed to have progressed and meet the RECIST 1.1 criteria, can also be selected as target lesions).
4. It has been confirmed through NGS testing that EGFR amplification exists simultaneously (all cancer species).
5. ECOG: 0-2.
6. Expected survival time ≥ 12 weeks.
7. If the main organs function normally, they meet the following standards:

(1) Blood routine examination: a. HB ≥ 90g/L;b. ANC ≥ 1.5 × 10\^9/L;c. PLT ≥ 80 × 10\^9/L.

(2) Biochemical examination: a. ALB ≥ 30g/L;b. ALT and AST ≤ 2.5ULN. If there is liver metastasis, ALT and AST ≤ 5ULN; c. TBIL ≤ 1.5ULN; d. Plasma Cr ≤ 1.5ULN or creatinine clearance rate (CCr) ≥ 60ml/min.

8. Women of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives, or condoms) during the study period and within 6 months after the end of the study. Within 7 days prior to enrollment in the study, the serum or urine pregnancy test was negative and must be a non-lactating patient. Men should agree to patients who must use contraception during the study period and within 6 months after the end of the study period.

9. The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.

Exclusion criteria:

1. The patient has any active autoimmune disease or autoimmune disease (For example, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism. patients with vitiligo. asthma that has completely relieved in childhood and does not require any intervention in adulthood can be included. asthma that requires medical intervention with bronchodilators cannot be included).
2. The patient is currently using systemic hormone therapy to achieve immunosuppressive effects (dosage\>10mg/day of prednisone or other therapeutic hormones) and continues to use it within 2 weeks before enrollment.
3. Previously received treatment with EGFR monoclonal antibodies or EGFR tyrosine kinase inhibitors.
4. Patients with any severe and/or uncontrollable diseases, including:

   Patients with poor blood pressure control (systolic blood pressure ≥ 150mm Hg or diastolic blood pressure ≥ 100 mmHg). Suffering from grade I or above myocardial ischemia or infarction, arrhythmia (including QT interval ≥ 480ms), and grade I cardiac dysfunction. Active or uncontrollable serious infections. Liver diseases such as decompensated liver disease, active hepatitis B (HBV-DNA ≥ 10\^4 copies/ml or 2000IU/ml) or hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the detection limit of the analytical method).
5. Patients whose imaging shows that the tumor has invaded important blood vessels or who have been determined by the researchers to be highly likely to invade important blood vessels and cause fatal massive bleeding during subsequent studies.
6. Pregnant or lactating women.
7. Patients with other malignant tumors within 5 years (excluding cured skin basal cell carcinoma and cervical carcinoma in situ).
8. Patients who have a history of abuse of psychotropic substances and are unable to quit or have mental disorders.
9. Patients who have participated in clinical trials of other drugs within four weeks.
10. Researchers believe that it is not suitable for inclusion.

Where this trial is running

Tianjin, Tianjin

• Tianjin Medical University Second Hospital — Tianjin, Tianjin, China (Recruiting)

Study contacts

• Principal investigator: HaiTao Wang, Ph.D — Tianjin Medical University Second Hospital
• Study coordinator: HaiTao Wang, Ph.D

Conditions Solid Tumor; EGFR Amplification; Nimotuzumab; EGFR