Nimotuzumab in EGFR Highly Expressed Pancreatic Neuroendocrine Neoplasms

Preliminary Exploration of Therapeutic Efficacy of Nimotuzumab in EGFR Highly Expressed Pancreatic Neuroendocrine Neoplasms

The phase II study is performed to assess the efficacy and safety of Nimotuzumab in patients with stage IV pancreatic neuroendocrine neoplasms and EGFR overexpression.

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Neuroendocrine Neoplasm
• Intervention / Treatment: Drug: Nimotuzumab

Detailed Description

Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with various types of cancer with EGFR overexpression. The phase II study is performed to assess the efficacy and safety of Nimotuzumab in patients with stage IV pancreatic neuroendocrine neoplasms and EGFR overexpression.

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Histologically or cytologically proven diagnosis of pancreatic neuroendocrine tumors (pNET) with well and moderately differentiated with evidence of unresectable disease or metastatic disease. Locally advanced disease must not be amendable to resection or radiation therapy with curative intent.
2. Overexpression of EGFR in tumor tissue sample from tumor biopsy or prior primary tumor resection. Therefore availability of paraffin-embedding tumor tissue sample is needed.
3. Documented progression of the disease by CT scan, MRI, or Octreoscan within 12 months prior to baseline.
4. Measurable disease as per RECIST. Measurable lesions that have been previously radiated will not be considered target lesions unless increase in size has been observed following completion of radiation therapy.
5. Male or female, 18 years of age or older.
6. ECOG performance status less than 2.
7. Life expectancy greater than 12 weeks.

8. The definitions of minimum adequacy for organ function required prior to study entry are as follows.

   Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) < 2.5 x upper limit of normal (ULN), or AST and ALT < 5 x ULN if liver function abnormalities are due to underlying malignancy Total serum bilirubin < 1.5 x ULN Serum albumin > 3.0 g/dL Absolute neutrophil count (ANC) > 1500/L Hemoglobin > 9.0 g/dL Creatinin clearance < 40 mL/min

9. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.
10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion Criteria:

1. Active second primary malignancy or history of second primary malignancy.
2. Current treatment on another clinical trial.
3. Any of the following within the 12 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolus.
4. Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to randomization.
5. Pathological confirmed to be poor differentiated tumor of pancreatic neuroendocrine neoplasms.
6. Patients who are unwilling or unable to comply with study procedures.
7. Prior targeted treatment on EGFR.
8. Low expression or absence of EGFR in tumor tissue sample from tumor biopsy or prior primary tumor resection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nimotuzumab; nimotuzumab 200mg/week	Drug: Nimotuzumab; nimotuzumab 200mg/week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response rate (ORR)	Overall Response rate was defined as the proportion of patients with a best overall response of complete response or partial response, based on investigator's assessment as per RECIST criteria version 1.1.	Baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease control rate (DCR)	Disease control rate was defined as the proportion of patients with a best overall response of Complete Response, Partial response, or Stable disease, based on the investigator's assessment per RECIST version 1.1.	Baseline to 6 months
Progression free survival (PFS)		Patients will be followed until disease progression, estimating around 12months
Overall survival (OS)		Patients will be followed until disease progression, estimating around 12months

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): April 30, 2025
• Study Completion (Anticipated): December 30, 2026

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: April 4, 2022
• First Posted (Actual): April 7, 2022

Study Record Updates

• Last Update Posted (Actual): April 7, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: EGFR; nimotuzumab; Pancreatic Neuroendocrine Neoplasm
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Pancreatic Diseases; Adenoma; Pancreatic Neoplasms; Neoplasms; Neuroendocrine Tumors; Adenoma, Islet Cell; Antineoplastic Agents; Antineoplastic Agents, Immunological; Nimotuzumab
• Other Study ID Numbers: PTCA199-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No