Nimotuzumab in EGFR Highly Expressed Pancreatic Neuroendocrine Neoplasms

Phase 2

Not yet recruiting

• Conditions: Pancreatic Neuroendocrine Neoplasm
• Interventions: Drug: Nimotuzumab

• Registration Number: NCT05316480
• Lead Sponsor: Fudan University

Brief Summary

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.

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 Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-28
• Study First Submitted QC: 2022-04-04
• Last Update Submitted: 2022-04-04
• Study First Posted: 2022-04-07
• Last Update Posted: 2022-04-07
• Study Start: 2022-05-01
• Primary Completion: 2025-04-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nimotuzumab	Nimotuzumab	nimotuzumab 200mg/week

Primary Outcome Measures

Name	Time	Method
Overall response rate (ORR)	Baseline to 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Disease control rate (DCR)	Baseline to 6 months	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.
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

Trial Locations

Locations (1)

Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University; 🇨🇳 Shanghai, Shanghai, China