Clinical trial · Interventional
Monoclonal Antibody ABX-EGF in Treating Patients With Renal (Kidney), Prostate, Pancreatic, Non-Small Cell Lung, Colon or Rectal, Esophageal, or Gastroesophageal Junction Cancer
An Open Label, Multiple Dose, Dose-Rising Clinical Trial of the Safety of ABX-EGF in Patients With Renal, Prostate, Pancreatic, Non-Small-Cell Lung, Colorectal, or Esophageal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Monoclonal antibodies such as ABX-EGF can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody ABX-EGF in treating patients who have either renal (kidney), prostate, pancreatic, non-small cell lung, colon, rectal, esophageal, or gastroesophageal junction cancer.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| panitumumab | Biological | Panitumumab | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed diagnosis of 1 of the following:
* Renal cell cancer (RCC)
* Prior nephrectomy required
* Prostate cancer
* Failed prior primary therapy (e.g., surgery, radiotherapy, or chemotherapy)
* Failed prior hormonal therapy (e.g., antiandrogen, luteinizing hormone-releasing hormone inhibitor, or orchiectomy)
* Pancreatic cancer
* Failed at least 1 prior standard therapy regimen for unresectable metastatic disease
* Non-small cell lung cancer
* Failed at least 1 prior standard therapy regimen for unresectable metastatic disease
* Colorectal cancer
* Received 1 or more prior chemotherapy regimen(s) for advanced metastatic disease
* Esophageal cancer
* Failed prior primary therapy (e.g., surgery, radiotherapy, or chemotherapy)
* Gastroesophageal junction cancer
* Evaluable disease
* Epidermal growth factor receptor overexpression
* Tumor tissue must yield the sum of 1+, 2+, or 3+ staining in at least 10% of evaluated tumor cells
* No uncontrolled brain metastases
* No evidence of disease progression or regression after a 30-day washout period
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 70-100% OR
* ECOG 0-1
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count greater than 1,000/mm\^3
* Platelet count greater than 100,000/mm\^3
Hepatic:
* AST/ALT no greater than 2 times upper limit of normal (ULN) (3 times ULN for liver metastases)
* Alkaline phosphatase no greater than 2 times ULN (3 times ULN for liver metastases)
Renal:
* Creatinine less than 2.2 mg/dL
* NCI renal toxicity no greater than grade 2
* No hypercalcemia (antihypercalcemic therapy allowed)
Cardiovascular:
* Ejection fraction at least 45% by MUGA
* No abnormal ECG or MUGA
* No myocardial infarction within the past year
Pulmonary:
* No abnormal chest x-ray
* FEV\_1 greater than 50% of predicted
Other:
* No known allergy to ingredients of study drug
* No known allergy to Staphylococcus aureus Protein A
* HIV negative
* No chronic medical or psychiatric condition that would preclude study compliance
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 2 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 30 days since prior biologic therapy (e.g., antibodies, cytokines, or co-stimulatory pathway inhibitors)
* No other concurrent biologic therapy
Chemotherapy:
* See Disease Characteristics
* At least 6 weeks since prior chemotherapy and recovered
* No prior chemotherapy for RCC
* No prior anthracyclines
* No concurrent chemotherapy
Endocrine therapy:
* See Disease Characteristics
* Concurrent steroids allowed
* Concurrent hormonal therapy allowed
Radiotherapy:
* See Disease Characteristics
* No prior mediastinal radiotherapy
* No concurrent radiotherapy
Surgery:
* See Disease Characteristics
* Recovered from any recent prior surgery
Other:
* At least 30 days since prior investigational drug or device
* At least 30 days since prior systemic therapy
* No other concurrent investigational drugs
* No other concurrent systemic agents or cancer therapyReferences
Publications (0)
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