Clinical trial · Interventional
Bispecific Antibody in Finding Tumor Cells in Patients With Colorectal Cancer
Phase I Study of Preoperative Detection of Colorectal Carcinoma With Bispecific Antibody Pretargeting
NCT00895323CI-TRIAL-00012138unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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: Diagnostic procedures, such as radionuclide imaging using bispecific antibody, may help find colorectal cancer cells and learn the extent of disease. PURPOSE: This phase I trial is studying how well a bispecific antibody works in finding tumor cells in patients with colorectal cancer.
Conditions
Conditions (1)
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 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| enzyme-linked immunosorbent assay | Other | — | UNRESOLVED |
| iodine I 131-labeled anti-CEA/anti-HSG bispecific monoclonal antibody TF2 | Radiation | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| whole-body scintigraphy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Pharmacokinetics
- measure
- Tissue distribution
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed colorectal cancer * Radiological documentation of disease is preferred, but not required PATIENT CHARACTERISTICS: * Karnofsky performance status 70-100% * Life expectancy ≥ 3 months * WBC ≥ 3,000/mm³ * Neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Serum creatinine normal * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST/ALT \< 2 times ULN * Not pregnant or nursing * Fertile patients must use effective contraception during and for 1 month after completion of study therapy * No medical conditions that might prevent full participation in protocol-required testing or follow-up * No institutionalized patients (e.g., in prisons or mental health institutions) PRIOR CONCURRENT THERAPY: * No concurrent chemotherapy or treatments that would compromise the safety and efficacy of protocol assessments
References
Publications (0)
Data not yet available
No reference posted for this study.