Clinical trial · Interventional
Study of Pretargeted Radioimmunotherapy of a Anti-CEA Bispecific Antibody and Lu177-labeled Peptide in Colorectal Cancer
Phase I Clinical Study of the Feasibility of Pretargeted Radioimmunotherapy of an Anti-CEA Bispecific Antibody and Lu-177-labeled Peptide in Patients With Advanced Colorectal 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)
This study will investigate the toxicity, safety and pharmacokinetics of pretargeted radioimmunotherapy with anti-CEA x anti-hapten bispecific antibody TF2 and Lu-177-labeled di-HSG-DOTA peptide IMP-288. Furthermore, the sensitivity of pretargeted imaging with In-111-labeled IMP-288 as compared to standard methods of tumor detection, and the preliminary efficacy of the therapy.
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 Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IMP-288 labeled with In111 and Lu177 | Drug | — | UNRESOLVED |
| TF2 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Toxicity defined by NCI Common Terminology Criteria for Adverse Events version 3.0
- timeFrame
- first three weeks: daily, thereafter: weekly
Secondary outcomes (1)
- measure
- pharmacokinetics and biodistribution of TF2 and Lu-177-labeled IMP-288, sensitivity of pretargeted imaging with In-111-labeled IMP-288, and tumor response using RECIST criteria
- timeFrame
- Pk/biodistr: first week after administration; imaging: first 5 days after administration of IMP-288-In111; tumor respone: every 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with CEA expressing advanced colorectal tumors for which no standard treatment is available * WHO performance status: 0 or 1 * Having normal hematological function: Neutrophils \> 1.5 x 109/l; Platelet count \> 150 x 109/l, without transfusion during the previous month; Hemoglobin \> 5.6 mmol/l * Total bilirubin \< 2 x upper limit of normal (ULN) * ASAT, ALAT \< 3 x ULN * Serum creatinine \< 2 x ULN * Cockcroft clearance \> 50 ml/min * Negative pregnancy test for women of child¬bearing potential (urine or serum) * Age over 18 years * Ability to provide written informed consent Exclusion Criteria: * Known metastases to the brain * Chemotherapy, external beam radiation or immunotherapy within 4 weeks prior to study. Limited field external beam radiotherapy to prevent pathological fractures is allowed, when unirradiated, evaluable lesions elsewhere are present. * Prior angiogenesis inhibitors within 4 weeks; bevacizumab within 8 weeks * Cardiac disease with New York Heart Association classification of III or IV * Patients who are pregnant, nursing or of reproductive potential and are not practicing an effective method of contraception * Any unrelated illness, e.g. active infection, inflammation, medical condition or laboratory abnormalities, which in the judgement of the investigator will significantly affect patients' clinical status * Life expectancy shorter than 6 months.
References
Publications (0)
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