Clinical trial · Interventional
111In-ch806 in Patients With Advanced Tumours Expressing the 806 Antigen
A Phase 1 Single Dose Escalation Trial of ch806 in Patients With Advanced Tumours Expressing the 806 Antigen
NCT00291447CI-TRIAL-00061325completedPhase 1Results postedClinicalTrials.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)
The purpose of this clinical trial is to describe the toxicity, biodistribution, pharmacokinetics and tumour uptake of a single infusion of ch806 (tagged with a trace amount of radioactive 111-Indium: 111In-ch806) in patients with advanced tumours expressing the 806 antigen.
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 |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ch806 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- Patients received a single infusion of 5 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion.
- interventionNames
- Biological: ch806
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- Patients received a single infusion of 10 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion.
- interventionNames
- Biological: ch806
- type
- EXPERIMENTAL
- label
- Cohort 3
- description
- Patients received a single infusion of 20 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with advanced or metastatic tumours which are positive for 806 antigen expression based on chromogenic in situ hybridization (CISH) or immuno-histochemistry (IHC) of archived tumour samples. * Histologically or cytologically proven malignancy. * Measurable disease on CT scan with at least one lesion \>/= 2 cm diameter (to allow adequate imaging). * Age greater than or equal to 18 years. * Karnofsky performance scale \>/= 70. * Within the last 2 weeks vital laboratory parameters should be within normal range, except for the following laboratory parameters, which should be within the ranges specified: Neutrophil count \>/= 1.5 x 10\^9/L; Platelet count \>/= 150 x 10\^9/L; Serum bilirubin \< 34 micromol/L; Creatinine clearance \> 50ml/min * Able and willing to give valid written informed consent. Exclusion Criteria: * Untreated active metastatic disease to the central nervous system (new or enlarging lesions on CT or MRI), or within 3 months of treatment (i.e. surgery or radiotherapy) for brain metastases. Primary central nervous system tumour (e.g. Glioblastoma Multiforme) is not an exclusion criterion. * Other serious illnesses, e.g., serious infections requiring antibiotics, bleeding disorders. * Chemotherapy, radiation therapy, or immunotherapy within 4 weeks before study entry (6 weeks for nitrosoureas). * Clinically significant cardiac disease (New York Heart Association Class III/IV). * Other malignancy within 3 years prior to entry into the study, except for treated non-melanoma skin cancer and cervical carcinoma in situ. * Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study. * Lack of availability for immunological and clinical follow-up assessments. * Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment. * Pregnancy or breastfeeding. * Women of childbearing potential: Refusal or inability to use effective means of contraception. * Concomitant treatment with systemic corticosteroids except for patients with Glioblastoma. (Topical or inhalational corticosteroids are permitted.) * Prior administration of monoclonal antibody or antibody fragment, and positive human anti-chimeric antibody (HACA) titre.
References
Publications (1)
- BACKGROUNDTherasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000 Feb 2;92(3):205-16. doi: 10.1093/jnci/92.3.205. PMID 10655437