Phase 1
Completed N=8
111In-ch806 in Patients With Advanced Tumours Expressing the 806 Antigen
Neoplasms
Source: ClinicalTrials.gov NCT00291447 ↗
Enrolled (actual)
8
Serious AEs
37.5%
Results posted
Jun 2021
Primary outcomePrimary: Number of Patients With Adverse Events — 2; 2; 2; 2 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Adverse Events |
2; 2; 2; 2; 0; 0 | — |
| SECONDARY Biodistribution of 111In-ch806 Using Whole Body Clearance Methodology or Biological Halftime (T1/2-biol) Following the First Infusion. |
1258; 931; 915; 689 | — |
| SECONDARY Mean Normal Organ Dosimetry of 111In-ch806 Using Normal Organ Absorbed Dose (mGy/MBq) Following the First Infusion. |
0.370; 0.365; 0.359; 0.3428; 0.504; 0.652 | — |
| SECONDARY Number of Patients With Tumour Uptake of 111In-ch806 Based on Qualitative Assessment of Biodistribution Images and Dosimetry Following the First Infusion. |
2; 2; 2; 2 | — |
| SECONDARY Mean Half-life as Measured by Half-life of Initial Phase of Disposition (T½α) and Terminal Phase of Distribution (T½β) of 111In-ch806 Following the First Infusion . |
10.91; 11.75; 9.34; 8.95; 183.9; 124.5 | — |
| SECONDARY Mean Volume of the Central Compartment (V1) of 111In-ch806 Following the First Infusion. |
2963.06; 3060.29; 2902.06; 4742.42 | — |
| SECONDARY Mean Total Serum Clearance (CL) of 111In-ch806 Following the First Infusion. |
21.97; 28.58; 30.98; 37.99 | — |
| SECONDARY Mean Area Under the Serum Concentration Curve (AUC) of 111In-ch806 Following the First Infusion. |
541.17; 566.79; 1438.12; 2269.04 | — |
| SECONDARY Number of Subjects With Best Overall Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) |
1; 2; 1; 1; 1; 0 | — |
| SECONDARY Number of Patients With Human Anti-chimeric ch806 Antibodies (HACA) |
1; 0; 0; 0; 1; 2 | — |
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT00291447). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.