111In-ch806 in Patients With Advanced Tumours Expressing the 806 Antigen

NCT00291447 | Completed Phase 1 Results

• 1 other identifier: LUD2004-001
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Adverse Events

  All AEs occurring during the study were documented on the respective case report form (CRF) pages. Events, which occurred after signed informed consent, but before first administration of study drug, were documented on the Pre-existing Signs and Symptom page. Thereafter, they were documented on the Adverse Event page. Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Documentation of AEs includes: date and time of onset and resolution, severity, frequency, seriousness, related interventions and outcome. Dose limiting toxicity (DLT) was defined as any Grade 2 or greater allergic reaction related to 111In-ch806 antibody protein, and any Grade 4 haematological or Grade 3 or greater non-haematological toxicity except for skin rash, occurring within 30 days of the 111In-ch806 infusion.

  30 days

Secondary Outcomes (9)

• Biodistribution of 111In-ch806 Using Whole Body Clearance Methodology or Biological Halftime (T1/2-biol) Following the First Infusion.

  Day 0 (1-4 hours after 111In-ch806 infusion), and on Day 1, Day 2 or 3, Day 4 or 5, and Day 6 or 7 post 111In-ch806 infusion.

• Mean Normal Organ Dosimetry of 111In-ch806 Using Normal Organ Absorbed Dose (mGy/MBq) Following the First Infusion.

  Day 0 (1-4 hours after 111In-ch806 infusion), and on Day 1, Day 2 or 3, Day 4 or 5, and Day 6 or 7 following 111In-ch806 infusion.

• Number of Patients With Tumour Uptake of 111In-ch806 Based on Qualitative Assessment of Biodistribution Images and Dosimetry Following the First Infusion.

  Day 0 (1-4 hours after 111In-ch806 infusion), Day 1, Day 2 or 3, Day 4 or 5, and Day 6 or 7 following 111In-ch806 infusion.

• 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 .

  Day 0 - pre 111In-ch806 infusion; then at 5 minutes, 60 minutes, 2 hours and 4 hours post 111In-ch806 infusion, Day 1, Day 2 or 3, Day 4 or 5, Day 6 or 7, Day 14 (± 2 days) and Day 21 (± 2 days) and Day 30 (± 2 days) post infusion.

• Mean Volume of the Central Compartment (V1) of 111In-ch806 Following the First Infusion.

  Day 0 - pre 111In-ch806 infusion; then at 5 minutes, 60 minutes, 2 hours and 4 hours post 111In-ch806 infusion, Day 1, Day 2 or 3, Day 4 or 5, Day 6 or 7, Day 14 (± 2 days) and Day 21 (± 2 days) and Day 30 (± 2 days) post infusion.

Study Arms (4)

Cohort 1

EXPERIMENTAL

Patients received a single infusion of 5 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion.

Biological: ch806

Cohort 2

EXPERIMENTAL

Patients received a single infusion of 10 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion.

Biological: ch806

Cohort 3

EXPERIMENTAL

Patients received a single infusion of 20 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion.

Biological: ch806

Cohort 4

EXPERIMENTAL

Patients received a single infusion of 40 mg/m2 111In-ch806 on Day 0 and followed for 30 days post infusion.

Biological: ch806

Interventions

ch806 BIOLOGICAL

ch806 is a chimeric (part human, part mouse) antibody which recognizes and attaches to a protein called the 806 antigen (a type of EGFR), which is found on the surface of some cancer cells.

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ludwig Institute for Cancer Research: lead

Study Sites (1)

Ludwig Institute Tumor Targeting Program, Austin Health

Heidelberg, Victoria, 3084, Australia

Location

Related Publications (1)

• Therasse 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 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Interventions

monoclonal antibody 806

Results Point of Contact

• Title: Jonathan Skipper PhD
• Organization: Ludwig Institute for Cancer Research

jskipper@lcr.org

12124501539

Study Officials

• A/Prof Andrew M Scott, MBBS MD DDU

  Ludwig Institute for Cancer Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label, single dose escalation Phase I trial of ch806 in patients with advanced tumors expressing the 806 antigen.

Study Record Dates

• First Submitted: February 10, 2006
• First Posted: February 14, 2006
• Study Start: May 1, 2005
• Primary Completion: February 16, 2006
• Study Completion: August 10, 2006
• Last Updated: October 10, 2022
• Results First Posted: June 8, 2021

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)