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A Phase I Study of TheraCIM-hR3 (YMB1000) in Patients With Solid Tumours

Phase 1
18 Years
Not Enrolling
Advanced and/or Metastatic Solid Tumours

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Trial Information

A Phase I Study of TheraCIM-hR3 (YMB1000) in Patients With Solid Tumours

This is an open-label, dose-escalating, phase I trial of nimotuzumab in patients with
advanced incurable solid tumors. The objective of this study is to determine the maximum
tolerated dose (MTD) and the recommended phase II dose (RP2D) of nimotuzumab that can be
given in a weekly schedule in patients with advanced and/or metastatic solid tumor cancer.
This study will also examine the safety, pharmacodynamics and preliminary efficacy of
nimotuzumab in this patient population.

Inclusion Criteria:

- Advanced and/or metastatic solid tumors, refractory to standard curative therapy, or
for which no curative therapy exists.

- Clinically or radiologically documented disease. Patients must have measurable
disease, defined as at least one lesion that can be accurately measured in at least
one dimension (longest diameter to be recorded) as > 20 mm with conventional
techniques or as > 10 mm with spiral CT scan.

- Archival tumor specimens evaluable for expression of the EGFR (but EGFR positivity is
not a requirement for study entry).

- Patients must have tumor lesions accessible for biopsy for correlative studies. In
cases where there are medical contraindications to tumor biopsies, exceptions may be
made upon discussion with the Principal Investigators.

- Age > 18 years.

- ECOG performance status of 0,1,2.

- Previous therapy: Previous chemotherapy, hormonal therapy, radiation and/or surgery
is permitted with certain restrictions as outlined in the protocol.

- Hematology and chemistry lab results within specifications outlined in the protocol.

- Willingness to give written informed consent.

- Patients must be accessible for treatment and follow-up.

- Protocol treatment is to begin within 2 working days of patient registration.

Exclusion Criteria:

- Pregnant or lactating women. Both men and women enrolled on study should be using
adequate birth control measures throughout the course of the study.

- History of second malignancy who have a disease-free interval of less than two years
(except cervical cancer in situ or nonmelanomatous skin cancer).

- Untreated brain or meningeal metastases. Patients with treated and stable brain
metastases are eligible providing that they have radiologic evidence of disease
stabilisation of at least 3 months duration and are asymptomatic.

- Untreated and/or uncontrolled cardiovascular conditions and/or have symptomatic
cardiac dysfunction.

- Active or uncontrolled infections, or with serious illnesses or medical conditions
which would not permit the patient to be managed according to the protocol.

- Prior therapy with EGFR targeting therapies, including monoclonal antibodies or small
molecule tyrosine kinase inhibitors.

- Allergy to the antibody.

- Concurrent treatment with other experimental drugs or anti-cancer therapy.

- Inability or unwillingness to give written, informed consent prior to study

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Eric Chen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Toronto


Canada: Health Canada

Study ID:




Start Date:

June 2005

Completion Date:

Related Keywords:

  • Advanced and/or Metastatic Solid Tumours
  • Nimotuzumab
  • TheraCIM
  • H-R3
  • Solid tumours
  • EGFR
  • Monoclonal antibody
  • Neoplasms