Study of Ticilimumab in Patients With Metastatic Colorectal Cancer Whose Disease Had Progressed After Treatment

Phase 2, Single Arm Study Of Ticilimumab In Patients With Refractory Metastatic Adenocarcinoma Of The Colon Or Rectum

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00313794

Enrollment

Registered

2006-04-12

Start date

2006-05-31

Completion date

2008-06-30

Last updated

2012-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Neoplasms

Brief summary

This study is for patients with metastatic adenocarcinoma arising from the colon or rectum who have received treatment(s) for metastatic disease with subsequent disease progression. Patients who are intolerant to treatment(s) are also included. This is a study for good performance status colorectal cancer patients who have exhausted standard therapy options.

Interventions

DRUGCP-675,206

15 mg/kg IV q 3 months for 4 cycles in the absence of disease progression or unacceptable toxicity.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Radiographic evidence of metastatic, progressive disease following standard therapies. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

Exclusion criteria

* Known brain metastases or uncontrolled pleural effusions. * History of chronic inflammatory or autoimmune disease.

Design outcomes

Primary

Measure	Time frame
To assess the best overall response rate per RECIST (BRR) in patients with metastatic adenocarcinoma of the colon or rectum treated with CP-675,206 .	18 months

Secondary

Measure	Time frame
To evaluate the safety and tolerability of CP-675,206 in this population.	18 mos
To identify any human anti human antibody (HAHA) response to CP-675,206 .	3 yrs
To identify potential relationships between polymorphisms in the Cytotoxic T lymphocyte-associated antigen 4 (CTLA4), Fcgamma receptor IIa (FcgRIIa), IgG2a genes with safety and/or immune response of patients treated with CP-675,206.	3 yrs
To assess additional evidence of anti-tumor activity as measured by duration of response, progression-free survival and overall survival.	2 yrs
To obtain pharmacokinetic (PK) data to be evaluated in a future meta analysis of CP-675,206 pharmacokinetics.	3 yrs

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026