A Phase I Study of the Chimeric Anti-CD40 Monoclonal Antibody ChiLob 7/4 to Treat Advanced Malignancies Refractory to Conventional Anti-cancer Treatment
NCT ID: NCT01561911
Last Updated: 2014-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
29 participants
INTERVENTIONAL
2007-07-31
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NONE
Interventions
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Chi Lob 7/4 (A chimeric monoclonal antibody)
3 patients will receive treatment at each dose level. Escalation from one treatment dose level to another will only be permitted once at least 3 patients have completed treatment without any DLTs. Starting weekly dose of Chi Lob 7/4 will be 0.5mg (giving a total dose per patient of 2mg divided over 4 weeks). Subsequent individual, weekly dose levels of 1.6mg, 5mg, 16mg, 50mg and 160mg (resulting in total patient doses of 6.4mg, 20mg, 64mg 200mg and 640mg respectively). Further dose escalation can continue to 240mg and 320mg dose per week (resulting in 960mg and 1280mg. Patients may be treated at a lower or intermediate dose level to define the MTD/BAD.
Eligibility Criteria
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Inclusion Criteria
* Written informed consent and the ability of the patient to co-operate with treatment and follow up must be ensured and documented.
* Age greater than 18 years.
* Life expectancy of at least 12 weeks.
* World Health Organisation (WHO) performance status of 0-1 (Appendix 1).
* Haematological and biochemical indices (These measurements must be performed within one week prior to the patient going on study.)
* Haemoglobin (Hb) ≥ 9.0 g/dl
* Neutrophils ≥ 1 x 10\^9/L
* Total Lymphocyte count ≥ 0.5 x 10\^9/L
* Platelets (Plts) ≥ 75 x 10\^9/L
* The following baseline liver function tests :
* Serum bilirubin ≤ 1.5 x upper limit of normal (ULN)
* Alanine amino-transferase (ALT) and/or aspartate amino-transferase (AST) ≤ 3 x ULN unless due to tumour in which case up to 5 x ULN is permissible
* The following baseline renal function test:
* calculated creatinine clearance ≥ 40 mL/min (uncorrected value) or isotope clearance measurement ≥ 40mL/min
* Female patients of child-bearing potential are eligible, provided they have a negative serum or urine pregnancy test prior to enrolment and agree to use appropriate medically approved contraception for four weeks prior to entering the trial, during the trial and for six months afterwards.
* Male patients must agree to use appropriate medically approved contraception during the trial and for six months afterwards.
Exclusion Criteria
* Radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy or chemotherapy during the previous four weeks (six weeks for nitrosoureas and mitomycin-C) prior to treatment.
* All toxic manifestations of previous treatment must have resolved. Exceptions to this are alopecia or certain Grade 1 toxicities which in the opinion of the Investigator and Cancer Research UK should not exclude the patient.
* Pregnant and lactating women are excluded.
* Major thoracic and/or abdominal surgery in the preceding four weeks from which the patient has not yet recovered.
* Patients with primary brain tumours or clinically apparent brain metastases.
* Patients who are high medical risks because of non-malignant systemic disease including active uncontrolled infection.
* Patients with any other condition which in the Investigator"s opinion would not make the patient a good candidate for the clinical trial.
* Patients known to be serologically positive for Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV).
* Long term immunosuppression or steroids (for more than one month)
* History of significant and serious allergy.
* Concurrent congestive heart failure or prior history of class III/ IV cardiac disease (New York Heart Association \[NYHA\] - refer to Appendix 4)
* Patients with low grade or transformed non-Hodgkin"s lymphoma.
* Prior treatment with murine monoclonal antibodies. (Prior treatment with chimeric or fully human antibodies will not exclude a patient).
* A history of clinically significant autoimmune disease.
* Current malignancies at other sites, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for five years and are deemed at low risk for recurrence, are eligible for the study.
18 Years
ALL
No
Sponsors
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Cancer Research UK
OTHER
Responsible Party
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Principal Investigators
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Peter W Johnson, Professor
Role: PRINCIPAL_INVESTIGATOR
Cancer Research UK Medical Oncology Unit, Southampton General Hospital,
Locations
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Cancer Research UK Institute for Cancer Studies, University of Birmingham
Edgbaston, Birmingham, United Kingdom
Cancer Research UK Medical Oncology Unit, Southampton General Hospital
Tremona Road,, Southampton, United Kingdom
Countries
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References
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Johnson P, Challis R, Chowdhury F, Gao Y, Harvey M, Geldart T, Kerr P, Chan C, Smith A, Steven N, Edwards C, Ashton-Key M, Hodges E, Tutt A, Ottensmeier C, Glennie M, Williams A. Clinical and biological effects of an agonist anti-CD40 antibody: a Cancer Research UK phase I study. Clin Cancer Res. 2015 Mar 15;21(6):1321-8. doi: 10.1158/1078-0432.CCR-14-2355. Epub 2015 Jan 14.
Related Links
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Click here for more information about the study:
Other Identifiers
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PH1/103
Identifier Type: -
Identifier Source: org_study_id