A Phase I Study of the Chimeric Anti-CD40 Monoclonal Antibody ChiLob 7/4 to Treat Advanced Malignancies Refractory to Conventional Anti-cancer Treatment

PHASE1CompletedINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

July 31, 2007

Primary Completion Date

October 31, 2014

Study Completion Date

October 31, 2014

Conditions
CancerNeoplasmsLymphomaNon-HodgkinB-Cell
Interventions
DRUG

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.

Trial Locations (2)

B15 2TT

Cancer Research UK Institute for Cancer Studies, University of Birmingham, Edgbaston

SO16 6YD

Cancer Research UK Medical Oncology Unit, Southampton General Hospital, Tremona Road,

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Cancer Research UK

OTHER