A Phase I/II Study With BM7PE Immunotoxin in Colorectal Cancer Patients (BM7PE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04550897|
Recruitment Status : Recruiting
First Posted : September 16, 2020
Last Update Posted : February 17, 2021
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Metastatic||Drug: BM7PE||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Phase 1 study in colorectal cancer patients|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1/2 Study With BM7PE Immunotoxin in Colorectal Cancer Patients With Metastatic Disease Who Are Refractory to or With Intolerance to Last Line of Standard Chemotherapy.|
|Actual Study Start Date :||August 31, 2020|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: BM7PE treatment
The BM7PE treatment will be administered as a 20-minute i.v. infusion. The treatment is repeated after 2 weeks (day 15). The patients will be treated as in-patients and will stay at the hospital until toxicity have decreased to grade 2 and or plasma AST and or ALT levels has started to decrease. For at least a minimum of 3 days.
The dose administered to the patient will be 2.5, 5.0, 7.5, 10.0, 15.0 and 20.0 μg/kg body weight.
BM7PE immunotoxin is supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml.
- Adverse Events related to BM7PE [ Time Frame: 30 days after last dose of BM7PE ]To characterize the safety and toxicity of BM7PE by register adverse event in accordance with CTCAE 5.0
- Efficacy of the BM7PE: Overall survival [ Time Frame: Through study completion, an average of 1 year ]The Overall survival will be measured by death registration
- Efficacy of the BM7PE: progression free survival [ Time Frame: From date of first treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months ]The progression free survival will be measured by MR (RECIST 1.1)
- Radiological response to BM7PE [ Time Frame: From date of first treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months ]Will be measured by CT (RECIST 1.1) response rate
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04550897
|Contact: Geir O Hjortland, MD PhDemail@example.com|
|Oslo University Hospital||Recruiting|
|Oslo, Norway, 0310|
|Contact: Geir O Hjortland, MD PhD 22934000 ext 47 firstname.lastname@example.org|
|Principal Investigator:||Geir O Hjortland, MDPhD||Oslo University Hospital|