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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 : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Svein Dueland, Oslo University Hospital

Brief Summary:
This phase 1/2 study will evaluate the safety, tolerance and dose of BM7PE treating patients with colorectal cancer who have progressed to standard cell therapy or cannot tolerate such therapy. The study starts as a phase 1 study with the aim of assessing the final dose for this group of patients. Based on the results, the study will continue into a phase 2. The phase 2 study aim to examine overall survival ≥ 9.3 months.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Metastatic Drug: BM7PE Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Phase 1 study in colorectal cancer patients
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

Drug: BM7PE
BM7PE immunotoxin is supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Efficacy of the BM7PE: Overall survival [ Time Frame: Through study completion, an average of 1 year ]
    The Overall survival will be meassured by death registration

  2. 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 meassured by MR (RECIST 1.1)

  3. 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 meassured by CT (RECIST 1.1) response rate



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically verified adenocarcinoma of colon or rectum
  • Ambulatory with an ECOG performance status 0-1
  • At least 18 years of age
  • Progressive disease on or last line of standard chemotherapy or intolerance to further chemotherapy
  • Laboratory values as the following: ANC, Platelets, Hb, Creatinine, Bilirubin, ASAT, ALAT, Albumin levels, INR
  • Signed informed consent and expected cooperation of the patients for the treatment, and follow-up must be obtained and documented according to ICH GCP, and national/local regulations

Exclusion Criteria:

  • History of prior metastatic disease the last 3 years
  • History of CNS or bone metastases
  • Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia
  • Chemotherapy/radiation therapy or major surgery within the last 4 weeks before start of treatment
  • Alcohol or drug abuse
  • Any reason why, in the opinion of the investigator, the patient should not participate
  • Has a known history of Human Immunodeficiency Virus (HIV)
  • Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected)
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the project duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.

Information from the National Library of Medicine

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


Contacts
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Contact: Dueland 22934000 svein.dueland@ous-hf.no

Locations
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Norway
Oslo University Hospital Recruiting
Oslo, Norway, 0310
Contact: Svein Dueland, MD    22934000 ext 47    svein.dueland@ous-hf.no   
Sponsors and Collaborators
Oslo University Hospital
Investigators
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Principal Investigator: Svein Dueland, MDPhD Oslo University Hospital
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Responsible Party: Svein Dueland, Principal Investigator, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT04550897    
Other Study ID Numbers: BM7PE
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Svein Dueland, Oslo University Hospital:
Iintolerance last line standard chemotherapy
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases