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A Phase I/II Study With BM7PE Immunotoxin in Colorectal Cancer Patients (BM7PE)

Primary Purpose

Colorectal Cancer Metastatic

Status
Recruiting
Phase
Phase 1
Locations
Norway
Study Type
Interventional
Intervention
BM7PE
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Colorectal Cancer Metastatic focused on measuring Intolerance last line standard chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Oslo University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BM7PE treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

Adverse Events related to BM7PE
To characterize the safety and toxicity of BM7PE by register adverse event in accordance with CTCAE 5.0

Secondary Outcome Measures

Efficacy of the BM7PE: Overall survival
The Overall survival will be measured by death registration
Efficacy of the BM7PE: progression free survival
The progression free survival will be measured by MR (RECIST 1.1)
Radiological response to BM7PE
Will be measured by CT (RECIST 1.1) response rate

Full Information

First Posted
August 31, 2020
Last Updated
March 21, 2023
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04550897
Brief Title
A Phase I/II Study With BM7PE Immunotoxin in Colorectal Cancer Patients
Acronym
BM7PE
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Metastatic
Keywords
Intolerance last line standard chemotherapy

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Phase 1 study in colorectal cancer patients
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BM7PE treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
BM7PE
Intervention Description
BM7PE immunotoxin is supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml.
Primary Outcome Measure Information:
Title
Adverse Events related to BM7PE
Description
To characterize the safety and toxicity of BM7PE by register adverse event in accordance with CTCAE 5.0
Time Frame
30 days after last dose of BM7PE
Secondary Outcome Measure Information:
Title
Efficacy of the BM7PE: Overall survival
Description
The Overall survival will be measured by death registration
Time Frame
Through study completion, an average of 1 year
Title
Efficacy of the BM7PE: progression free survival
Description
The progression free survival will be measured by MR (RECIST 1.1)
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
Title
Radiological response to BM7PE
Description
Will be measured by CT (RECIST 1.1) response rate
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Geir O Hjortland, MD PhD
Phone
22934000
Email
goo@ous-hf.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geir O Hjortland, MDPhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0310
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geir O Hjortland, MD PhD
Phone
22934000
Ext
47
Email
goo@ous-hf.no

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Phase I/II Study With BM7PE Immunotoxin in Colorectal Cancer Patients

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