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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Colorectal Cancer Metastatic

Intervention / Treatment
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* Drug: BM7PE


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Phase 1 study in colorectal cancer patients
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BM7PE treatment<br>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<br>* BM7PE immunotoxin is supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events related to BM7PE | To characterize the safety and toxicity of BM7PE by register adverse event in accordance with CTCAE 5.0 | 30 days after last dose of BM7PE | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of the BM7PE: Overall survival | The Overall survival will be measured by death registration | Through study completion, an average of 1 year | 
| Efficacy of the BM7PE: progression free survival | The progression free survival will be measured by MR (RECIST 1.1) | 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 | 
| Radiological response to BM7PE | Will be measured by CT (RECIST 1.1) response rate | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intolerance last line standard chemotherapy