A Phase I/II Study With BM7PE Immunotoxin in Colorectal Cancer Patients
- Registration Number
- NCT04550897
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BM7PE treatment BM7PE 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.
- Primary Outcome Measures
Name Time Method Adverse Events related to BM7PE 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
Name Time Method Radiological response to BM7PE 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
Efficacy of the BM7PE: Overall survival Through study completion, an average of 1 year The Overall survival will be measured by death registration
Efficacy of the BM7PE: progression free survival 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)
Trial Locations
- Locations (1)
Oslo University Hospital
🇳🇴Oslo, Norway