Clinical trial NCT04550897: A Phase I/II Study With BM7PE Immunotoxin in Colorectal Cancer Patients
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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Colorectal Cancer Metastatic
Keywords: Intolerance last line standard chemotherapy
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Phase 1 study in colorectal cancer patients
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Adverse Events related to BM7PE
timeFrame: 30 days after last dose of BM7PE
Secondary outcomes:
measure: Efficacy of the BM7PE: Overall survival
timeFrame: Through study completion, an average of 1 year
measure: Efficacy of the BM7PE: progression free survival
timeFrame: 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
measure: Radiological response to BM7PE
timeFrame: 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
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Geir O Hjortland, MDPhD
role: PRINCIPAL_INVESTIGATOR
References: