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

Program Status

Recruiting

Phase

Phase 1

Prior Immunotherapy Allowed

Yes

CRC-directed Trial

Yes

Drugs

BM7PE

Tags

MSI-H/ MMRd, MSS/ MMRp

Comments

Trial in Norway. For colorectal cancer patients with metastatic disease who are refractory to or with intolerance to last line of standard chemotherapy.
BM7PE: An immunoconjugate containing BM7, a murine monoclonal antibody directed against the human tumor-associated antigen (TAA) mucin-1 (MUC1; MUC-1) covalently linked to the bacterial toxin Pseudomonas exotoxin A (PE), with potential antitumor activity.
 

Location Location Status
Norway
Oslo University Hospital
Oslo 0310
Recruiting

Contacts

Geir O Hjortland, MD PhD
Contact
22934000 goo@ous-hf.no

Inclusion 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

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.

NCT ID

NCT04550897

Date Trial Added

2020-09-16

Updated Date

2023-03-22