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

Colorectal Cancer Metastatic Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04550897
• Other study ID #: BM7PE
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: August 31, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Oslo University Hospital
• Contact: Geir O Hjortland, MD PhD
• Phone: 22934000
• Email: goo[@]ous-hf.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer Metastatic
• Colorectal Neoplasms

Intervention

Drug:
• BM7PE
BM7PE immunotoxin is supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml.

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Efficacy of the BM7PE: Overall survival	The Overall survival will be measured by death registration	Through study completion, an average of 1 year
Secondary	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
Secondary	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