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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer Metastatic
• Intervention / Treatment: Drug: BM7PE

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Geir O Hjortland, MD PhD; Phone Number: 22934000; Email: goo@ous-hf.no

Study Locations

• Norway
  • Oslo, Norway, 0310
    • Recruiting
    • Oslo University Hospital
    • Contact: Geir O Hjortland, MD PhD; Phone Number: 47 22934000; Email: goo@ous-hf.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Geir O Hjortland, MDPhD, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: August 31, 2020
• First Submitted That Met QC Criteria: September 15, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Intolerance last line standard chemotherapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: BM7PE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No