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

• ClinicalTrials.gov Identifier: NCT04550897
• Recruitment Status: Recruiting
• First Posted: September 16, 2020
• Last Update Posted: February 17, 2021
• Sponsor: Oslo University Hospital
• Information provided by (Responsible Party): Geir Olav Hjortland, Oslo University Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Colorectal Cancer Metastatic	Drug: BM7PE	Phase 1; Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Phase 1 study in colorectal cancer patients
• Masking: None (Open Label)
• Primary Purpose: Other
• 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.
• Actual Study Start Date: August 31, 2020
• Estimated Primary Completion Date: December 31, 2022
• Estimated Study Completion Date: December 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Adverse Events related to BM7PE [ Time Frame: 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 :

1. Efficacy of the BM7PE: Overall survival [ Time Frame: Through study completion, an average of 1 year ]
   The Overall survival will be measured by death registration
2. Efficacy of the BM7PE: progression free survival [ Time Frame: 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)
3. Radiological response to BM7PE [ Time Frame: 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

Eligibility Criteria

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

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.

Contacts and Locations

Contacts

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

Locations

Norway

Oslo University Hospital; Recruiting

Oslo, Norway, 0310

Contact: Geir O Hjortland, MD PhD 22934000 ext 47 goo@ous-hf.no

Sponsors and Collaborators

Oslo University Hospital

Investigators

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

More Information

• Responsible Party: Geir Olav Hjortland, Principal Investigator, Oslo University Hospital
• ClinicalTrials.gov Identifier: NCT04550897
• Other Study ID Numbers: BM7PE
• First Posted: September 16, 2020
• Last Update Posted: February 17, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Geir Olav Hjortland, Oslo University Hospital:

Intolerance last line standard chemotherapy

Additional relevant MeSH terms:

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases