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Experimental cancer drug tested in patients with no other options

NCT ID NCT04550897

Disease control Sponsor: Oslo University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called BM7PE immunotoxin in 14 people with colorectal cancer that had spread and was no longer responding to standard chemotherapy. The goal was to find a safe dose and see if it could help patients live longer. The study was stopped early, so we have limited information on how well it works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BM7PE immunotoxin
What this could lead to
If successful, this could offer a new treatment option for patients with advanced colorectal cancer who have run out of standard therapies.
What could go wrong
The trial was terminated early, so results are limited. It was a small, early-phase study, so safety and effectiveness are not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

14 people

The number who actually took part.

Started

Aug 2020

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

colorectal cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal cancer metastatic

Contacts and locations

Locations

  • Oslo University Hospital

    Oslo, Oslo, 0310, Norway

More trials for these conditions

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