Study of petosemtamab alone or with drug combination for patients with advanced colorectal cancer and other solid tumors

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What is this study about?

This study focuses on treating patients with metastatic colorectal cancer and other advanced solid tumors. The main treatment being investigated is petosemtamab (also known as MCLA-158), which can be given either alone or combined with other medications. The additional medications that may be used in combination include pembrolizumab (KEYTRUDA), oxaliplatin, irinotecan, fluorouracil, and calcium folinate.

The purpose of this research is to evaluate how well patients respond to the treatment and to understand the safety of petosemtamab when used alone or in combination with other medications. The study is designed in two parts: the first part determines the right dose of the medication, while the second part tests the treatment in larger groups of patients.

During the study, participants will receive their assigned treatment through intravenous administration (delivery of medication directly into a vein). The medications will be given according to a specific schedule determined by the study protocol. Throughout the treatment period, patients will be monitored for their response to the therapy and any side effects that may occur.

1 Initial treatment preparation

The treatment involves receiving multiple medications through intravenous administration (delivery directly into a vein)

A healthcare provider will assess your general health condition and confirm your ECOG performance status (a measure of your ability to perform daily activities) is at level 0 or 1

2 Treatment administration

You will receive a combination of medications through intravenous infusion:

– Petosemtamab (MCLA-158)

– Pembrolizumab (Keytruda)

– Calcium folinate

– Irinotecan

– Fluorouracil

– Oxaliplatin

3 Monitoring period

Regular assessments will track your response to treatment

Healthcare providers will monitor for any side effects or adverse reactions

Your tumor response will be evaluated to determine if the treatment is effective

4 Ongoing evaluation

Regular checks of your overall health status

Assessment of how long the treatment keeps working (Duration of Response)

Monitoring of how long you remain without disease progression (Progression-Free Survival)

The study continues until November 2027

Who Can Join the Study?

Patient must sign an informed consent form before any study procedures begin
Must be at least 18 years old when signing the consent form
For first-line head and neck cancer patients: Must be eligible for pembrolizumab (an immunotherapy drug) treatment and have tumors that express PD-L1 (a specific protein) with a CPS score of 1 or higher
For second/third-line head and neck cancer patients: Must have either:
– Had cancer progression after receiving immunotherapy (anti-PD-(L)1 therapy), or
– Been unable to tolerate immunotherapy, and
– Had cancer progression after receiving platinum-based chemotherapy
For colorectal cancer patients:
– Must have confirmed diagnosis of colon or rectal cancer that has spread (metastatic) or cannot be surgically removed
– Must have normal RAS/RAF genes (not mutated)
– Must not have received previous anti-EGFR therapy (a type of targeted treatment)
Must have good physical function status (ECOG score of 0 or 1, meaning able to perform daily activities with minimal assistance)
Must have adequate heart and organ function

Who Cannot Join the Study?

Prior treatment with EGFR (a protein involved in cell growth) targeting therapy in the last 4 weeks before starting the study
Active or untreated brain metastases (cancer that has spread to the brain)
History of another cancer within the past 3 years, except for successfully treated non-melanoma skin cancer or cervical cancer in situ (early-stage cancer)
Severe heart conditions, including:
– Heart attack within past 6 months
– Unstable angina (chest pain)
– Heart failure requiring treatment
Active, uncontrolled infections requiring treatment
Known positive test for HIV, hepatitis B, or hepatitis C
Major surgery within 4 weeks before starting the study
Pregnant or breastfeeding women
Any condition that, in the opinion of the study doctor, would make participation unsafe
Unable to swallow oral medications
Severe kidney or liver problems
Current participation in other clinical trials

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Hospital Universitario De Navarra	Pamplona	Spain
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Aix Marseille University	Marseille	France
Institut Curie – Site Paris	Paris	France

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Institut Jules Bordet	Anderlecht	Belgium
Universitair Ziekenhuis Gent	Gent	Belgium
Hospital Universitario 12 De Octubre	Madrid	Spain
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur	Namur	Belgium
Centre Henri Becquerel	Rouen	France
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Netherlands Cancer Institute	Amsterdam	The Netherlands
Cnslqhesz Uifflpeluwskyy Swbrugmjy	Woluwe-Saint-Lambert	Belgium
Ibdyohjw Rgvwliri Dv Cgckki Di Muwivhqmbrq	Montpellier	France
Ctgbwn Ldts Bvphtl	Lyon	France
Sqdbfeesb Rkpifrd Ulxtznvlcx Maucsyv Cdfbjj	Nijmegen	The Netherlands
Hqpgnivq Vucl dvsdeqml	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	12.03.2018
France	Recruiting	12.03.2018
Italy	Recruiting	12.03.2018
Spain	Recruiting	12.03.2018
The Netherlands	Recruiting	12.03.2018

Trial locations

Investigated drugs:

Petosemtamab (also known as MCLA-158) is a medication being studied for treating advanced solid tumors. It is an experimental treatment that works by targeting specific proteins on cancer cells. This medication is being tested both as a standalone treatment and in combination with other therapies to determine how well it works against various types of solid tumors.

Metastatic Colorectal Cancer – A condition where cancer that begins in the colon or rectum spreads to other parts of the body. The disease starts in the inner lining of the colon or rectum and can grow through several layers. Cancer cells can break away from the original tumor and travel through blood or lymph vessels to form new tumors in other organs. Common areas where colorectal cancer spreads include the liver, lungs, and peritoneum.

Malignant Solid Tumor – A type of cancer that forms a mass of tissue without liquid or cysts. These abnormal cell growths can develop in various body tissues and organs. Solid tumors can increase in size and may spread to nearby tissues. The cells in these tumors multiply uncontrollably and can develop their own blood vessel network to support their growth. Unlike liquid cancers, these tumors form distinct masses that can often be felt or seen on imaging tests.

Trial ID:

2024-513627-16-01

Protocol code:

MCLA-158-CL01

NCT ID:

NCT03526835

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study of petosemtamab alone or with drug combination for patients with advanced colorectal cancer and other solid tumors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?