Study on the Safety and Effectiveness of REGN7075 and Cemiplimab, with or without Chemotherapy, for Patients with Advanced Solid Tumors

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What is this study about?

This clinical trial is focused on studying advanced forms of cancer, specifically solid tumors, which are abnormal masses of tissue that usually do not contain cysts or liquid areas. The study is investigating the safety and effectiveness of a new treatment combination. The treatment involves a medication called REGN7075, which is a type of protein designed to help the immune system fight cancer, used in combination with another medication called cemiplimab. Cemiplimab is an existing treatment that helps the immune system recognize and attack cancer cells. The study will also explore the effects of adding chemotherapy, which is a type of cancer treatment that uses drugs to destroy cancer cells, to this combination in certain cases.

The purpose of the study is to understand how safe and tolerable the combination of REGN7075 and cemiplimab is for patients with advanced solid tumors. The study will begin with a phase where the doses of the medications are gradually increased to find the safest dose that can be given without causing severe side effects. After this, the study will expand to include more patients to see how well the treatment works in different types of solid tumors. Throughout the study, researchers will monitor the patients for any side effects and measure how the cancer responds to the treatment.

Participants in the study will receive the medications through an infusion, which means the drugs are given directly into the bloodstream through a vein. The study will take place over several years, with the aim of gathering enough information to determine the best way to use these medications together. The ultimate goal is to find a treatment that is both safe and effective for people with advanced solid tumors, potentially offering a new option for those who have not responded well to other treatments.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and performing necessary tests to ensure the patient meets the study criteria.

The patient must have a confirmed diagnosis of advanced solid tumors and meet other specific health criteria.

2 dose escalation phase

In this phase, the patient receives a medication called REGN7075 as a lead-in treatment. This is administered as a solution for injection.

Following the lead-in, REGN7075 is combined with another medication, cemiplimab, which is given as a solution for infusion. The purpose is to determine the safe dosage levels.

3 monitoring and evaluation

Throughout the trial, the patient is closely monitored for any side effects or adverse reactions. Regular blood tests and health assessments are conducted to ensure safety.

The patient’s response to the treatment is evaluated using specific criteria to measure the effectiveness of the medication.

4 dose expansion phase

In this phase, the patient may receive REGN7075 and cemiplimab with or without additional chemotherapy, depending on the specific cohort they are assigned to.

The goal is to further assess the effectiveness of the treatment in a larger group of patients.

5 follow-up

After completing the treatment phases, the patient enters a follow-up period where their health and response to the treatment are continuously monitored.

This phase helps gather long-term data on the safety and effectiveness of the treatment.

Who Can Join the Study?

Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which means the patient is fully active or has some symptoms but can carry out light work.
Has cancer confirmed by a doctor through tests like a biopsy, which involves taking a small sample of tissue for examination.
For certain groups in the study: Has never been treated with drugs targeting PD-1/PD-L1, which are proteins involved in the immune system’s response to cancer.
Has at least one tumor that meets the study’s specific requirements.
Is willing to provide a sample of tumor tissue from a new biopsy, which is a procedure to remove a small piece of tissue for testing, from a tumor that has not been treated with radiation before.
Has organs and bone marrow that are working well enough, as determined by the study’s guidelines.
In the opinion of the study doctor, has a life expectancy of at least 3 months.
Is within the age range specified by the study, which includes both male and female participants.

Who Cannot Join the Study?

Patients who have a different type of cancer than the ones being studied, which are called solid tumors.
Patients who are not within the specified age range for the study.
Patients who are not able to understand or follow the study procedures.
Patients who have other serious health conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have allergies to the study medications or their ingredients.
Patients who are taking medications that might interfere with the study treatment.
Patients who have had a recent surgery or are planning to have surgery during the study.
Patients who have an active infection that requires treatment.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Jean Perrin	Clermont Ferrand	France
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
Hospital Universitario De Salamanca	Salamanca	Spain
Hospital Clinico San Carlos	Madrid	Spain
Centre Hospitalier Universitaire De Lille	Lille	France
Centr Georges Francois Leclerc	Dijon	France

Other Sites

Site Name	City	Country
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Centre Antoine Lacassagne	Nice	France
Hospital Universitari General De Catalunya	Sant Cugat Del Valles	Spain
Med Polonia Sp. z o.o.	Poznan	Poland
Hospital Clinic De Barcelona	Barcelona	Spain
Centre Hospitalier Universitaire De Nantes	Nantes	France
Unite De Recherche Clinique HIA Begin	Saint-Mande	France
Netherlands Cancer Institute	Amsterdam	The Netherlands
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Mavx Cqvlydq Mjmitaje Sbbgxjns	Szczecin	Poland
Etalfly Uddjprasztnw Mylbmta Cokswqm Rpiskjldq (ntjhxxe Mnn	Rotterdam	The Netherlands
Nqrmpfjh Ifkedntk Oqropmfnj Ivn Mbaig Sybbddslbnzimdnriapjkilpvpxq Iazxlcfg Bbcwhefj	Cracow	Poland
Czvdzk Llyo Bjhmsl	Lyon	France
Gzqsnp Hqkbftjrscu Unrowgtfnfzbg Pkbjf Pmdrkyrlvak Et Nsuvqroigsmx	Paris	France
Huqcapsw Vjmt djltmihh	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.11.2023
Poland	Not recruiting	01.11.2023
Spain	Not recruiting	01.11.2023
The Netherlands	Not recruiting	01.11.2023

Trial locations

Investigated drugs:

REGN7075 is a special type of medication called a bispecific antibody. It is designed to help the body’s immune system fight cancer by targeting specific proteins found on cancer cells. In this trial, REGN7075 is being tested to see how safe it is and how well it works when used alone or in combination with another medication. The goal is to see if it can help treat advanced solid tumors, which are types of cancer that form in solid organs or tissues.

Cemiplimab is a medication that helps the immune system attack cancer cells. It works by blocking a protein that usually stops the immune system from working properly. By blocking this protein, cemiplimab can help the immune system find and destroy cancer cells more effectively. In this trial, cemiplimab is being used in combination with REGN7075 to see if the two medications together can better treat advanced solid tumors.

Solid Tumors – Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. They can occur in various parts of the body, including organs and bones. These tumors are characterized by the uncontrolled growth of cells that form a solid mass. As they progress, they can invade nearby tissues and organs, potentially causing functional impairments. The growth rate and behavior of solid tumors can vary widely depending on their type and location. Over time, they may spread to other parts of the body through the bloodstream or lymphatic system.

Trial ID:

2022-501234-37-00

Protocol code:

R7075-ONC-2009

NCT ID:

NCT04626635

Trial Phase:

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

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Study on the Safety and Effectiveness of REGN7075 and Cemiplimab, with or without Chemotherapy, for Patients with Advanced Solid Tumors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?