Study of Patritumab Deruxtecan for Patients with Advanced or Metastatic Solid Tumors

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What is this study about?

This clinical trial is focused on studying the effects of a treatment called Patritumab deruxtecan, also known by its code name HER3-DXd, on patients with locally advanced or metastatic solid tumors. These are types of cancers that have either spread to nearby areas or to other parts of the body and cannot be removed by surgery or treated with radiation. The purpose of the study is to evaluate how effective this treatment is for these types of tumors.

Participants in the study will receive Patritumab deruxtecan as a solution through an intravenous infusion, which means it will be administered directly into the bloodstream. The study will take place over a period of time, during which participants will have regular visits to receive the treatment and undergo various tests to monitor their health and the effects of the treatment. The study aims to gather information on how well the treatment works and any side effects that may occur.

Throughout the study, researchers will be looking at several outcomes, such as how long the treatment keeps the cancer from getting worse, how long any positive effects last, and the overall survival of participants. The study will also explore the relationship between the presence of a protein called HER3 in the tumors and the effectiveness of the treatment. This information will help in understanding the potential benefits of Patritumab deruxtecan for patients with these types of cancers.

1 joining the study

Upon joining the study, the participant will sign and date the informed consent form (ICF) before any study-specific procedures begin.

A separate consent for tissue screening will be obtained to meet the baseline tumor tissue requirement.

2 initial screening

The participant will undergo initial screening to confirm eligibility, which includes providing a pretreatment tumor tissue sample and undergoing imaging tests like CT or MRI to identify measurable lesions.

The participant’s performance status will be assessed using the Eastern Cooperative Oncology Group (ECOG) scale, and adequate bone marrow and organ function will be confirmed through laboratory tests.

3 treatment administration

The participant will receive the study medication, patritumab deruxtecan, administered as an intravenous infusion.

The dosage and frequency of administration will be determined by the study protocol, and the treatment will continue as specified in the study guidelines.

4 monitoring and assessments

Throughout the study, the participant will attend scheduled visits for monitoring and assessments, which include laboratory tests and imaging to evaluate the response to treatment.

The primary endpoint is the overall response rate (ORR) as assessed by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

5 safety evaluations

Safety evaluations will be conducted to monitor for any treatment-emergent adverse events (TEAEs) and other safety parameters.

The participant’s health and response to the medication will be closely observed to ensure safety throughout the study.

6 study completion

The study is estimated to end by October 31, 2026, with recruitment starting on May 29, 2024.

Upon completion, the participant’s overall survival and progression-free survival will be evaluated, along with other secondary endpoints such as duration of response and clinical benefit rate.

Who Can Join the Study?

Sign and date the consent form before starting any study-specific procedures. A separate consent for tissue screening is required to meet the baseline tumor tissue requirement.
If you are male, you must be surgically sterile or willing to use highly effective birth control during the study and for at least 4 months after the last dose of the study drug.
Male participants must not freeze or donate sperm from the start of the study until at least 4 months after the final dose of the study drug.
Be willing and able to attend scheduled visits, follow the drug administration plan, undergo laboratory tests, and comply with other study procedures and restrictions.
Participate in the Phase II open-label study.
Provide consent to participate in an interview sub-study through the consent form.
Agree to be audio recorded.
Live in Belgium, Spain, Japan, Korea, Taiwan, continental US (excluding Puerto Rico), UK, or Australia.
Be able to communicate and read fluently in the local language, such as Belgian-French, Spanish, Japanese, Korean, Taiwanese-Mandarin, or English.
Be physically able to participate in a one-on-one, approximately 45-minute telephone interview using an internet-enabled device with screen-sharing capabilities.
Be at least 18 years old (or older if local regulations require a higher age for consent).
Have locally advanced unresectable or metastatic disease, which means the disease cannot be cured by surgery or radiation.
Have at least one measurable lesion on a CT or MRI scan as assessed by the investigator.
Provide a pretreatment tumor tissue sample of sufficient quantity.
Have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at screening, which indicates your ability to perform daily activities.
Have adequate bone marrow reserve and organ function based on local laboratory data within 14 days before starting the study.
If you are a female of childbearing potential, you must have a negative pregnancy test at screening and be willing to use highly effective birth control during the study and for 7 months after the last dose of the study drug.
Female participants must not donate or retrieve eggs for their own use from the start of the study until 7 months after the final dose of the study drug.

Who Cannot Join the Study?

Patients with other types of cancer that are not locally advanced or metastatic solid tumors cannot participate. Locally advanced means the cancer has spread from where it started to nearby tissue or lymph nodes. Metastatic means the cancer has spread to other parts of the body.
Patients who have received certain treatments for their cancer recently may not be eligible.
Patients with certain medical conditions that could interfere with the study treatment may be excluded.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are unable to follow the study procedures or attend study visits may not be eligible.
Patients with a history of severe allergic reactions to similar drugs may be excluded.
Patients with uncontrolled infections or other serious illnesses may not be eligible.
Patients who have participated in another clinical trial recently may not be eligible.

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
Oncopole Claudius Regaud	Toulouse	France
Centr Georges Francois Leclerc	Dijon	France
Oslo Universitetssykehus HF	Oslo	Norway
Institut De Cancerologie De Lorraine	Vandoeuvre Les Nancy	France
IRCCS Humanitas Research Hospital	Rozzano	Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France
University Hospital Maastricht	Maastricht	The Netherlands
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Krankenhaus Nordwest GmbH	Frankfurt	Germany
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Universitair Ziekenhuis Gent	Gent	Belgium
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Tolna Vármegyei Balassa János Kórház	Szekszard	Hungary
University Of Debrecen	Debrecen	Hungary
Hospital Clinic De Barcelona	Barcelona	Spain
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Semmelweis University	Budapest	Hungary
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz	Miskolc	Hungary
Centre Hospitalier Universitaire De Nantes	Nantes	France
Cliniche Gavazzeni S.p.A.	Bergamo	Italy
Vrije Universiteit Brussel	Jette	Belgium
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Clsmpdxhi Uxqelpvskhzdjg Skkxtloco	Woluwe-Saint-Lambert	Belgium
Cgjxbi Lpus Bxbvdy	Lyon	France
Uhpymnrwtpbvtdlenxdhu Esavz Asw	Essen	Germany
Lxqzl Uwqgmniwrdon Mwtfzye Ccyetiq (yciqx	Leiden	The Netherlands
Ucpuwxyzgwbl Mzdkium Crljyxe Gttvqnijl	Groningen	The Netherlands
Bqydidxlfpo Vdatzgkib Osfzrnbnskey	Kecskemet	Hungary
Avernyany Umo	Amsterdam	The Netherlands
Asgfqbgdve Pyxadcrv Harhienv Dw Mwenhkalh	Marseille	France
Ayfeqafd Uhkxxjafxn Hoyuocwm	Lorenskog	Norway
Hkvql Bqqfpy Hm	Bergen	Norway
Acblljw Uuvhe Slxrpzojx Lkkidl Do Bjxmpgb	Bologna	Italy
Hfdjvaty Dt Lf Swibg Cquy I Sugs Pzw	Barcelona	Spain
Utwdxhsvtt Ov Azoslmg	Edegem	Belgium
Hruwnino Vctb dkjakuci	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	29.05.2024
France	Recruiting	29.05.2024
Germany	Recruiting	29.05.2024
Hungary	Recruiting	29.05.2024
Italy	Recruiting	29.05.2024
Norway	Recruiting	29.05.2024
Spain	Recruiting	29.05.2024
The Netherlands	Recruiting	29.05.2024

Trial locations

Investigated drugs:

Patritumab Deruxtecan

Patritumab Deruxtecan (HER3-DXd) is a medication being studied for its effectiveness in treating advanced or metastatic solid tumors. It is designed to target and deliver cancer-fighting agents directly to the tumor cells, potentially reducing the growth of the cancer. This study aims to understand how well this medication works when used alone in patients with specific types of advanced cancers.

Investigated diseases:

Neoplasm

Locally Advanced or Metastatic Solid Tumors – These are cancers that have either spread extensively within the local area or have metastasized to other parts of the body. In locally advanced cases, the tumor has grown significantly but remains within the region of origin, often involving nearby tissues or lymph nodes. Metastatic tumors have spread from the primary site to distant organs or tissues, indicating a more advanced stage of cancer. The progression of these tumors can vary widely depending on the type of cancer and its location. They often lead to symptoms related to the affected organs and can impact overall health and function. The behavior and growth rate of these tumors can differ, influencing how they affect the body over time.

Trial ID:

2023-507641-29-00

Protocol code:

U31402-277

NCT ID:

NCT06172478

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Patritumab Deruxtecan for Patients with Advanced or Metastatic Solid Tumors

What is this study about?

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