RecruitingPhase 2NCT07407465

Upfront Trastuzumab-Deruxtecan Plus Capecitabine and Bevacizumab for Patients With HER-2 Positive Metastatic Colorectal Cancer.

Phase II Single Arm Study of Upfront Trastuzumab-Deruxtecan Plus Capecitabine and Bevacizumab for Patients With HER-2 Positive Metastatic Colorectal Cancer: the CHIMERA Study.

Sponsor

Gruppo Oncologico del Nord-Ovest

Enrollment

42 participants

Start Date

Oct 20, 2025

Study Type

INTERVENTIONAL

Conditions

Colorectal, Cancer Rectal Adenocarcinoma Colorectal Adenocarcinoma Rectal Cancer, Adenocarcinoma Rectal Cancer, Metastatic Colon Cancer Metastatic Colon Cancer Adenocarcinoma

Summary

The aim of this study is to evaluate the activity of first-line trastuzumab-deruxtecan, capecitabine and bevacizumab in terms of overall response rate for patients with HER-2 positive metastatic/locally advanced unresectable colorectal cancer

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of three cancer drugs — trastuzumab deruxtecan (T-DXd), capecitabine (an oral chemo pill), and bevacizumab — as a first-line treatment for colorectal cancer that has spread and has a protein called HER2 overexpressed on tumor cells. **You may be eligible if...** - You are 18 or older and able to function reasonably well day-to-day (ECOG score 0-2) - You have confirmed metastatic or inoperable colorectal cancer (colon or rectal adenocarcinoma) - Your tumor tests positive for HER2 overexpression or amplification - You have not previously received any systemic treatment for metastatic colorectal cancer - Your heart, liver, kidneys, and blood counts are within acceptable ranges **You may NOT be eligible if...** - You have received prior treatment with an anti-HER2 drug or a topoisomerase I inhibitor - You have active brain metastases requiring steroids - You have a history of serious lung disease or current pneumonitis - You have had a heart attack or significant heart problems within the past 6 months - You are pregnant or breastfeeding - You have active hepatitis B, hepatitis C, or HIV Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTrastuzumab-Deruxtecan (T-DXd)

T-DXd at the dose of 5.4 mg/kg intravenous (as a 90 +/- 10 minute infusion) on day 1 every 3 weeks

DRUGCapecitabine

1000 mg/sqm bis in die (BID) orally on days 1-14 every 3 weeks

DRUGBevacizumab

7.5 mg/kg intravenous (as a 30 minute infusion) on day 1 every 3 weeks

Locations(28)

Hopital Prive Jean Mermoz

Lyon, France

Hôpital La Timone - APHM

Marseille, France

Hopital Saint Louis

Paris, France

Centre Hospitalier Universitaire Reims

Reims, France

Groupe Hospitalier Rance Emeraude

St-Malo, France

Charite Universitaetsmedizin

Berlin, Germany

Krankenhaus Nordwest

Frankfurt, Germany

Istituto Tumori Bari Giovanni Paolo II

Bari, Bari, Italy

A.O.U Careggi

Florence, Firenze, Italy

Istituto Europeo Di Oncologia S.r.l.

Milan, Italy, Italy

Azienda Unita Sanitaria Locale Della Romagna

Ravenna, Italy, Italy

Humanitas Mirasole S.p.A.

Rozzano, Italy, Italy

Azienda Ospedaliera Card. G. Panico

Tricase, LE, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori - Milano

Milan, Milan, Italy

Azienda Ospedaliero Universitaria di Modena

Modena, Missouri, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, RM, Italy

Policlinico Tor Vergata Roma

Roma, Roma, Italy

IFO-Regina Elena Institute for Cancer Research

Roma, Roma, Italy

Azienda Sanitaria Universitaria Friuli Centrale

Udine, Udine, Italy

Azienda Ospedaliera Universitaria Luigi Vanvitelli

Naples, Italy

IRCCS Istituto Nazionale Tumori "Fondazione Giovanni Pascale"

Naples, Italy

Fondazione IRCCS Istituto Oncologico Veneto

Padova, Italy

U.O. Oncologia Medica 2 Universitaria - Azienda Ospedaliero-Universitaria Pisana Dipartimento di Ricerca Traslazionale e Nuove Tecnologie - University of Pisa

Pisa, Italy

Hospital del Mar

Barcelona, Spain

Hospital Universitario Virgen de las Nieves

Granada, Spain

Hospital Universitario Fundación Jiménez

Madrid, Spain

Hospital Clínico Universitario Santiago de Compostela

Santiago de Compostela, Spain

Hospital Clínico Universitario de Valencia

Valencia, Spain

View Full Details on ClinicalTrials.gov