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

NCT07407465 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-02-17

No results posted yet for this study

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

Conditions

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

Interventions

DRUG

Trastuzumab-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

DRUG

Capecitabine

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

DRUG

Bevacizumab

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

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Gruppo Oncologico del Nord-Ovest

    lead OTHER

Principal Investigators

  • Filippo Pietrantonio, MD · Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-20
Primary Completion
2027-10-20
Completion
2027-10-20

Countries

  • France
  • Germany
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07407465 on ClinicalTrials.gov