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

Sponsor
Gruppo Oncologico del Nord-Ovest
Study ID
NCT07407465
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab-Deruxtecan (T-DXd) — DRUG
    T-DXd at the dose of 5.4 mg/kg intravenous (as a 90 +/- 10 minute infusion) on day 1 every 3 weeks
  • Capecitabine — DRUG
    1000 mg/sqm bis in die (BID) orally on days 1-14 every 3 weeks
  • Bevacizumab — DRUG
    7.5 mg/kg intravenous (as a 30 minute infusion) on day 1 every 3 weeks

Study Details

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

Key Dates

Start date
Oct 20, 2025
Status verified
Feb 2026
Primary completion
Oct 20, 2027
Completion
Oct 20, 2027

Study Design

Enrollment
42 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Trastuzumab-deruxtecan, capecitabine, bevacizumab
    * Trastuzumab-deruxtecan 5.4 mg/Kg, IV, d1 q3w; * Capecitabine 1000 mg/sqm B.I.D, oral, dd1-14 q3w; * Bevacizumab 7.5 mg/kg, IV, d1 q3w; Treatment will be received until progressive disease, unacceptable toxicity, consent withdrawal, investigator's decision or study termination, whichever occurs first.

Primary Outcome Measure

Overall Response Rate [ Time Frame: 24 months ]

Central Contacts

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